Pharmaceutical Quality - Chemistry, Manufacturing and Controls (PQ-CMC) Submissions to FDA
2.0.0 - STU2

Pharmaceutical Quality - Chemistry, Manufacturing and Controls (PQ-CMC) Submissions to FDA, published by HL7 International / Biomedical Research and Regulation. This guide is not an authorized publication; it is the continuous build for version 2.0.0 built by the FHIR (HL7® FHIR® Standard) CI Build. This version is based on the current content of https://github.com/HL7/FHIR-us-pq-cmc-fda/ and changes regularly. See the Directory of published versions

## Resource Profile: ComponentSubstance - XML Profile

Page standards status: Trial-use | Maturity Level: 2

XML representation of the pqcmc-component-substance resource profile.

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    <StructureDefinition xmlns="http://hl7.org/fhir">
      <id value="pqcmc-component-substance"/>
      <text>
        <status value="extensions"/>
        <div xmlns="http://www.w3.org/1999/xhtml"><p class="res-header-id"><b>Generated Narrative: StructureDefinition pqcmc-component-substance</b></p><a name="pqcmc-component-substance"> </a><a name="hcpqcmc-component-substance"> </a><table border="0" cellpadding="0" cellspacing="0" style="border: 0px #F0F0F0 solid; font-size: 11px; font-family: verdana; vertical-align: top;"><tr style="border: 1px #F0F0F0 solid; font-size: 11px; font-family: verdana; vertical-align: top"><th style="vertical-align: top; text-align : var(--ig-left,left); background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; padding-top: 3px; padding-bottom: 3px" class="hierarchy"><a href="https://build.fhir.org/ig/FHIR/ig-guidance/readingIgs.html#table-views" title="The logical name of the element">Name</a></th><th style="vertical-align: top; text-align : var(--ig-left,left); background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; padding-top: 3px; padding-bottom: 3px" class="hierarchy"><a href="https://build.fhir.org/ig/FHIR/ig-guidance/readingIgs.html#table-views" title="Information about the use of the element">Flags</a></th><th style="vertical-align: top; text-align : var(--ig-left,left); background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; padding-top: 3px; padding-bottom: 3px" class="hierarchy"><a href="https://build.fhir.org/ig/FHIR/ig-guidance/readingIgs.html#table-views" title="Minimum and Maximum # of times the element can appear in the instance">Card.</a></th><th style="vertical-align: top; text-align : var(--ig-left,left); background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; padding-top: 3px; padding-bottom: 3px; width: 100px" class="hierarchy"><a href="https://build.fhir.org/ig/FHIR/ig-guidance/readingIgs.html#table-views" title="Reference to the type of the element">Type</a></th><th style="vertical-align: top; text-align : var(--ig-left,left); background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; padding-top: 3px; padding-bottom: 3px" class="hierarchy"><a href="https://build.fhir.org/ig/FHIR/ig-guidance/readingIgs.html#table-views" title="Additional information about the element">Description &amp; Constraints</a><span style="float: right"><a href="https://build.fhir.org/ig/FHIR/ig-guidance/readingIgs.html#table-views" title="Legend for this format"><img src="data:image/png;base64, " alt="doco" style="background-color: inherit"/></a></span></th></tr><tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white"><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck1.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_resource.png" alt="." style="background-color: white; background-color: inherit" title="Resource" class="hierarchy"/> <a href="StructureDefinition-pqcmc-component-substance-definitions.html#SubstanceDefinition">SubstanceDefinition</a><a name="SubstanceDefinition"> </a></td><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a style="padding-left: 3px; padding-right: 3px; border: 1px maroon solid; font-weight: bold; color: #301212; background-color: #fdf4f4;; padding-left: 3px; padding-right: 3px; border: 1px maroon solid; font-weight: bold; color: #301212; background-color: #fdf4f4;" href="http://hl7.org/fhir/R5/conformance-rules.html#constraints" title="This element has or is affected by constraints ( cmc-when-unii-required, cmc-name-isbt, cmc-source-material )">C</a></td><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><span style="opacity: 0.5">0</span><span style="opacity: 0.5">..</span><span style="opacity: 0.5">*</span></td><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="http://hl7.org/fhir/R5/substancedefinition.html">SubstanceDefinition</a></td><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><span style="opacity: 0.5">The detailed description of a substance, typically at a level beyond what is used for prescribing</span><br class="constraint"/><span title="null" class="constraint">Constraints: </span><span style="font-weight:bold" title="A UNII is required in code for any of these categories: 'Chemical', 'Mixture', 'Nucleic Acids','Polymer'. A UniProt code is required for any of these categories: 'Protein'" class="constraint">cmc-when-unii-required</span><span title="null" class="constraint">, </span><span style="font-weight:bold" title="Name.type ISBT 128 required for blood products." class="constraint">cmc-name-isbt</span><span title="null" class="constraint">, </span><span style="font-weight:bold" title="IF raw material source type equals Microbial, Animal, Plant, Insect or Human THEN the 4 source related attributes are required and the manufacturer and supplier information is highly desirable." class="constraint">cmc-source-material</span></td></tr>
    <tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7"><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck10.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_element.gif" alt="." style="background-color: #F7F7F7; background-color: inherit" title="Element" class="hierarchy"/> <a href="StructureDefinition-pqcmc-component-substance-definitions.html#SubstanceDefinition.identifier">identifier</a><a name="SubstanceDefinition.identifier"> </a></td><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><span style="opacity: 0.5">0</span>..1</td><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a style="opacity: 0.5; opacity: 0.5" href="http://hl7.org/fhir/R5/datatypes.html#Identifier">Identifier</a></td><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">optional user designated identifier</td></tr>
    <tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white"><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck10.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_element.gif" alt="." style="background-color: white; background-color: inherit" title="Element" class="hierarchy"/> <a href="StructureDefinition-pqcmc-component-substance-definitions.html#SubstanceDefinition.classification" title="A controlled vocabulary as provided by the prEN ISO 11238 - Health informatics identification of medicinal products - Structures and controlled vocabularies for drug substances to group drug substances at a relatively high level acording to the Substance and the Substance Preparation Model.
    [Source: Adapted from 'Logical model of the classification and identification of pharmaceutical and medicinal Products', HL7]">classification</a><a name="SubstanceDefinition.classification"> </a></td><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><span style="padding-left: 3px; padding-right: 3px; color: white; background-color: red" title="This element must be supported">S</span></td><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">1..1</td><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a style="opacity: 0.5; opacity: 0.5" href="http://hl7.org/fhir/R5/datatypes.html#CodeableConcept">CodeableConcept</a></td><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">Substance Type<br class="binding"/><span style="font-weight:bold" title="null" class="binding">Binding: </span><a href="ValueSet-substance-classification.html" title="http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/substance-classification" class="binding">Substance Classification</a><span title="null" class="binding"> (</span><a href="http://hl7.org/fhir/R5/terminologies.html#required" title="To be conformant, the concept in this element SHALL be from the specified value set." class="binding">required</a><span title="null" class="binding">)</span></td></tr>
    <tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7"><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck10.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_element.gif" alt="." style="background-color: #F7F7F7; background-color: inherit" title="Element" class="hierarchy"/> <a href="StructureDefinition-pqcmc-component-substance-definitions.html#SubstanceDefinition.grade" title="The established benchmark to which the component complies. [Source: SME Defined]
    Examples: USP/NF, EP, Company Standard">grade</a><a name="SubstanceDefinition.grade"> </a></td><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">1..<span style="opacity: 0.5">*</span></td><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a style="opacity: 0.5; opacity: 0.5" href="http://hl7.org/fhir/R5/datatypes.html#CodeableConcept">CodeableConcept</a></td><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">Quality Standard<br class="binding"/><span style="font-weight:bold" title="null" class="binding">Binding: </span><a href="ValueSet-pqcmc-quality-benchmark-terminology.html" title="http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-quality-benchmark-terminology" class="binding">Quality Benchmark Terminology</a><span title="null" class="binding"> (</span><a href="http://hl7.org/fhir/R5/terminologies.html#required" title="To be conformant, the concept in this element SHALL be from the specified value set." class="binding">required</a><span title="null" class="binding">)</span></td></tr>
    <tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white"><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck10.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_reference.png" alt="." style="background-color: white; background-color: inherit" title="Reference to another Resource" class="hierarchy"/> <a href="StructureDefinition-pqcmc-component-substance-definitions.html#SubstanceDefinition.manufacturer">manufacturer</a><a name="SubstanceDefinition.manufacturer"> </a></td><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><span style="padding-left: 3px; padding-right: 3px; color: white; background-color: red" title="This element must be supported">S</span></td><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><span style="opacity: 0.5">0</span>..1</td><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="StructureDefinition-literal-reference.html" title="Literal Reference">LiteralReference</a>(<a href="StructureDefinition-cmc-organization.html">Basic Organization</a>)<a href="http://hl7.org/fhir/R5/valueset-resource-aggregation-mode.html"> {</a><a href="http://hl7.org/fhir/R5/valueset-resource-aggregation-mode.html" title="When the resource is in a Bundle, the resource the reference points to will be found in the same bundle as the resource that includes the reference.">b</a><a href="http://hl7.org/fhir/R5/valueset-resource-aggregation-mode.html">}</a></td><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><span style="opacity: 0.5">The entity that creates, makes, produces or fabricates the substance</span></td></tr>
    <tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7"><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck10.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_reference.png" alt="." style="background-color: #F7F7F7; background-color: inherit" title="Reference to another Resource" class="hierarchy"/> <a href="StructureDefinition-pqcmc-component-substance-definitions.html#SubstanceDefinition.supplier">supplier</a><a name="SubstanceDefinition.supplier"> </a></td><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><span style="padding-left: 3px; padding-right: 3px; color: white; background-color: red" title="This element must be supported">S</span></td><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><span style="opacity: 0.5">0</span>..1</td><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="StructureDefinition-literal-reference.html" title="Literal Reference">LiteralReference</a>(<a href="StructureDefinition-cmc-organization.html">Basic Organization</a>)<a href="http://hl7.org/fhir/R5/valueset-resource-aggregation-mode.html"> {</a><a href="http://hl7.org/fhir/R5/valueset-resource-aggregation-mode.html" title="When the resource is in a Bundle, the resource the reference points to will be found in the same bundle as the resource that includes the reference.">b</a><a href="http://hl7.org/fhir/R5/valueset-resource-aggregation-mode.html">}</a></td><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><span style="opacity: 0.5">An entity that is the source for the substance. It may be different from the manufacturer</span></td></tr>
    <tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white"><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck11.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_element.gif" alt="." style="background-color: white; background-color: inherit" title="Element" class="hierarchy"/> <a href="StructureDefinition-pqcmc-component-substance-definitions.html#SubstanceDefinition.structure">structure</a><a name="SubstanceDefinition.structure"> </a></td><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a style="padding-left: 3px; padding-right: 3px; border: 1px maroon solid; font-weight: bold; color: #301212; background-color: #fdf4f4;; padding-left: 3px; padding-right: 3px; border: 1px maroon solid; font-weight: bold; color: #301212; background-color: #fdf4f4;" href="http://hl7.org/fhir/R5/conformance-rules.html#constraints" title="This element has or is affected by constraints ( cmc-structure-representation-required )">C</a></td><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><span style="opacity: 0.5">0</span><span style="opacity: 0.5">..</span><span style="opacity: 0.5">1</span></td><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a style="opacity: 0.5; opacity: 0.5" href="http://hl7.org/fhir/R5/types.html#BackboneElement">BackboneElement</a></td><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><span style="opacity: 0.5">Structural information</span><br class="constraint"/><span title="null" class="constraint">Constraints: </span><span style="font-weight:bold" title="Either a file or string structure representation is required" class="constraint">cmc-structure-representation-required</span></td></tr>
    <tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7"><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck103.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin_end.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_slice.png" alt="." style="background-color: #F7F7F7; background-color: inherit" title="Slice Definition" class="hierarchy"/> <a style="font-style: italic; font-style: italic" href="StructureDefinition-pqcmc-component-substance-definitions.html#SubstanceDefinition.structure.representation">Slices for representation</a><a name="SubstanceDefinition.structure.representation"> </a></td><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><span style="padding-left: 3px; padding-right: 3px; color: white; background-color: red; font-style: italic" title="This element must be supported">S</span></td><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><span style="font-style: italic"/><span style="opacity: 0.5; font-style: italic">0</span><span style="opacity: 0.5; font-style: italic">..</span><span style="opacity: 0.5; font-style: italic">*</span></td><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a style="opacity: 0.5; font-style: italic; opacity: 0.5; font-style: italic" href="http://hl7.org/fhir/R5/types.html#BackboneElement">BackboneElement</a></td><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><span style="font-style: italic">Impurity Structure Graphic | Impurity Structure Data File</span><br style="font-style: italic"/><span style="font-weight:bold; font-style: italic">Slice: </span><span style="font-style: italic">Unordered, Closed by value:type</span></td></tr>
    <tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white"><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck1033.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_blank.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin_slicer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_element.gif" alt="." style="background-color: white; background-color: inherit" title="Element" class="hierarchy"/> representation:All Slices<a name="SubstanceDefinition.structure.representation.2"> </a></td><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">Content/Rules for all slices</td></tr>
    <tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7"><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck10320.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_blank.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline_slicer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin_end_slicer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_element.gif" alt="." style="background-color: #F7F7F7; background-color: inherit" title="Element" class="hierarchy"/> <a href="StructureDefinition-pqcmc-component-substance-definitions.html#SubstanceDefinition.structure.representation.type">type</a><a name="SubstanceDefinition.structure.representation.type"> </a></td><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><span style="padding-left: 3px; padding-right: 3px; color: white; background-color: red" title="This element must be supported">S</span></td><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">1..<span style="opacity: 0.5">1</span></td><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a style="opacity: 0.5; opacity: 0.5" href="http://hl7.org/fhir/R5/datatypes.html#CodeableConcept">CodeableConcept</a></td><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><span style="opacity: 0.5">The kind of structural representation (e.g. full, partial)</span><br class="binding"/><span style="font-weight:bold" title="null" class="binding">Binding: </span><a href="ValueSet-pqcmc-representation-types.html" title="http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-representation-types" class="binding">Representation Types</a><span title="null" class="binding"> (</span><a href="http://hl7.org/fhir/R5/terminologies.html#required" title="To be conformant, the concept in this element SHALL be from the specified value set." class="binding">required</a><span title="null" class="binding">)</span></td></tr>
    <tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white"><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck1035.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_blank.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin_slicer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_slice_item.png" alt="." style="background-color: white; background-color: inherit" title="Slice Item" class="hierarchy"/> <a href="StructureDefinition-pqcmc-component-substance-definitions.html#SubstanceDefinition.structure.representation:graphic" title="Slice graphic">representation:graphic</a><a name="SubstanceDefinition.structure.representation.3"> </a></td><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><span style="padding-left: 3px; padding-right: 3px; color: white; background-color: red" title="This element must be supported">S</span></td><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">0..1</td><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a style="opacity: 0.5; opacity: 0.5" href="http://hl7.org/fhir/R5/types.html#BackboneElement">BackboneElement</a></td><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">A graphical, displayable depiction of the structure (e.g. an SVG, PNG)</td></tr>
    <tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7"><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck10351.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_blank.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline_slicer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin_slice.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_element.gif" alt="." style="background-color: #F7F7F7; background-color: inherit" title="Element" class="hierarchy"/> <a href="StructureDefinition-pqcmc-component-substance-definitions.html#SubstanceDefinition.structure.representation:graphic.type">type</a><a name="SubstanceDefinition.structure.representation.type.2"> </a></td><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><span style="opacity: 0.5">1</span><span style="opacity: 0.5">..</span><span style="opacity: 0.5">1</span></td><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a style="opacity: 0.5; opacity: 0.5" href="http://hl7.org/fhir/R5/datatypes.html#CodeableConcept">CodeableConcept</a></td><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">Graphic<br/><span style="font-weight:bold">Required Pattern: </span><span style="color: darkgreen">At least the following</span></td></tr>
    <tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white"><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck103501.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_blank.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline_slicer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline_slice.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin_end.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_fixed.gif" alt="." style="background-color: white; background-color: inherit" title="Fixed Value" class="hierarchy"/> <a href="http://hl7.org/fhir/R5/datatypes-definitions.html#CodeableConcept.coding">coding</a></td><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">1..*</td><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="http://hl7.org/fhir/R5/datatypes.html#Coding">Coding</a></td><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">Code defined by a terminology system<br/><span style="font-weight: bold">Fixed Value: </span><span style="color: darkgreen">(complex)</span></td></tr>
    <tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7"><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck1035010.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_blank.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline_slicer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline_slice.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_blank.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_fixed.gif" alt="." style="background-color: #F7F7F7; background-color: inherit" title="Fixed Value" class="hierarchy"/> <a href="http://hl7.org/fhir/R5/datatypes-definitions.html#Coding.system">system</a></td><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">1..1</td><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="http://hl7.org/fhir/R5/datatypes.html#uri">uri</a></td><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">Identity of the terminology system<br/><span style="font-weight: bold">Fixed Value: </span><span style="color: darkgreen">http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl</span></td></tr>
    <tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white"><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck1035000.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_blank.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline_slicer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline_slice.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_blank.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin_end.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_fixed.gif" alt="." style="background-color: white; background-color: inherit" title="Fixed Value" class="hierarchy"/> <a href="http://hl7.org/fhir/R5/datatypes-definitions.html#Coding.code">code</a></td><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">1..1</td><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="http://hl7.org/fhir/R5/datatypes.html#code">code</a></td><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">Symbol in syntax defined by the system<br/><span style="font-weight: bold">Fixed Value: </span><span style="color: darkgreen">C54273</span></td></tr>
    <tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7"><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck10340.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_blank.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline_slicer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin_end_slice.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_reference.png" alt="." style="background-color: #F7F7F7; background-color: inherit" title="Reference to another Resource" class="hierarchy"/> <a href="StructureDefinition-pqcmc-component-substance-definitions.html#SubstanceDefinition.structure.representation:graphic.document" title="A pictorial representation of the structure of the impurity substance.
    [Source: SME Defined] Note: Refer to the 'Acceptable File Formats for
    use in eCTD' Example: This is the representation of the molecule CH3OH,
    or the sequence SHLVEALALVAGERG.">document</a><a name="SubstanceDefinition.structure.representation.document"> </a></td><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">1..<span style="opacity: 0.5">1</span></td><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="StructureDefinition-literal-reference.html" title="Literal Reference">LiteralReference</a>(<a href="StructureDefinition-pqcmc-graphic-reference.html">Graphic Reference</a>)<a href="http://hl7.org/fhir/R5/valueset-resource-aggregation-mode.html"> {</a><a href="http://hl7.org/fhir/R5/valueset-resource-aggregation-mode.html" title="When the resource is in a Bundle, the resource the reference points to will be found in the same bundle as the resource that includes the reference.">b</a><a href="http://hl7.org/fhir/R5/valueset-resource-aggregation-mode.html">}</a></td><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">Impurity Structure Graphic</td></tr>
    <tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white"><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck1035.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_blank.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin_slicer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_slice_item.png" alt="." style="background-color: white; background-color: inherit" title="Slice Item" class="hierarchy"/> <a href="StructureDefinition-pqcmc-component-substance-definitions.html#SubstanceDefinition.structure.representation:structureFile" title="Slice structureFile">representation:structureFile</a><a name="SubstanceDefinition.structure.representation.4"> </a></td><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><span style="padding-left: 3px; padding-right: 3px; color: white; background-color: red" title="This element must be supported">S</span></td><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">0..*</td><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a style="opacity: 0.5; opacity: 0.5" href="http://hl7.org/fhir/R5/types.html#BackboneElement">BackboneElement</a></td><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">machine-readable representation -- attached file<br/></td></tr>
    <tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7"><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck10351.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_blank.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline_slicer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin_slice.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_element.gif" alt="." style="background-color: #F7F7F7; background-color: inherit" title="Element" class="hierarchy"/> <a href="StructureDefinition-pqcmc-component-substance-definitions.html#SubstanceDefinition.structure.representation:structureFile.type">type</a><a name="SubstanceDefinition.structure.representation.type.3"> </a></td><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><span style="opacity: 0.5">1</span><span style="opacity: 0.5">..</span><span style="opacity: 0.5">1</span></td><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a style="opacity: 0.5; opacity: 0.5" href="http://hl7.org/fhir/R5/datatypes.html#CodeableConcept">CodeableConcept</a></td><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">Structure File<br/><span style="font-weight:bold">Required Pattern: </span><span style="color: darkgreen">At least the following</span></td></tr>
    <tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white"><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck103501.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_blank.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline_slicer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline_slice.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin_end.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_fixed.gif" alt="." style="background-color: white; background-color: inherit" title="Fixed Value" class="hierarchy"/> <a href="http://hl7.org/fhir/R5/datatypes-definitions.html#CodeableConcept.coding">coding</a></td><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">1..*</td><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="http://hl7.org/fhir/R5/datatypes.html#Coding">Coding</a></td><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">Code defined by a terminology system<br/><span style="font-weight: bold">Fixed Value: </span><span style="color: darkgreen">(complex)</span></td></tr>
    <tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7"><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck1035010.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_blank.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline_slicer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline_slice.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_blank.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_fixed.gif" alt="." style="background-color: #F7F7F7; background-color: inherit" title="Fixed Value" class="hierarchy"/> <a href="http://hl7.org/fhir/R5/datatypes-definitions.html#Coding.system">system</a></td><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">1..1</td><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="http://hl7.org/fhir/R5/datatypes.html#uri">uri</a></td><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">Identity of the terminology system<br/><span style="font-weight: bold">Fixed Value: </span><span style="color: darkgreen">http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl</span></td></tr>
    <tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white"><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck1035000.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_blank.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline_slicer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline_slice.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_blank.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin_end.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_fixed.gif" alt="." style="background-color: white; background-color: inherit" title="Fixed Value" class="hierarchy"/> <a href="http://hl7.org/fhir/R5/datatypes-definitions.html#Coding.code">code</a></td><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">1..1</td><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="http://hl7.org/fhir/R5/datatypes.html#code">code</a></td><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">Symbol in syntax defined by the system<br/><span style="font-weight: bold">Fixed Value: </span><span style="color: darkgreen">C103240</span></td></tr>
    <tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7"><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck10340.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_blank.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline_slicer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin_end_slice.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_reference.png" alt="." style="background-color: #F7F7F7; background-color: inherit" title="Reference to another Resource" class="hierarchy"/> <a href="StructureDefinition-pqcmc-component-substance-definitions.html#SubstanceDefinition.structure.representation:structureFile.document">document</a><a name="SubstanceDefinition.structure.representation.document.2"> </a></td><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><span style="padding-left: 3px; padding-right: 3px; color: white; background-color: red" title="This element must be supported">S</span></td><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">1..<span style="opacity: 0.5">1</span></td><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="StructureDefinition-literal-reference.html" title="Literal Reference">LiteralReference</a>(<a href="StructureDefinition-pqcmc-structure-reference.html">Structure Data Reference</a>)<a href="http://hl7.org/fhir/R5/valueset-resource-aggregation-mode.html"> {</a><a href="http://hl7.org/fhir/R5/valueset-resource-aggregation-mode.html" title="When the resource is in a Bundle, the resource the reference points to will be found in the same bundle as the resource that includes the reference.">b</a><a href="http://hl7.org/fhir/R5/valueset-resource-aggregation-mode.html">}</a></td><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">Impurity Chemical Structure Data (files, e.g. .SDF, .CIF)</td></tr>
    <tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white"><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck1025.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_blank.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin_end_slicer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_slice_item.png" alt="." style="background-color: white; background-color: inherit" title="Slice Item" class="hierarchy"/> <a href="StructureDefinition-pqcmc-component-substance-definitions.html#SubstanceDefinition.structure.representation:structureString" title="Slice structureString">representation:structureString</a><a name="SubstanceDefinition.structure.representation.5"> </a></td><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><span style="padding-left: 3px; padding-right: 3px; color: white; background-color: red" title="This element must be supported">S</span></td><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">0..*</td><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a style="opacity: 0.5; opacity: 0.5" href="http://hl7.org/fhir/R5/types.html#BackboneElement">BackboneElement</a></td><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">machine-readable representation -- plain text<br/></td></tr>
    <tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7"><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck10251.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_blank.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_blank.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin_slice.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_element.gif" alt="." style="background-color: #F7F7F7; background-color: inherit" title="Element" class="hierarchy"/> <a href="StructureDefinition-pqcmc-component-substance-definitions.html#SubstanceDefinition.structure.representation:structureString.type">type</a><a name="SubstanceDefinition.structure.representation.type.4"> </a></td><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><span style="opacity: 0.5">1</span><span style="opacity: 0.5">..</span><span style="opacity: 0.5">1</span></td><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a style="opacity: 0.5; opacity: 0.5" href="http://hl7.org/fhir/R5/datatypes.html#CodeableConcept">CodeableConcept</a></td><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">Structure Textual<br/><span style="font-weight:bold">Required Pattern: </span><span style="color: darkgreen">At least the following</span></td></tr>
    <tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white"><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck102501.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_blank.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_blank.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline_slice.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin_end.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_fixed.gif" alt="." style="background-color: white; background-color: inherit" title="Fixed Value" class="hierarchy"/> <a href="http://hl7.org/fhir/R5/datatypes-definitions.html#CodeableConcept.coding">coding</a></td><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">1..*</td><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="http://hl7.org/fhir/R5/datatypes.html#Coding">Coding</a></td><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">Code defined by a terminology system<br/><span style="font-weight: bold">Fixed Value: </span><span style="color: darkgreen">(complex)</span></td></tr>
    <tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7"><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck1025010.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_blank.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_blank.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline_slice.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_blank.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_fixed.gif" alt="." style="background-color: #F7F7F7; background-color: inherit" title="Fixed Value" class="hierarchy"/> <a href="http://hl7.org/fhir/R5/datatypes-definitions.html#Coding.system">system</a></td><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">1..1</td><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="http://hl7.org/fhir/R5/datatypes.html#uri">uri</a></td><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">Identity of the terminology system<br/><span style="font-weight: bold">Fixed Value: </span><span style="color: darkgreen">http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl</span></td></tr>
    <tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white"><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck1025000.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_blank.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_blank.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline_slice.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_blank.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin_end.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_fixed.gif" alt="." style="background-color: white; background-color: inherit" title="Fixed Value" class="hierarchy"/> <a href="http://hl7.org/fhir/R5/datatypes-definitions.html#Coding.code">code</a></td><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">1..1</td><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="http://hl7.org/fhir/R5/datatypes.html#code">code</a></td><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">Symbol in syntax defined by the system<br/><span style="font-weight: bold">Fixed Value: </span><span style="color: darkgreen">C45253</span></td></tr>
    <tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7"><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck10250.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_blank.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_blank.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin_slice.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_element.gif" alt="." style="background-color: #F7F7F7; background-color: inherit" title="Element" class="hierarchy"/> <a href="StructureDefinition-pqcmc-component-substance-definitions.html#SubstanceDefinition.structure.representation:structureString.representation" title="A machine-readable representation of the structure of the chemical. [Source: SME Defined]
    Examples: SMILES, INCHI">representation</a><a name="SubstanceDefinition.structure.representation.representation"> </a></td><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><span style="padding-left: 3px; padding-right: 3px; color: white; background-color: red" title="This element must be supported">S</span></td><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">1..<span style="opacity: 0.5">1</span></td><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a style="opacity: 0.5; opacity: 0.5" href="http://hl7.org/fhir/R5/datatypes.html#string">string</a></td><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">Impurity Chemical Structure Data (short, plain text representations, e.g. SMILES)</td></tr>
    <tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white"><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck10240.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_blank.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_blank.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin_end_slice.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_element.gif" alt="." style="background-color: white; background-color: inherit" title="Element" class="hierarchy"/> <a href="StructureDefinition-pqcmc-component-substance-definitions.html#SubstanceDefinition.structure.representation:structureString.format">format</a><a name="SubstanceDefinition.structure.representation.format"> </a></td><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><span style="padding-left: 3px; padding-right: 3px; color: white; background-color: red" title="This element must be supported">S</span></td><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">1..<span style="opacity: 0.5">1</span></td><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a style="opacity: 0.5; opacity: 0.5" href="http://hl7.org/fhir/R5/datatypes.html#CodeableConcept">CodeableConcept</a></td><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">Drug Substance Impurity Method Type<br class="binding"/><span style="font-weight:bold" title="null" class="binding">Binding: </span><a href="ValueSet-pqcmc-chemical-structure-datafile-type-terminology.html" title="http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-chemical-structure-datafile-type-terminology" class="binding">Chemical Structure Data File Type Terminology</a><span title="null" class="binding"> (</span><a href="http://hl7.org/fhir/R5/terminologies.html#required" title="To be conformant, the concept in this element SHALL be from the specified value set." class="binding">required</a><span title="null" class="binding">)</span></td></tr>
    <tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7"><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck13.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_slice.png" alt="." style="background-color: #F7F7F7; background-color: inherit" title="Slice Definition" class="hierarchy"/> <a style="font-style: italic; font-style: italic" href="StructureDefinition-pqcmc-component-substance-definitions.html#SubstanceDefinition.code">Slices for code</a><a name="SubstanceDefinition.code"> </a></td><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><span style="padding-left: 3px; padding-right: 3px; color: white; background-color: red; font-style: italic" title="This element must be supported">S</span></td><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><span style="font-style: italic"/><span style="font-style: italic">1</span><span style="font-style: italic">..</span><span style="opacity: 0.5; font-style: italic">*</span></td><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a style="opacity: 0.5; font-style: italic; opacity: 0.5; font-style: italic" href="http://hl7.org/fhir/R5/types.html#BackboneElement">BackboneElement</a></td><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><span style="opacity: 0.5; font-style: italic">Codes associated with the substance</span><br style="font-style: italic"/><span style="font-weight:bold; font-style: italic">Slice: </span><span style="font-style: italic">Unordered, Open by value:code.coding.system</span></td></tr>
    <tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white"><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck135.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin_slicer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_slice_item.png" alt="." style="background-color: white; background-color: inherit" title="Slice Item" class="hierarchy"/> <a href="StructureDefinition-pqcmc-component-substance-definitions.html#SubstanceDefinition.code:unii" title="Slice unii: The UNII is a non-proprietary, free, unique, unambiguous, non-semantic, alphanumeric identifier based on a substance’s molecular structure and/or descriptive information. [Source: http://www.fda.gov/ForIndustry/DataStandards/SubstanceRegistrationSystem-UniqueIngredientIdentifierUNII/]
    Example: 362O9ITL9D
    Note: If a UNII does not exist, please go to http://www.fda.gov/ForIndustry/DataStandards/SubstanceRegistrationSystem-UniqueIngredientIdentifierUNII/">code:unii</a><a name="SubstanceDefinition.code.2"> </a></td><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><span style="padding-left: 3px; padding-right: 3px; color: white; background-color: red" title="This element must be supported">S</span></td><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">0..1</td><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a style="opacity: 0.5; opacity: 0.5" href="http://hl7.org/fhir/R5/types.html#BackboneElement">BackboneElement</a></td><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">UNII</td></tr>
    <tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7"><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck1341.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline_slicer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin_end_slice.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_element.gif" alt="." style="background-color: #F7F7F7; background-color: inherit" title="Element" class="hierarchy"/> <a href="StructureDefinition-pqcmc-component-substance-definitions.html#SubstanceDefinition.code:unii.code">code</a><a name="SubstanceDefinition.code.code"> </a></td><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><span style="padding-left: 3px; padding-right: 3px; color: white; background-color: red" title="This element must be supported">S</span></td><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">1..<span style="opacity: 0.5">1</span></td><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a style="opacity: 0.5; opacity: 0.5" href="http://hl7.org/fhir/R5/datatypes.html#CodeableConcept">CodeableConcept</a></td><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><span style="opacity: 0.5">The specific code</span></td></tr>
    <tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white"><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck13401.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline_slicer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_blank.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin_end.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_element.gif" alt="." style="background-color: white; background-color: inherit" title="Element" class="hierarchy"/> <a href="StructureDefinition-pqcmc-component-substance-definitions.html#SubstanceDefinition.code:unii.code.coding">coding</a><a name="SubstanceDefinition.code.code.coding"> </a></td><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><span style="padding-left: 3px; padding-right: 3px; color: white; background-color: red" title="This element must be supported">S</span></td><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">1..1</td><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a style="opacity: 0.5; opacity: 0.5" href="http://hl7.org/fhir/R5/datatypes.html#Coding">Coding</a></td><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><span style="opacity: 0.5">Code defined by a terminology system</span></td></tr>
    <tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7"><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck134000.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline_slicer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_blank.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_blank.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin_end.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_element.gif" alt="." style="background-color: #F7F7F7; background-color: inherit" title="Element" class="hierarchy"/> <a href="StructureDefinition-pqcmc-component-substance-definitions.html#SubstanceDefinition.code:unii.code.coding.system">system</a><a name="SubstanceDefinition.code.code.coding.system"> </a></td><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><span style="padding-left: 3px; padding-right: 3px; color: white; background-color: red" title="This element must be supported">S</span></td><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">1..<span style="opacity: 0.5">1</span></td><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a style="opacity: 0.5; opacity: 0.5" href="http://hl7.org/fhir/R5/datatypes.html#uri">uri</a></td><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><span style="opacity: 0.5">Identity of the terminology system</span><br/><span style="font-weight:bold">Required Pattern: </span><span style="color: darkgreen">http://fdasis.nlm.nih.gov</span></td></tr>
    <tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white"><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck125.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin_end_slicer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_slice_item.png" alt="." style="background-color: white; background-color: inherit" title="Slice Item" class="hierarchy"/> <a href="StructureDefinition-pqcmc-component-substance-definitions.html#SubstanceDefinition.code:uniProt" title="Slice uniProt: The  UniProt ID is an index to the UniProt knowledgebase,  a large resource of protein sequences and associated detailed annotation.
    It is accessible at https://www.uniprot.org/">code:uniProt</a><a name="SubstanceDefinition.code.3"> </a></td><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><span style="padding-left: 3px; padding-right: 3px; color: white; background-color: red" title="This element must be supported">S</span></td><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">0..1</td><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a style="opacity: 0.5; opacity: 0.5" href="http://hl7.org/fhir/R5/types.html#BackboneElement">BackboneElement</a></td><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">UniProt ID</td></tr>
    <tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7"><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck1241.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_blank.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin_end_slice.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_element.gif" alt="." style="background-color: #F7F7F7; background-color: inherit" title="Element" class="hierarchy"/> <a href="StructureDefinition-pqcmc-component-substance-definitions.html#SubstanceDefinition.code:uniProt.code">code</a><a name="SubstanceDefinition.code.code.2"> </a></td><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><span style="padding-left: 3px; padding-right: 3px; color: white; background-color: red" title="This element must be supported">S</span></td><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">1..<span style="opacity: 0.5">1</span></td><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a style="opacity: 0.5; opacity: 0.5" href="http://hl7.org/fhir/R5/datatypes.html#CodeableConcept">CodeableConcept</a></td><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><span style="opacity: 0.5">The specific code</span></td></tr>
    <tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white"><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck12401.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_blank.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_blank.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin_end.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_element.gif" alt="." style="background-color: white; background-color: inherit" title="Element" class="hierarchy"/> <a href="StructureDefinition-pqcmc-component-substance-definitions.html#SubstanceDefinition.code:uniProt.code.coding">coding</a><a name="SubstanceDefinition.code.code.coding.2"> </a></td><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><span style="padding-left: 3px; padding-right: 3px; color: white; background-color: red" title="This element must be supported">S</span></td><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">1..1</td><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a style="opacity: 0.5; opacity: 0.5" href="http://hl7.org/fhir/R5/datatypes.html#Coding">Coding</a></td><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><span style="opacity: 0.5">Code defined by a terminology system</span></td></tr>
    <tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7"><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck124000.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_blank.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_blank.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_blank.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin_end.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_element.gif" alt="." style="background-color: #F7F7F7; background-color: inherit" title="Element" class="hierarchy"/> <a href="StructureDefinition-pqcmc-component-substance-definitions.html#SubstanceDefinition.code:uniProt.code.coding.system">system</a><a name="SubstanceDefinition.code.code.coding.system.2"> </a></td><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><span style="padding-left: 3px; padding-right: 3px; color: white; background-color: red" title="This element must be supported">S</span></td><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">1..<span style="opacity: 0.5">1</span></td><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a style="opacity: 0.5; opacity: 0.5" href="http://hl7.org/fhir/R5/datatypes.html#uri">uri</a></td><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><span style="opacity: 0.5">Identity of the terminology system</span><br/><span style="font-weight:bold">Required Pattern: </span><span style="color: darkgreen">http://terminology.hl7.org/NamingSystem/UniProt</span></td></tr>
    <tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white"><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck13.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_slice.png" alt="." style="background-color: white; background-color: inherit" title="Slice Definition" class="hierarchy"/> <a style="font-style: italic; font-style: italic" href="StructureDefinition-pqcmc-component-substance-definitions.html#SubstanceDefinition.name" title="Substance Name is identified by its Substance Type.
    Substance Type | Product Part Ingredient Name Type: Identifies the source that assigned the product ingredient name. [Source: SME Defined]
    Examples: GSRS Preferred Term, Systematic Name, INN, USP/NF">Slices for name</a><a name="SubstanceDefinition.name"> </a></td><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><span style="padding-left: 3px; padding-right: 3px; color: white; background-color: red; font-style: italic" title="This element must be supported">S</span><a style="padding-left: 3px; padding-right: 3px; border: 1px maroon solid; font-weight: bold; color: #301212; background-color: #fdf4f4;; font-style: italic; padding-left: 3px; padding-right: 3px; border: 1px maroon solid; font-weight: bold; color: #301212; background-color: #fdf4f4;; font-style: italic" href="http://hl7.org/fhir/R5/conformance-rules.html#constraints" title="This element has or is affected by constraints ( cmc-name-preferred )">C</a></td><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><span style="font-style: italic"/><span style="font-style: italic">1</span><span style="font-style: italic">..</span><span style="opacity: 0.5; font-style: italic">*</span></td><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a style="opacity: 0.5; font-style: italic; opacity: 0.5; font-style: italic" href="http://hl7.org/fhir/R5/types.html#BackboneElement">BackboneElement</a></td><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><span style="font-style: italic">Substance Name</span><br style="font-style: italic"/><span style="font-weight:bold; font-style: italic">Slice: </span><span style="font-style: italic">Unordered, Closed by value:type</span><br style="font-style: italic" class="constraint"/><span style="font-style: italic" title="null" class="constraint">Constraints: </span><span style="font-weight:bold; font-style: italic" title="Name.preferred: at most one = true" class="constraint">cmc-name-preferred</span></td></tr>
    <tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7"><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck133.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin_slicer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_element.gif" alt="." style="background-color: #F7F7F7; background-color: inherit" title="Element" class="hierarchy"/> name:All Slices<a name="SubstanceDefinition.name.2"> </a></td><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">Content/Rules for all slices</td></tr>
    <tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white"><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck1330.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline_slicer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin_slicer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_element.gif" alt="." style="background-color: white; background-color: inherit" title="Element" class="hierarchy"/> <a href="StructureDefinition-pqcmc-component-substance-definitions.html#SubstanceDefinition.name.type">type</a><a name="SubstanceDefinition.name.type"> </a></td><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><span style="opacity: 0.5">0</span><span style="opacity: 0.5">..</span><span style="opacity: 0.5">1</span></td><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a style="opacity: 0.5; opacity: 0.5" href="http://hl7.org/fhir/R5/datatypes.html#CodeableConcept">CodeableConcept</a></td><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><span style="opacity: 0.5">Name type e.g. 'systematic',  'scientific, 'brand'</span><br class="binding"/><span style="font-weight:bold" title="null" class="binding">Binding: </span><a href="ValueSet-pqcmc-substance-name-type.html" title="http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-substance-name-type" class="binding">Substance Name Type</a><span title="null" class="binding"> (</span><a href="http://hl7.org/fhir/R5/terminologies.html#required" title="To be conformant, the concept in this element SHALL be from the specified value set." class="binding">required</a><span title="null" class="binding">)</span></td></tr>
    <tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7"><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck1320.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline_slicer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin_end_slicer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_element.gif" alt="." style="background-color: #F7F7F7; background-color: inherit" title="Element" class="hierarchy"/> <a href="StructureDefinition-pqcmc-component-substance-definitions.html#SubstanceDefinition.name.preferred">preferred</a><a name="SubstanceDefinition.name.preferred"> </a></td><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><span style="padding-left: 3px; padding-right: 3px; color: white; background-color: red" title="This element must be supported">S</span></td><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><span style="opacity: 0.5">0</span><span style="opacity: 0.5">..</span><span style="opacity: 0.5">1</span></td><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a style="opacity: 0.5; opacity: 0.5" href="http://hl7.org/fhir/R5/datatypes.html#boolean">boolean</a></td><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">True when the name type is Substance Name</td></tr>
    <tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white"><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck135.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin_slicer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_slice_item.png" alt="." style="background-color: white; background-color: inherit" title="Slice Item" class="hierarchy"/> <a href="StructureDefinition-pqcmc-component-substance-definitions.html#SubstanceDefinition.name:sub" title="Slice sub">name:sub</a><a name="SubstanceDefinition.name.3"> </a></td><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><span style="padding-left: 3px; padding-right: 3px; color: white; background-color: red" title="This element must be supported">S</span></td><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">0..1</td><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a style="opacity: 0.5; opacity: 0.5" href="http://hl7.org/fhir/R5/types.html#BackboneElement">BackboneElement</a></td><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><span style="opacity: 0.5">Names applicable to this substance</span></td></tr>
    <tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7"><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck1350.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline_slicer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin_slice.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_element.gif" alt="." style="background-color: #F7F7F7; background-color: inherit" title="Element" class="hierarchy"/> <a href="StructureDefinition-pqcmc-component-substance-definitions.html#SubstanceDefinition.name:sub.name" title="A non-branded nor registered name that meant for common use.">name</a><a name="SubstanceDefinition.name.name"> </a></td><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><span style="padding-left: 3px; padding-right: 3px; color: white; background-color: red" title="This element must be supported">S</span></td><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><span style="opacity: 0.5">1</span><span style="opacity: 0.5">..</span><span style="opacity: 0.5">1</span></td><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a style="opacity: 0.5; opacity: 0.5" href="http://hl7.org/fhir/R5/datatypes.html#string">string</a></td><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">Generic Name</td></tr>
    <tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white"><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck1351.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline_slicer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin_slice.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_element.gif" alt="." style="background-color: white; background-color: inherit" title="Element" class="hierarchy"/> <a href="StructureDefinition-pqcmc-component-substance-definitions.html#SubstanceDefinition.name:sub.type">type</a><a name="SubstanceDefinition.name.type.2"> </a></td><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><span style="padding-left: 3px; padding-right: 3px; color: white; background-color: red" title="This element must be supported">S</span></td><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">1..<span style="opacity: 0.5">1</span></td><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a style="opacity: 0.5; opacity: 0.5" href="http://hl7.org/fhir/R5/datatypes.html#CodeableConcept">CodeableConcept</a></td><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><span style="opacity: 0.5">Name type e.g. 'systematic',  'scientific, 'brand'</span><br/><span style="font-weight:bold">Required Pattern: </span><span style="color: darkgreen">At least the following</span></td></tr>
    <tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7"><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck13501.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline_slicer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline_slice.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin_end.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_fixed.gif" alt="." style="background-color: #F7F7F7; background-color: inherit" title="Fixed Value" class="hierarchy"/> <a href="http://hl7.org/fhir/R5/datatypes-definitions.html#CodeableConcept.coding">coding</a></td><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">1..*</td><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="http://hl7.org/fhir/R5/datatypes.html#Coding">Coding</a></td><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">Code defined by a terminology system<br/><span style="font-weight: bold">Fixed Value: </span><span style="color: darkgreen">(complex)</span></td></tr>
    <tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white"><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck135010.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline_slicer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline_slice.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_blank.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_fixed.gif" alt="." style="background-color: white; background-color: inherit" title="Fixed Value" class="hierarchy"/> <a href="http://hl7.org/fhir/R5/datatypes-definitions.html#Coding.system">system</a></td><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">1..1</td><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="http://hl7.org/fhir/R5/datatypes.html#uri">uri</a></td><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">Identity of the terminology system<br/><span style="font-weight: bold">Fixed Value: </span><span style="color: darkgreen">http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl</span></td></tr>
    <tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7"><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck135010.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline_slicer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline_slice.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_blank.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_fixed.gif" alt="." style="background-color: #F7F7F7; background-color: inherit" title="Fixed Value" class="hierarchy"/> <a href="http://hl7.org/fhir/R5/datatypes-definitions.html#Coding.code">code</a></td><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">1..1</td><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="http://hl7.org/fhir/R5/datatypes.html#code">code</a></td><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">Symbol in syntax defined by the system<br/><span style="font-weight: bold">Fixed Value: </span><span style="color: darkgreen">C97054</span></td></tr>
    <tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white"><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck135000.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline_slicer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline_slice.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_blank.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin_end.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_fixed.gif" alt="." style="background-color: white; background-color: inherit" title="Fixed Value" class="hierarchy"/> <a href="http://hl7.org/fhir/R5/datatypes-definitions.html#Coding.display">display</a></td><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">1..1</td><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="http://hl7.org/fhir/R5/datatypes.html#string">string</a></td><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">Representation defined by the system<br/><span style="font-weight: bold">Fixed Value: </span><span style="color: darkgreen">Generic Name</span></td></tr>
    <tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7"><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck1340.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline_slicer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin_end_slice.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_element.gif" alt="." style="background-color: #F7F7F7; background-color: inherit" title="Element" class="hierarchy"/> <a href="StructureDefinition-pqcmc-component-substance-definitions.html#SubstanceDefinition.name:sub.preferred">preferred</a><a name="SubstanceDefinition.name.preferred.2"> </a></td><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><span style="padding-left: 3px; padding-right: 3px; color: white; background-color: red" title="This element must be supported">S</span></td><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><span style="opacity: 0.5">0</span><span style="opacity: 0.5">..</span><span style="opacity: 0.5">1</span></td><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a style="opacity: 0.5; opacity: 0.5" href="http://hl7.org/fhir/R5/datatypes.html#boolean">boolean</a></td><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><span style="opacity: 0.5">True when the name type is Substance Name</span></td></tr>
    <tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white"><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck135.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin_slicer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_slice_item.png" alt="." style="background-color: white; background-color: inherit" title="Slice Item" class="hierarchy"/> <a href="StructureDefinition-pqcmc-component-substance-definitions.html#SubstanceDefinition.name:gsrs" title="Slice gsrs">name:gsrs</a><a name="SubstanceDefinition.name.4"> </a></td><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><span style="padding-left: 3px; padding-right: 3px; color: white; background-color: red" title="This element must be supported">S</span></td><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">0..1</td><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a style="opacity: 0.5; opacity: 0.5" href="http://hl7.org/fhir/R5/types.html#BackboneElement">BackboneElement</a></td><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><span style="opacity: 0.5">Names applicable to this substance</span></td></tr>
    <tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7"><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck1350.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline_slicer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin_slice.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_element.gif" alt="." style="background-color: #F7F7F7; background-color: inherit" title="Element" class="hierarchy"/> <a href="StructureDefinition-pqcmc-component-substance-definitions.html#SubstanceDefinition.name:gsrs.name" title="Default display name identified within FDA Global Substance Registration System (GSRS).">name</a><a name="SubstanceDefinition.name.name.2"> </a></td><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><span style="padding-left: 3px; padding-right: 3px; color: white; background-color: red" title="This element must be supported">S</span></td><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><span style="opacity: 0.5">1</span><span style="opacity: 0.5">..</span><span style="opacity: 0.5">1</span></td><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a style="opacity: 0.5; opacity: 0.5" href="http://hl7.org/fhir/R5/datatypes.html#string">string</a></td><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">GSRS Preferred Term</td></tr>
    <tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white"><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck1351.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline_slicer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin_slice.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_element.gif" alt="." style="background-color: white; background-color: inherit" title="Element" class="hierarchy"/> <a href="StructureDefinition-pqcmc-component-substance-definitions.html#SubstanceDefinition.name:gsrs.type">type</a><a name="SubstanceDefinition.name.type.3"> </a></td><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><span style="padding-left: 3px; padding-right: 3px; color: white; background-color: red" title="This element must be supported">S</span></td><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">1..<span style="opacity: 0.5">1</span></td><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a style="opacity: 0.5; opacity: 0.5" href="http://hl7.org/fhir/R5/datatypes.html#CodeableConcept">CodeableConcept</a></td><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><span style="opacity: 0.5">Name type e.g. 'systematic',  'scientific, 'brand'</span><br/><span style="font-weight:bold">Required Pattern: </span><span style="color: darkgreen">At least the following</span></td></tr>
    <tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7"><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck13501.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline_slicer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline_slice.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin_end.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_fixed.gif" alt="." style="background-color: #F7F7F7; background-color: inherit" title="Fixed Value" class="hierarchy"/> <a href="http://hl7.org/fhir/R5/datatypes-definitions.html#CodeableConcept.coding">coding</a></td><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">1..*</td><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="http://hl7.org/fhir/R5/datatypes.html#Coding">Coding</a></td><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">Code defined by a terminology system<br/><span style="font-weight: bold">Fixed Value: </span><span style="color: darkgreen">(complex)</span></td></tr>
    <tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white"><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck135010.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline_slicer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline_slice.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_blank.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_fixed.gif" alt="." style="background-color: white; background-color: inherit" title="Fixed Value" class="hierarchy"/> <a href="http://hl7.org/fhir/R5/datatypes-definitions.html#Coding.system">system</a></td><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">1..1</td><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="http://hl7.org/fhir/R5/datatypes.html#uri">uri</a></td><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">Identity of the terminology system<br/><span style="font-weight: bold">Fixed Value: </span><span style="color: darkgreen">http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl</span></td></tr>
    <tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7"><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck135010.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline_slicer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline_slice.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_blank.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_fixed.gif" alt="." style="background-color: #F7F7F7; background-color: inherit" title="Fixed Value" class="hierarchy"/> <a href="http://hl7.org/fhir/R5/datatypes-definitions.html#Coding.code">code</a></td><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">1..1</td><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="http://hl7.org/fhir/R5/datatypes.html#code">code</a></td><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">Symbol in syntax defined by the system<br/><span style="font-weight: bold">Fixed Value: </span><span style="color: darkgreen">C203355</span></td></tr>
    <tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white"><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck135000.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline_slicer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline_slice.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_blank.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin_end.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_fixed.gif" alt="." style="background-color: white; background-color: inherit" title="Fixed Value" class="hierarchy"/> <a href="http://hl7.org/fhir/R5/datatypes-definitions.html#Coding.display">display</a></td><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">1..1</td><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="http://hl7.org/fhir/R5/datatypes.html#string">string</a></td><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">Representation defined by the system<br/><span style="font-weight: bold">Fixed Value: </span><span style="color: darkgreen">GSRS Preferred Term</span></td></tr>
    <tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7"><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck1340.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline_slicer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin_end_slice.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_element.gif" alt="." style="background-color: #F7F7F7; background-color: inherit" title="Element" class="hierarchy"/> <a href="StructureDefinition-pqcmc-component-substance-definitions.html#SubstanceDefinition.name:gsrs.preferred">preferred</a><a name="SubstanceDefinition.name.preferred.3"> </a></td><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><span style="padding-left: 3px; padding-right: 3px; color: white; background-color: red" title="This element must be supported">S</span></td><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><span style="opacity: 0.5">0</span><span style="opacity: 0.5">..</span><span style="opacity: 0.5">1</span></td><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a style="opacity: 0.5; opacity: 0.5" href="http://hl7.org/fhir/R5/datatypes.html#boolean">boolean</a></td><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><span style="opacity: 0.5">True when the name type is Substance Name</span></td></tr>
    <tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white"><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck125.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin_end_slicer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_slice_item.png" alt="." style="background-color: white; background-color: inherit" title="Slice Item" class="hierarchy"/> <a href="StructureDefinition-pqcmc-component-substance-definitions.html#SubstanceDefinition.name:isbt" title="Slice isbt">name:isbt</a><a name="SubstanceDefinition.name.5"> </a></td><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><span style="padding-left: 3px; padding-right: 3px; color: white; background-color: red" title="This element must be supported">S</span></td><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">0..1</td><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a style="opacity: 0.5; opacity: 0.5" href="http://hl7.org/fhir/R5/types.html#BackboneElement">BackboneElement</a></td><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><span style="opacity: 0.5">Names applicable to this substance</span></td></tr>
    <tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7"><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck1250.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_blank.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin_slice.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_element.gif" alt="." style="background-color: #F7F7F7; background-color: inherit" title="Element" class="hierarchy"/> <a href="StructureDefinition-pqcmc-component-substance-definitions.html#SubstanceDefinition.name:isbt.name" title="It is the global standard for the terminology, identification, coding and labeling of medical products of human origin (including blood, cell, tissue, milk, and organ products). [Source: https://www.iccbba.org/]">name</a><a name="SubstanceDefinition.name.name.3"> </a></td><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><span style="padding-left: 3px; padding-right: 3px; color: white; background-color: red" title="This element must be supported">S</span></td><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><span style="opacity: 0.5">1</span><span style="opacity: 0.5">..</span><span style="opacity: 0.5">1</span></td><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a style="opacity: 0.5; opacity: 0.5" href="http://hl7.org/fhir/R5/datatypes.html#string">string</a></td><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">ISBT-128 DIN</td></tr>
    <tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white"><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck1251.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_blank.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin_slice.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_element.gif" alt="." style="background-color: white; background-color: inherit" title="Element" class="hierarchy"/> <a href="StructureDefinition-pqcmc-component-substance-definitions.html#SubstanceDefinition.name:isbt.type">type</a><a name="SubstanceDefinition.name.type.4"> </a></td><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><span style="padding-left: 3px; padding-right: 3px; color: white; background-color: red" title="This element must be supported">S</span></td><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">1..<span style="opacity: 0.5">1</span></td><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a style="opacity: 0.5; opacity: 0.5" href="http://hl7.org/fhir/R5/datatypes.html#CodeableConcept">CodeableConcept</a></td><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><span style="opacity: 0.5">Name type e.g. 'systematic',  'scientific, 'brand'</span><br/><span style="font-weight:bold">Required Pattern: </span><span style="color: darkgreen">At least the following</span></td></tr>
    <tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7"><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck12501.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_blank.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline_slice.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin_end.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_fixed.gif" alt="." style="background-color: #F7F7F7; background-color: inherit" title="Fixed Value" class="hierarchy"/> <a href="http://hl7.org/fhir/R5/datatypes-definitions.html#CodeableConcept.coding">coding</a></td><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">1..*</td><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="http://hl7.org/fhir/R5/datatypes.html#Coding">Coding</a></td><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">Code defined by a terminology system<br/><span style="font-weight: bold">Fixed Value: </span><span style="color: darkgreen">(complex)</span></td></tr>
    <tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white"><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck125010.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_blank.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline_slice.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_blank.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_fixed.gif" alt="." style="background-color: white; background-color: inherit" title="Fixed Value" class="hierarchy"/> <a href="http://hl7.org/fhir/R5/datatypes-definitions.html#Coding.system">system</a></td><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">1..1</td><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="http://hl7.org/fhir/R5/datatypes.html#uri">uri</a></td><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">Identity of the terminology system<br/><span style="font-weight: bold">Fixed Value: </span><span style="color: darkgreen">http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl</span></td></tr>
    <tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7"><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck125010.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_blank.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline_slice.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_blank.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_fixed.gif" alt="." style="background-color: #F7F7F7; background-color: inherit" title="Fixed Value" class="hierarchy"/> <a href="http://hl7.org/fhir/R5/datatypes-definitions.html#Coding.code">code</a></td><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">1..1</td><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="http://hl7.org/fhir/R5/datatypes.html#code">code</a></td><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">Symbol in syntax defined by the system<br/><span style="font-weight: bold">Fixed Value: </span><span style="color: darkgreen">C95517</span></td></tr>
    <tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white"><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck125000.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_blank.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline_slice.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_blank.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin_end.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_fixed.gif" alt="." style="background-color: white; background-color: inherit" title="Fixed Value" class="hierarchy"/> <a href="http://hl7.org/fhir/R5/datatypes-definitions.html#Coding.display">display</a></td><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">1..1</td><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="http://hl7.org/fhir/R5/datatypes.html#string">string</a></td><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">Representation defined by the system<br/><span style="font-weight: bold">Fixed Value: </span><span style="color: darkgreen">ISBT-128 DIN</span></td></tr>
    <tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7"><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck1240.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_blank.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin_end_slice.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_element.gif" alt="." style="background-color: #F7F7F7; background-color: inherit" title="Element" class="hierarchy"/> <a href="StructureDefinition-pqcmc-component-substance-definitions.html#SubstanceDefinition.name:isbt.preferred">preferred</a><a name="SubstanceDefinition.name.preferred.4"> </a></td><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><span style="padding-left: 3px; padding-right: 3px; color: white; background-color: red" title="This element must be supported">S</span></td><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><span style="opacity: 0.5">0</span><span style="opacity: 0.5">..</span><span style="opacity: 0.5">1</span></td><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a style="opacity: 0.5; opacity: 0.5" href="http://hl7.org/fhir/R5/datatypes.html#boolean">boolean</a></td><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><span style="opacity: 0.5">True when the name type is Substance Name</span></td></tr>
    <tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white"><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck01.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin_end.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_element.gif" alt="." style="background-color: white; background-color: inherit" title="Element" class="hierarchy"/> <a href="StructureDefinition-pqcmc-component-substance-definitions.html#SubstanceDefinition.sourceMaterial">sourceMaterial</a><a name="SubstanceDefinition.sourceMaterial"> </a></td><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><span style="padding-left: 3px; padding-right: 3px; color: white; background-color: red" title="This element must be supported">S</span></td><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><span style="opacity: 0.5">0</span><span style="opacity: 0.5">..</span><span style="opacity: 0.5">1</span></td><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a style="opacity: 0.5; opacity: 0.5" href="http://hl7.org/fhir/R5/types.html#BackboneElement">BackboneElement</a></td><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><span style="opacity: 0.5">Material or taxonomic/anatomical source</span></td></tr>
    <tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7"><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck010.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_blank.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_element.gif" alt="." style="background-color: #F7F7F7; background-color: inherit" title="Element" class="hierarchy"/> <a href="StructureDefinition-pqcmc-component-substance-definitions.html#SubstanceDefinition.sourceMaterial.type" title="A classification that provides the origin of the raw material. [Source: SME Defined]">type</a><a name="SubstanceDefinition.sourceMaterial.type"> </a></td><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><span style="padding-left: 3px; padding-right: 3px; color: white; background-color: red" title="This element must be supported">S</span></td><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><span style="opacity: 0.5">0</span><span style="opacity: 0.5">..</span><span style="opacity: 0.5">1</span></td><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a style="opacity: 0.5; opacity: 0.5" href="http://hl7.org/fhir/R5/datatypes.html#CodeableConcept">CodeableConcept</a></td><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">Source Type<br class="binding"/><span style="font-weight:bold" title="null" class="binding">Binding: </span><a href="ValueSet-pqcmc-source-type-terminology.html" title="http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-source-type-terminology" class="binding">Source Type Terminology</a><span title="null" class="binding"> (</span><a href="http://hl7.org/fhir/R5/terminologies.html#required" title="To be conformant, the concept in this element SHALL be from the specified value set." class="binding">required</a><span title="null" class="binding">)</span></td></tr>
    <tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white"><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck010.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_blank.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_datatype.gif" alt="." style="background-color: white; background-color: inherit" title="Data Type" class="hierarchy"/> <a href="StructureDefinition-pqcmc-component-substance-definitions.html#SubstanceDefinition.sourceMaterial.genus" title="The name, genus or genus and species of the organism from which the material is derived. [Source: SME Defined]
    Examples: human or Homo Sapiens, chicken, dog or canine, cow or bovine, rat or rattus.">genus</a><a name="SubstanceDefinition.sourceMaterial.genus"> </a></td><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><span style="padding-left: 3px; padding-right: 3px; color: white; background-color: red" title="This element must be supported">S</span></td><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><span style="opacity: 0.5">0</span><span style="opacity: 0.5">..</span><span style="opacity: 0.5">1</span></td><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="StructureDefinition-codeable-concept-text-only.html" title="CodeableConcept">CodeableConceptTextOnly</a></td><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">Source Organism Genus</td></tr>
    <tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7"><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck010.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_blank.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_datatype.gif" alt="." style="background-color: #F7F7F7; background-color: inherit" title="Data Type" class="hierarchy"/> <a href="StructureDefinition-pqcmc-component-substance-definitions.html#SubstanceDefinition.sourceMaterial.species" title="The name, genus or genus and species of the organism from which the material is derived. [Source: SME Defined]
    Examples: Examples: human or Homo Sapiens, chicken, dog or canine, cow or bovine, rat or rattus.">species</a><a name="SubstanceDefinition.sourceMaterial.species"> </a></td><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><span style="padding-left: 3px; padding-right: 3px; color: white; background-color: red" title="This element must be supported">S</span></td><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><span style="opacity: 0.5">0</span><span style="opacity: 0.5">..</span><span style="opacity: 0.5">1</span></td><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="StructureDefinition-codeable-concept-text-only.html" title="CodeableConcept">CodeableConceptTextOnly</a></td><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">Source Organism Species</td></tr>
    <tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white"><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck010.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_blank.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_datatype.gif" alt="." style="background-color: white; background-color: inherit" title="Data Type" class="hierarchy"/> <a href="StructureDefinition-pqcmc-component-substance-definitions.html#SubstanceDefinition.sourceMaterial.part" title="A fragment of the source organism. [Source: SME Defined]
    Examples: secretions, material from a specific organ, tissue or portion of the organism such as liver, pancreas, blood or from bark or seed of a plant.
    IDMP 11238 definition &amp; examples: Entity of anatomical origin of source material within an organism.
    Cartilage, Root and Stolon, whole plant is considered as a part, Aerial part of the plant, Leaf, Tuberous Root, whole animal">part</a><a name="SubstanceDefinition.sourceMaterial.part"> </a></td><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><span style="padding-left: 3px; padding-right: 3px; color: white; background-color: red" title="This element must be supported">S</span></td><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><span style="opacity: 0.5">0</span><span style="opacity: 0.5">..</span><span style="opacity: 0.5">1</span></td><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="StructureDefinition-codeable-concept-text-only.html" title="CodeableConcept">CodeableConceptTextOnly</a></td><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">Source Organism Part</td></tr>
    <tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7"><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck000.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_blank.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin_end.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_element.gif" alt="." style="background-color: #F7F7F7; background-color: inherit" title="Element" class="hierarchy"/> <a href="StructureDefinition-pqcmc-component-substance-definitions.html#SubstanceDefinition.sourceMaterial.countryOfOrigin" title="The name of the country where the organism was reared. [Source: SME Defined]">countryOfOrigin</a><a name="SubstanceDefinition.sourceMaterial.countryOfOrigin"> </a></td><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><span style="padding-left: 3px; padding-right: 3px; color: white; background-color: red" title="This element must be supported">S</span></td><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><span style="opacity: 0.5">0</span>..1</td><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a style="opacity: 0.5; opacity: 0.5" href="http://hl7.org/fhir/R5/datatypes.html#CodeableConcept">CodeableConcept</a></td><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">Source Organism Country of Origin<br class="binding"/><span style="font-weight:bold" title="null" class="binding">Binding: </span><a href="ValueSet-pqcmc-genc-and-iso-intersect.html" title="http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-genc-and-iso-intersect" class="binding">GENC and ISO 3166 Intersection</a><span title="null" class="binding"> (</span><a href="http://hl7.org/fhir/R5/terminologies.html#required" title="To be conformant, the concept in this element SHALL be from the specified value set." class="binding">required</a><span title="null" class="binding">)</span></td></tr>
    <tr><td colspan="5" class="hierarchy"><br/><a href="https://build.fhir.org/ig/FHIR/ig-guidance/readingIgs.html#table-views" title="Legend for this format"><img src="data:image/png;base64, " alt="doco" style="background-color: inherit"/> Documentation for this format</a></td></tr></table></div>
      </text>
      <extension
                 url="http://hl7.org/fhir/StructureDefinition/structuredefinition-wg">
        <valueCode value="brr"/>
      </extension>
      <extension
                 url="http://hl7.org/fhir/StructureDefinition/structuredefinition-fmm">
        <valueInteger value="2">
          <extension
                     url="http://hl7.org/fhir/StructureDefinition/structuredefinition-conformance-derivedFrom">
            <valueCanonical
                            value="http://hl7.org/fhir/us/pq-cmc-fda/ImplementationGuide/hl7.fhir.us.pq-cmc-fda"/>
          </extension>
        </valueInteger>
      </extension>
      <extension
                 url="http://hl7.org/fhir/StructureDefinition/structuredefinition-standards-status">
        <valueCode value="trial-use">
          <extension
                     url="http://hl7.org/fhir/StructureDefinition/structuredefinition-conformance-derivedFrom">
            <valueCanonical
                            value="http://hl7.org/fhir/us/pq-cmc-fda/ImplementationGuide/hl7.fhir.us.pq-cmc-fda"/>
          </extension>
        </valueCode>
      </extension>
      <url
           value="http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pqcmc-component-substance"/>
      <identifier>
        <system value="urn:ietf:rfc:3986"/>
        <value value="urn:oid:2.16.840.1.113883.4.642.40.36.42.22"/>
      </identifier>
      <version value="2.0.0"/>
      <name value="ComponentSubstance"/>
      <title value="Component Substance"/>
      <status value="active"/>
      <date value="2025-07-03T13:07:08+00:00"/>
      <publisher value="HL7 International / Biomedical Research and Regulation"/>
      <contact>
        <name value="HL7 International / Biomedical Research and Regulation"/>
        <telecom>
          <system value="url"/>
          <value value="http://www.hl7.org/Special/committees/rcrim"/>
        </telecom>
        <telecom>
          <system value="email"/>
          <value value="brr@lists.HL7.org"/>
        </telecom>
      </contact>
      <description
                   value="Any raw material intended for use in the manufacture of a drug substance, or any ingredient intended for use in the manufacture of a drug product including those that may not appear in such drug product."/>
      <jurisdiction>
        <coding>
          <system value="urn:iso:std:iso:3166"/>
          <code value="US"/>
          <display value="United States of America"/>
        </coding>
      </jurisdiction>
      <fhirVersion value="5.0.0"/>
      <mapping>
        <identity value="w5"/>
        <uri value="http://hl7.org/fhir/fivews"/>
        <name value="FiveWs Pattern Mapping"/>
      </mapping>
      <mapping>
        <identity value="idmp-substance"/>
        <uri value="https://www.iso.org/obp/ui/#iso:std:iso:11238"/>
        <name value="IDMP Mapping (Substance)"/>
      </mapping>
      <mapping>
        <identity value="rim"/>
        <uri value="http://hl7.org/v3"/>
        <name value="RIM Mapping"/>
      </mapping>
      <kind value="resource"/>
      <abstract value="false"/>
      <type value="SubstanceDefinition"/>
      <baseDefinition
                      value="http://hl7.org/fhir/StructureDefinition/SubstanceDefinition"/>
      <derivation value="constraint"/>
      <snapshot>
        <extension
                   url="http://hl7.org/fhir/tools/StructureDefinition/snapshot-base-version">
          <valueString value="5.0.0"/>
        </extension>
        <element id="SubstanceDefinition">
          <path value="SubstanceDefinition"/>
          <short
                 value="The detailed description of a substance, typically at a level beyond what is used for prescribing"/>
          <definition
                      value="The detailed description of a substance, typically at a level beyond what is used for prescribing."/>
          <min value="0"/>
          <max value="*"/>
          <base>
            <path value="SubstanceDefinition"/>
            <min value="0"/>
            <max value="*"/>
          </base>
          <constraint>
            <key value="dom-2"/>
            <severity value="error"/>
            <human
                   value="If the resource is contained in another resource, it SHALL NOT contain nested Resources"/>
            <expression value="contained.contained.empty()"/>
            <source
                    value="http://hl7.org/fhir/StructureDefinition/DomainResource"/>
          </constraint>
          <constraint>
            <key value="dom-3"/>
            <severity value="error"/>
            <human
                   value="If the resource is contained in another resource, it SHALL be referred to from elsewhere in the resource or SHALL refer to the containing resource"/>
            <expression
                        value="contained.where((('#'+id in (%resource.descendants().reference | %resource.descendants().ofType(canonical) | %resource.descendants().ofType(uri) | %resource.descendants().ofType(url))) or descendants().where(reference = '#').exists() or descendants().where(ofType(canonical) = '#').exists() or descendants().where(ofType(canonical) = '#').exists()).not()).trace('unmatched', id).empty()"/>
            <source
                    value="http://hl7.org/fhir/StructureDefinition/DomainResource"/>
          </constraint>
          <constraint>
            <key value="dom-4"/>
            <severity value="error"/>
            <human
                   value="If a resource is contained in another resource, it SHALL NOT have a meta.versionId or a meta.lastUpdated"/>
            <expression
                        value="contained.meta.versionId.empty() and contained.meta.lastUpdated.empty()"/>
            <source
                    value="http://hl7.org/fhir/StructureDefinition/DomainResource"/>
          </constraint>
          <constraint>
            <key value="dom-5"/>
            <severity value="error"/>
            <human
                   value="If a resource is contained in another resource, it SHALL NOT have a security label"/>
            <expression value="contained.meta.security.empty()"/>
            <source
                    value="http://hl7.org/fhir/StructureDefinition/DomainResource"/>
          </constraint>
          <constraint>
            <extension
                       url="http://hl7.org/fhir/StructureDefinition/elementdefinition-bestpractice">
              <valueBoolean value="true"/>
            </extension>
            <extension
                       url="http://hl7.org/fhir/StructureDefinition/elementdefinition-bestpractice-explanation">
              <valueMarkdown
                             value="When a resource has no narrative, only systems that fully understand the data can display the resource to a human safely. Including a human readable representation in the resource makes for a much more robust eco-system and cheaper handling of resources by intermediary systems. Some ecosystems restrict distribution of resources to only those systems that do fully understand the resources, and as a consequence implementers may believe that the narrative is superfluous. However experience shows that such eco-systems often open up to new participants over time."/>
            </extension>
            <key value="dom-6"/>
            <severity value="warning"/>
            <human
                   value="A resource should have narrative for robust management"/>
            <expression value="text.`div`.exists()"/>
            <source
                    value="http://hl7.org/fhir/StructureDefinition/DomainResource"/>
          </constraint>
          <constraint>
            <key value="cmc-when-unii-required"/>
            <severity value="error"/>
            <human
                   value="A UNII is required in code for any of these categories: 'Chemical', 'Mixture', 'Nucleic Acids','Polymer'. A UniProt code is required for any of these categories: 'Protein'"/>
            <expression
                        value="(classification.coding.where(system = 'http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl' and (code in ('C48807' | 'C45305' | 'C706' | 'C48803'))).exists()
    implies code.where(
      code.coding.exists(system = 'http://fdasis.nlm.nih.gov')
    ).exists())
     and (classification.coding.where(
      system = 'http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl' and
      code = 'C17021'
    ).exists() implies code.where(
      code.coding.exists(system = 'http://terminology.hl7.org/NamingSystem/UniProt')
    ).exists())"/>
            <source
                    value="http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pqcmc-component-substance"/>
          </constraint>
          <constraint>
            <key value="cmc-name-isbt"/>
            <severity value="error"/>
            <human value="Name.type ISBT 128 required for blood products."/>
            <expression
                        value="classification.where(coding.where(code = '8' and system = 'http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl').exists()).exists() implies name.type.coding.exists(code = '226' and system = 'http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl')"/>
            <source
                    value="http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pqcmc-component-substance"/>
          </constraint>
          <constraint>
            <key value="cmc-source-material"/>
            <severity value="error"/>
            <human
                   value="IF raw material source type equals Microbial, Animal, Plant, Insect or Human THEN the 4 source related attributes are required and the manufacturer and supplier information is highly desirable."/>
            <expression
                        value="sourceMaterial.type.coding.where(system = 'http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl' and (code in 'C14182' | 'C14225' | 'C14227' | 'C14329' | 'C14258')).exists()
    implies (sourceMaterial.genus.exists() and  sourceMaterial.species.exists() and sourceMaterial.part.exists() and sourceMaterial.countryOfOrigin.exists())"/>
            <source
                    value="http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pqcmc-component-substance"/>
          </constraint>
          <mustSupport value="false"/>
          <isModifier value="false"/>
          <isSummary value="false"/>
          <mapping>
            <identity value="rim"/>
            <map value="Entity, Role, or Act"/>
          </mapping>
          <mapping>
            <identity value="w5"/>
            <map value="administrative.medication"/>
          </mapping>
          <mapping>
            <identity value="idmp-substance"/>
            <map
                 value="Substance (and derived classes: Chemical, Polymer, Protein, Nucleic_Acid, Structurally_Diverse)"/>
          </mapping>
        </element>
        <element id="SubstanceDefinition.id">
          <path value="SubstanceDefinition.id"/>
          <short value="Logical id of this artifact"/>
          <definition
                      value="The logical id of the resource, as used in the URL for the resource. Once assigned, this value never changes."/>
          <comment
                   value="Within the context of the FHIR RESTful interactions, the resource has an id except for cases like the create and conditional update. Otherwise, the use of the resouce id depends on the given use case."/>
          <min value="0"/>
          <max value="1"/>
          <base>
            <path value="Resource.id"/>
            <min value="0"/>
            <max value="1"/>
          </base>
          <type>
            <extension
                       url="http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type">
              <valueUrl value="id"/>
            </extension>
            <code value="http://hl7.org/fhirpath/System.String"/>
          </type>
          <mustSupport value="false"/>
          <isModifier value="false"/>
          <isSummary value="true"/>
        </element>
        <element id="SubstanceDefinition.meta">
          <path value="SubstanceDefinition.meta"/>
          <short value="Metadata about the resource"/>
          <definition
                      value="The metadata about the resource. This is content that is maintained by the infrastructure. Changes to the content might not always be associated with version changes to the resource."/>
          <min value="0"/>
          <max value="1"/>
          <base>
            <path value="Resource.meta"/>
            <min value="0"/>
            <max value="1"/>
          </base>
          <type>
            <code value="Meta"/>
          </type>
          <constraint>
            <key value="ele-1"/>
            <severity value="error"/>
            <human value="All FHIR elements must have a @value or children"/>
            <expression
                        value="hasValue() or (children().count() &gt; id.count())"/>
            <source value="http://hl7.org/fhir/StructureDefinition/Element"/>
          </constraint>
          <mustSupport value="false"/>
          <isModifier value="false"/>
          <isSummary value="true"/>
        </element>
        <element id="SubstanceDefinition.implicitRules">
          <path value="SubstanceDefinition.implicitRules"/>
          <short value="A set of rules under which this content was created"/>
          <definition
                      value="A reference to a set of rules that were followed when the resource was constructed, and which must be understood when processing the content. Often, this is a reference to an implementation guide that defines the special rules along with other profiles etc."/>
          <comment
                   value="Asserting this rule set restricts the content to be only understood by a limited set of trading partners. This inherently limits the usefulness of the data in the long term. However, the existing health eco-system is highly fractured, and not yet ready to define, collect, and exchange data in a generally computable sense. Wherever possible, implementers and/or specification writers should avoid using this element. Often, when used, the URL is a reference to an implementation guide that defines these special rules as part of its narrative along with other profiles, value sets, etc."/>
          <min value="0"/>
          <max value="1"/>
          <base>
            <path value="Resource.implicitRules"/>
            <min value="0"/>
            <max value="1"/>
          </base>
          <type>
            <code value="uri"/>
          </type>
          <constraint>
            <key value="ele-1"/>
            <severity value="error"/>
            <human value="All FHIR elements must have a @value or children"/>
            <expression
                        value="hasValue() or (children().count() &gt; id.count())"/>
            <source value="http://hl7.org/fhir/StructureDefinition/Element"/>
          </constraint>
          <mustSupport value="false"/>
          <isModifier value="true"/>
          <isModifierReason
                            value="This element is labeled as a modifier because the implicit rules may provide additional knowledge about the resource that modifies its meaning or interpretation"/>
          <isSummary value="true"/>
        </element>
        <element id="SubstanceDefinition.language">
          <path value="SubstanceDefinition.language"/>
          <short value="Language of the resource content"/>
          <definition
                      value="The base language in which the resource is written."/>
          <comment
                   value="Language is provided to support indexing and accessibility (typically, services such as text to speech use the language tag). The html language tag in the narrative applies  to the narrative. The language tag on the resource may be used to specify the language of other presentations generated from the data in the resource. Not all the content has to be in the base language. The Resource.language should not be assumed to apply to the narrative automatically. If a language is specified, it should it also be specified on the div element in the html (see rules in HTML5 for information about the relationship between xml:lang and the html lang attribute)."/>
          <min value="0"/>
          <max value="1"/>
          <base>
            <path value="Resource.language"/>
            <min value="0"/>
            <max value="1"/>
          </base>
          <type>
            <code value="code"/>
          </type>
          <constraint>
            <key value="ele-1"/>
            <severity value="error"/>
            <human value="All FHIR elements must have a @value or children"/>
            <expression
                        value="hasValue() or (children().count() &gt; id.count())"/>
            <source value="http://hl7.org/fhir/StructureDefinition/Element"/>
          </constraint>
          <mustSupport value="false"/>
          <isModifier value="false"/>
          <isSummary value="false"/>
          <binding>
            <extension
                       url="http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName">
              <valueString value="Language"/>
            </extension>
            <strength value="required"/>
            <description value="IETF language tag for a human language"/>
            <valueSet value="http://hl7.org/fhir/ValueSet/all-languages|5.0.0"/>
            <additional>
              <purpose value="starter"/>
              <valueSet value="http://hl7.org/fhir/ValueSet/languages"/>
            </additional>
          </binding>
        </element>
        <element id="SubstanceDefinition.text">
          <path value="SubstanceDefinition.text"/>
          <short value="Text summary of the resource, for human interpretation"/>
          <definition
                      value="A human-readable narrative that contains a summary of the resource and can be used to represent the content of the resource to a human. The narrative need not encode all the structured data, but is required to contain sufficient detail to make it &quot;clinically safe&quot; for a human to just read the narrative. Resource definitions may define what content should be represented in the narrative to ensure clinical safety."/>
          <comment
                   value="Contained resources do not have a narrative. Resources that are not contained SHOULD have a narrative. In some cases, a resource may only have text with little or no additional discrete data (as long as all minOccurs=1 elements are satisfied).  This may be necessary for data from legacy systems where information is captured as a &quot;text blob&quot; or where text is additionally entered raw or narrated and encoded information is added later."/>
          <alias value="narrative"/>
          <alias value="html"/>
          <alias value="xhtml"/>
          <alias value="display"/>
          <min value="0"/>
          <max value="1"/>
          <base>
            <path value="DomainResource.text"/>
            <min value="0"/>
            <max value="1"/>
          </base>
          <type>
            <code value="Narrative"/>
          </type>
          <condition value="dom-6"/>
          <constraint>
            <key value="ele-1"/>
            <severity value="error"/>
            <human value="All FHIR elements must have a @value or children"/>
            <expression
                        value="hasValue() or (children().count() &gt; id.count())"/>
            <source value="http://hl7.org/fhir/StructureDefinition/Element"/>
          </constraint>
          <mustSupport value="false"/>
          <isModifier value="false"/>
          <isSummary value="false"/>
          <mapping>
            <identity value="rim"/>
            <map value="Act.text?"/>
          </mapping>
        </element>
        <element id="SubstanceDefinition.contained">
          <path value="SubstanceDefinition.contained"/>
          <short value="Contained, inline Resources"/>
          <definition
                      value="These resources do not have an independent existence apart from the resource that contains them - they cannot be identified independently, nor can they have their own independent transaction scope. This is allowed to be a Parameters resource if and only if it is referenced by a resource that provides context/meaning."/>
          <comment
                   value="This should never be done when the content can be identified properly, as once identification is lost, it is extremely difficult (and context dependent) to restore it again. Contained resources may have profiles and tags in their meta elements, but SHALL NOT have security labels."/>
          <alias value="inline resources"/>
          <alias value="anonymous resources"/>
          <alias value="contained resources"/>
          <min value="0"/>
          <max value="*"/>
          <base>
            <path value="DomainResource.contained"/>
            <min value="0"/>
            <max value="*"/>
          </base>
          <type>
            <code value="Resource"/>
          </type>
          <condition value="dom-2"/>
          <condition value="dom-4"/>
          <condition value="dom-3"/>
          <condition value="dom-5"/>
          <mustSupport value="false"/>
          <isModifier value="false"/>
          <isSummary value="false"/>
          <mapping>
            <identity value="rim"/>
            <map value="N/A"/>
          </mapping>
        </element>
        <element id="SubstanceDefinition.extension">
          <path value="SubstanceDefinition.extension"/>
          <short value="Additional content defined by implementations"/>
          <definition
                      value="May be used to represent additional information that is not part of the basic definition of the resource. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension."/>
          <comment
                   value="There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions.  The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone."/>
          <alias value="extensions"/>
          <alias value="user content"/>
          <min value="0"/>
          <max value="*"/>
          <base>
            <path value="DomainResource.extension"/>
            <min value="0"/>
            <max value="*"/>
          </base>
          <type>
            <code value="Extension"/>
          </type>
          <constraint>
            <key value="ele-1"/>
            <severity value="error"/>
            <human value="All FHIR elements must have a @value or children"/>
            <expression
                        value="hasValue() or (children().count() &gt; id.count())"/>
            <source value="http://hl7.org/fhir/StructureDefinition/Element"/>
          </constraint>
          <constraint>
            <key value="ext-1"/>
            <severity value="error"/>
            <human value="Must have either extensions or value[x], not both"/>
            <expression value="extension.exists() != value.exists()"/>
            <source value="http://hl7.org/fhir/StructureDefinition/Extension"/>
          </constraint>
          <mustSupport value="false"/>
          <isModifier value="false"/>
          <isSummary value="false"/>
          <mapping>
            <identity value="rim"/>
            <map value="N/A"/>
          </mapping>
        </element>
        <element id="SubstanceDefinition.modifierExtension">
          <path value="SubstanceDefinition.modifierExtension"/>
          <short value="Extensions that cannot be ignored"/>
          <definition
                      value="May be used to represent additional information that is not part of the basic definition of the resource and that modifies the understanding of the element that contains it and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer is allowed to define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.

    Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself)."/>
          <comment
                   value="There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions.  The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone."/>
          <requirements
                        value="Modifier extensions allow for extensions that *cannot* be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored.  This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the [definition of modifier extensions](http://hl7.org/fhir/R5/extensibility.html#modifierExtension)."/>
          <alias value="extensions"/>
          <alias value="user content"/>
          <min value="0"/>
          <max value="*"/>
          <base>
            <path value="DomainResource.modifierExtension"/>
            <min value="0"/>
            <max value="*"/>
          </base>
          <type>
            <code value="Extension"/>
          </type>
          <constraint>
            <key value="ele-1"/>
            <severity value="error"/>
            <human value="All FHIR elements must have a @value or children"/>
            <expression
                        value="hasValue() or (children().count() &gt; id.count())"/>
            <source value="http://hl7.org/fhir/StructureDefinition/Element"/>
          </constraint>
          <constraint>
            <key value="ext-1"/>
            <severity value="error"/>
            <human value="Must have either extensions or value[x], not both"/>
            <expression value="extension.exists() != value.exists()"/>
            <source value="http://hl7.org/fhir/StructureDefinition/Extension"/>
          </constraint>
          <mustSupport value="false"/>
          <isModifier value="true"/>
          <isModifierReason
                            value="Modifier extensions are expected to modify the meaning or interpretation of the resource that contains them"/>
          <isSummary value="true"/>
          <mapping>
            <identity value="rim"/>
            <map value="N/A"/>
          </mapping>
        </element>
        <element id="SubstanceDefinition.identifier">
          <path value="SubstanceDefinition.identifier"/>
          <short value="optional user designated identifier"/>
          <definition value="Identifier by which this substance is known."/>
          <min value="0"/>
          <max value="1"/>
          <base>
            <path value="SubstanceDefinition.identifier"/>
            <min value="0"/>
            <max value="*"/>
          </base>
          <type>
            <code value="Identifier"/>
          </type>
          <constraint>
            <key value="ele-1"/>
            <severity value="error"/>
            <human value="All FHIR elements must have a @value or children"/>
            <expression
                        value="hasValue() or (children().count() &gt; id.count())"/>
            <source value="http://hl7.org/fhir/StructureDefinition/Element"/>
          </constraint>
          <mustSupport value="false"/>
          <isModifier value="false"/>
          <isSummary value="true"/>
          <mapping>
            <identity value="idmp-substance"/>
            <map value="Substance.Substance_Id"/>
          </mapping>
        </element>
        <element id="SubstanceDefinition.version">
          <path value="SubstanceDefinition.version"/>
          <short value="A business level version identifier of the substance"/>
          <definition
                      value="A business level version identifier of the substance."/>
          <min value="0"/>
          <max value="1"/>
          <base>
            <path value="SubstanceDefinition.version"/>
            <min value="0"/>
            <max value="1"/>
          </base>
          <type>
            <code value="string"/>
          </type>
          <constraint>
            <key value="ele-1"/>
            <severity value="error"/>
            <human value="All FHIR elements must have a @value or children"/>
            <expression
                        value="hasValue() or (children().count() &gt; id.count())"/>
            <source value="http://hl7.org/fhir/StructureDefinition/Element"/>
          </constraint>
          <mustSupport value="false"/>
          <isModifier value="false"/>
          <isSummary value="true"/>
          <mapping>
            <identity value="idmp-substance"/>
            <map value="Version.Version_Number"/>
          </mapping>
        </element>
        <element id="SubstanceDefinition.status">
          <path value="SubstanceDefinition.status"/>
          <short
                 value="Status of substance within the catalogue e.g. active, retired"/>
          <definition
                      value="Status of substance within the catalogue e.g. active, retired."/>
          <min value="0"/>
          <max value="1"/>
          <base>
            <path value="SubstanceDefinition.status"/>
            <min value="0"/>
            <max value="1"/>
          </base>
          <type>
            <code value="CodeableConcept"/>
          </type>
          <constraint>
            <key value="ele-1"/>
            <severity value="error"/>
            <human value="All FHIR elements must have a @value or children"/>
            <expression
                        value="hasValue() or (children().count() &gt; id.count())"/>
            <source value="http://hl7.org/fhir/StructureDefinition/Element"/>
          </constraint>
          <mustSupport value="false"/>
          <isModifier value="false"/>
          <isSummary value="true"/>
          <binding>
            <extension
                       url="http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName">
              <valueString value="PublicationStatus"/>
            </extension>
            <strength value="preferred"/>
            <description value="The lifecycle status of an artifact."/>
            <valueSet value="http://hl7.org/fhir/ValueSet/publication-status"/>
          </binding>
          <mapping>
            <identity value="idmp-substance"/>
            <map value="n/a"/>
          </mapping>
        </element>
        <element id="SubstanceDefinition.classification">
          <path value="SubstanceDefinition.classification"/>
          <short value="Substance Type"/>
          <definition
                      value="A controlled vocabulary as provided by the prEN ISO 11238 - Health informatics identification of medicinal products - Structures and controlled vocabularies for drug substances to group drug substances at a relatively high level acording to the Substance and the Substance Preparation Model.
    [Source: Adapted from 'Logical model of the classification and identification of pharmaceutical and medicinal Products', HL7]"/>
          <min value="1"/>
          <max value="1"/>
          <base>
            <path value="SubstanceDefinition.classification"/>
            <min value="0"/>
            <max value="*"/>
          </base>
          <type>
            <code value="CodeableConcept"/>
          </type>
          <constraint>
            <key value="ele-1"/>
            <severity value="error"/>
            <human value="All FHIR elements must have a @value or children"/>
            <expression
                        value="hasValue() or (children().count() &gt; id.count())"/>
            <source value="http://hl7.org/fhir/StructureDefinition/Element"/>
          </constraint>
          <mustSupport value="true"/>
          <isModifier value="false"/>
          <isSummary value="true"/>
          <binding>
            <strength value="required"/>
            <valueSet
                      value="http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/substance-classification"/>
          </binding>
          <mapping>
            <identity value="idmp-substance"/>
            <map
                 value="Substance_Classification.Substance_Classification and Substance_classification.Substance_Classification_Subtype"/>
          </mapping>
        </element>
        <element id="SubstanceDefinition.domain">
          <path value="SubstanceDefinition.domain"/>
          <short value="If the substance applies to human or veterinary use"/>
          <definition
                      value="If the substance applies to human or veterinary use."/>
          <min value="0"/>
          <max value="1"/>
          <base>
            <path value="SubstanceDefinition.domain"/>
            <min value="0"/>
            <max value="1"/>
          </base>
          <type>
            <code value="CodeableConcept"/>
          </type>
          <constraint>
            <key value="ele-1"/>
            <severity value="error"/>
            <human value="All FHIR elements must have a @value or children"/>
            <expression
                        value="hasValue() or (children().count() &gt; id.count())"/>
            <source value="http://hl7.org/fhir/StructureDefinition/Element"/>
          </constraint>
          <mustSupport value="false"/>
          <isModifier value="false"/>
          <isSummary value="true"/>
          <binding>
            <extension
                       url="http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName">
              <valueString value="MedicinalProductType"/>
            </extension>
            <strength value="example"/>
            <description
                         value="Applicable domain for this product (e.g. human, veterinary)."/>
            <valueSet
                      value="http://hl7.org/fhir/ValueSet/medicinal-product-domain"/>
          </binding>
          <mapping>
            <identity value="idmp-substance"/>
            <map
                 value="Substance_Classification.Substance_Classification (and Code and Type) and Substance_Classification.Substance_Classification_Subtype"/>
          </mapping>
        </element>
        <element id="SubstanceDefinition.grade">
          <path value="SubstanceDefinition.grade"/>
          <short value="Quality Standard"/>
          <definition
                      value="The established benchmark to which the component complies. [Source: SME Defined]
    Examples: USP/NF, EP, Company Standard"/>
          <min value="1"/>
          <max value="*"/>
          <base>
            <path value="SubstanceDefinition.grade"/>
            <min value="0"/>
            <max value="*"/>
          </base>
          <type>
            <code value="CodeableConcept"/>
          </type>
          <constraint>
            <key value="ele-1"/>
            <severity value="error"/>
            <human value="All FHIR elements must have a @value or children"/>
            <expression
                        value="hasValue() or (children().count() &gt; id.count())"/>
            <source value="http://hl7.org/fhir/StructureDefinition/Element"/>
          </constraint>
          <mustSupport value="false"/>
          <isModifier value="false"/>
          <isSummary value="true"/>
          <binding>
            <strength value="required"/>
            <valueSet
                      value="http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-quality-benchmark-terminology"/>
          </binding>
          <mapping>
            <identity value="idmp-substance"/>
            <map value="Substance_Specified_Substance_Group_3.Grade"/>
          </mapping>
        </element>
        <element id="SubstanceDefinition.description">
          <path value="SubstanceDefinition.description"/>
          <short value="Textual description of the substance"/>
          <definition value="Textual description of the substance."/>
          <min value="0"/>
          <max value="1"/>
          <base>
            <path value="SubstanceDefinition.description"/>
            <min value="0"/>
            <max value="1"/>
          </base>
          <type>
            <code value="markdown"/>
          </type>
          <constraint>
            <key value="ele-1"/>
            <severity value="error"/>
            <human value="All FHIR elements must have a @value or children"/>
            <expression
                        value="hasValue() or (children().count() &gt; id.count())"/>
            <source value="http://hl7.org/fhir/StructureDefinition/Element"/>
          </constraint>
          <mustSupport value="false"/>
          <isModifier value="false"/>
          <isSummary value="true"/>
          <mapping>
            <identity value="idmp-substance"/>
            <map value="Substance.Comment"/>
          </mapping>
        </element>
        <element id="SubstanceDefinition.informationSource">
          <path value="SubstanceDefinition.informationSource"/>
          <short value="Supporting literature"/>
          <definition value="Supporting literature."/>
          <min value="0"/>
          <max value="*"/>
          <base>
            <path value="SubstanceDefinition.informationSource"/>
            <min value="0"/>
            <max value="*"/>
          </base>
          <type>
            <code value="Reference"/>
            <targetProfile
                           value="http://hl7.org/fhir/StructureDefinition/Citation"/>
          </type>
          <constraint>
            <key value="ele-1"/>
            <severity value="error"/>
            <human value="All FHIR elements must have a @value or children"/>
            <expression
                        value="hasValue() or (children().count() &gt; id.count())"/>
            <source value="http://hl7.org/fhir/StructureDefinition/Element"/>
          </constraint>
          <mustSupport value="false"/>
          <isModifier value="false"/>
          <isSummary value="true"/>
          <mapping>
            <identity value="idmp-substance"/>
            <map value="Substance.Reference_Source"/>
          </mapping>
        </element>
        <element id="SubstanceDefinition.note">
          <path value="SubstanceDefinition.note"/>
          <short
                 value="Textual comment about the substance's catalogue or registry record"/>
          <definition
                      value="Textual comment about the substance's catalogue or registry record."/>
          <min value="0"/>
          <max value="*"/>
          <base>
            <path value="SubstanceDefinition.note"/>
            <min value="0"/>
            <max value="*"/>
          </base>
          <type>
            <code value="Annotation"/>
          </type>
          <constraint>
            <key value="ele-1"/>
            <severity value="error"/>
            <human value="All FHIR elements must have a @value or children"/>
            <expression
                        value="hasValue() or (children().count() &gt; id.count())"/>
            <source value="http://hl7.org/fhir/StructureDefinition/Element"/>
          </constraint>
          <mustSupport value="false"/>
          <isModifier value="false"/>
          <isSummary value="true"/>
          <mapping>
            <identity value="idmp-substance"/>
            <map value="n/a"/>
          </mapping>
        </element>
        <element id="SubstanceDefinition.manufacturer">
          <path value="SubstanceDefinition.manufacturer"/>
          <short
                 value="The entity that creates, makes, produces or fabricates the substance"/>
          <definition
                      value="The entity that creates, makes, produces or fabricates the substance. This is a set of potential manufacturers but is not necessarily comprehensive."/>
          <min value="0"/>
          <max value="1"/>
          <base>
            <path value="SubstanceDefinition.manufacturer"/>
            <min value="0"/>
            <max value="*"/>
          </base>
          <type>
            <code value="Reference"/>
            <profile
                     value="http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/literal-reference"/>
            <targetProfile
                           value="http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/cmc-organization"/>
            <aggregation value="bundled"/>
          </type>
          <constraint>
            <key value="ele-1"/>
            <severity value="error"/>
            <human value="All FHIR elements must have a @value or children"/>
            <expression
                        value="hasValue() or (children().count() &gt; id.count())"/>
            <source value="http://hl7.org/fhir/StructureDefinition/Element"/>
          </constraint>
          <mustSupport value="true"/>
          <isModifier value="false"/>
          <isSummary value="true"/>
          <mapping>
            <identity value="idmp-substance"/>
            <map value="n/a"/>
          </mapping>
        </element>
        <element id="SubstanceDefinition.supplier">
          <path value="SubstanceDefinition.supplier"/>
          <short
                 value="An entity that is the source for the substance. It may be different from the manufacturer"/>
          <definition
                      value="An entity that is the source for the substance. It may be different from the manufacturer. Supplier is synonymous to a distributor."/>
          <min value="0"/>
          <max value="1"/>
          <base>
            <path value="SubstanceDefinition.supplier"/>
            <min value="0"/>
            <max value="*"/>
          </base>
          <type>
            <code value="Reference"/>
            <profile
                     value="http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/literal-reference"/>
            <targetProfile
                           value="http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/cmc-organization"/>
            <aggregation value="bundled"/>
          </type>
          <constraint>
            <key value="ele-1"/>
            <severity value="error"/>
            <human value="All FHIR elements must have a @value or children"/>
            <expression
                        value="hasValue() or (children().count() &gt; id.count())"/>
            <source value="http://hl7.org/fhir/StructureDefinition/Element"/>
          </constraint>
          <mustSupport value="true"/>
          <isModifier value="false"/>
          <isSummary value="true"/>
          <mapping>
            <identity value="idmp-substance"/>
            <map value="n/a"/>
          </mapping>
        </element>
        <element id="SubstanceDefinition.moiety">
          <path value="SubstanceDefinition.moiety"/>
          <short value="Moiety, for structural modifications"/>
          <definition value="Moiety, for structural modifications."/>
          <min value="0"/>
          <max value="*"/>
          <base>
            <path value="SubstanceDefinition.moiety"/>
            <min value="0"/>
            <max value="*"/>
          </base>
          <type>
            <code value="BackboneElement"/>
          </type>
          <constraint>
            <key value="ele-1"/>
            <severity value="error"/>
            <human value="All FHIR elements must have a @value or children"/>
            <expression
                        value="hasValue() or (children().count() &gt; id.count())"/>
            <source value="http://hl7.org/fhir/StructureDefinition/Element"/>
          </constraint>
          <mustSupport value="false"/>
          <isModifier value="false"/>
          <isSummary value="true"/>
          <mapping>
            <identity value="idmp-substance"/>
            <map value="Substance.Moiety"/>
          </mapping>
        </element>
        <element id="SubstanceDefinition.moiety.id">
          <path value="SubstanceDefinition.moiety.id"/>
          <representation value="xmlAttr"/>
          <short value="Unique id for inter-element referencing"/>
          <definition
                      value="Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces."/>
          <min value="0"/>
          <max value="1"/>
          <base>
            <path value="Element.id"/>
            <min value="0"/>
            <max value="1"/>
          </base>
          <type>
            <extension
                       url="http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type">
              <valueUrl value="string"/>
            </extension>
            <code value="http://hl7.org/fhirpath/System.String"/>
          </type>
          <condition value="ele-1"/>
          <isModifier value="false"/>
          <isSummary value="false"/>
          <mapping>
            <identity value="rim"/>
            <map value="n/a"/>
          </mapping>
        </element>
        <element id="SubstanceDefinition.moiety.extension">
          <path value="SubstanceDefinition.moiety.extension"/>
          <short value="Additional content defined by implementations"/>
          <definition
                      value="May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension."/>
          <comment
                   value="There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions.  The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone."/>
          <alias value="extensions"/>
          <alias value="user content"/>
          <min value="0"/>
          <max value="*"/>
          <base>
            <path value="Element.extension"/>
            <min value="0"/>
            <max value="*"/>
          </base>
          <type>
            <code value="Extension"/>
          </type>
          <constraint>
            <key value="ele-1"/>
            <severity value="error"/>
            <human value="All FHIR elements must have a @value or children"/>
            <expression
                        value="hasValue() or (children().count() &gt; id.count())"/>
            <source value="http://hl7.org/fhir/StructureDefinition/Element"/>
          </constraint>
          <constraint>
            <key value="ext-1"/>
            <severity value="error"/>
            <human value="Must have either extensions or value[x], not both"/>
            <expression value="extension.exists() != value.exists()"/>
            <source value="http://hl7.org/fhir/StructureDefinition/Extension"/>
          </constraint>
          <isModifier value="false"/>
          <isSummary value="false"/>
          <mapping>
            <identity value="rim"/>
            <map value="n/a"/>
          </mapping>
        </element>
        <element id="SubstanceDefinition.moiety.modifierExtension">
          <path value="SubstanceDefinition.moiety.modifierExtension"/>
          <short value="Extensions that cannot be ignored even if unrecognized"/>
          <definition
                      value="May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.

    Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself)."/>
          <comment
                   value="There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions.  The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone."/>
          <requirements
                        value="Modifier extensions allow for extensions that *cannot* be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored.  This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the [definition of modifier extensions](http://hl7.org/fhir/R5/extensibility.html#modifierExtension)."/>
          <alias value="extensions"/>
          <alias value="user content"/>
          <alias value="modifiers"/>
          <min value="0"/>
          <max value="*"/>
          <base>
            <path value="BackboneElement.modifierExtension"/>
            <min value="0"/>
            <max value="*"/>
          </base>
          <type>
            <code value="Extension"/>
          </type>
          <constraint>
            <key value="ele-1"/>
            <severity value="error"/>
            <human value="All FHIR elements must have a @value or children"/>
            <expression
                        value="hasValue() or (children().count() &gt; id.count())"/>
            <source value="http://hl7.org/fhir/StructureDefinition/Element"/>
          </constraint>
          <constraint>
            <key value="ext-1"/>
            <severity value="error"/>
            <human value="Must have either extensions or value[x], not both"/>
            <expression value="extension.exists() != value.exists()"/>
            <source value="http://hl7.org/fhir/StructureDefinition/Extension"/>
          </constraint>
          <isModifier value="true"/>
          <isModifierReason
                            value="Modifier extensions are expected to modify the meaning or interpretation of the element that contains them"/>
          <isSummary value="true"/>
          <mapping>
            <identity value="rim"/>
            <map value="N/A"/>
          </mapping>
        </element>
        <element id="SubstanceDefinition.moiety.role">
          <path value="SubstanceDefinition.moiety.role"/>
          <short value="Role that the moiety is playing"/>
          <definition value="Role that the moiety is playing."/>
          <min value="0"/>
          <max value="1"/>
          <base>
            <path value="SubstanceDefinition.moiety.role"/>
            <min value="0"/>
            <max value="1"/>
          </base>
          <type>
            <code value="CodeableConcept"/>
          </type>
          <constraint>
            <key value="ele-1"/>
            <severity value="error"/>
            <human value="All FHIR elements must have a @value or children"/>
            <expression
                        value="hasValue() or (children().count() &gt; id.count())"/>
            <source value="http://hl7.org/fhir/StructureDefinition/Element"/>
          </constraint>
          <mustSupport value="false"/>
          <isModifier value="false"/>
          <isSummary value="true"/>
          <mapping>
            <identity value="idmp-substance"/>
            <map value="Moiety.Moiety_Role"/>
          </mapping>
        </element>
        <element id="SubstanceDefinition.moiety.identifier">
          <path value="SubstanceDefinition.moiety.identifier"/>
          <short value="Identifier by which this moiety substance is known"/>
          <definition
                      value="Identifier by which this moiety substance is known."/>
          <min value="0"/>
          <max value="1"/>
          <base>
            <path value="SubstanceDefinition.moiety.identifier"/>
            <min value="0"/>
            <max value="1"/>
          </base>
          <type>
            <code value="Identifier"/>
          </type>
          <constraint>
            <key value="ele-1"/>
            <severity value="error"/>
            <human value="All FHIR elements must have a @value or children"/>
            <expression
                        value="hasValue() or (children().count() &gt; id.count())"/>
            <source value="http://hl7.org/fhir/StructureDefinition/Element"/>
          </constraint>
          <mustSupport value="false"/>
          <isModifier value="false"/>
          <isSummary value="true"/>
          <mapping>
            <identity value="idmp-substance"/>
            <map value="Moiety.Moiety_Id"/>
          </mapping>
        </element>
        <element id="SubstanceDefinition.moiety.name">
          <path value="SubstanceDefinition.moiety.name"/>
          <short value="Textual name for this moiety substance"/>
          <definition value="Textual name for this moiety substance."/>
          <min value="0"/>
          <max value="1"/>
          <base>
            <path value="SubstanceDefinition.moiety.name"/>
            <min value="0"/>
            <max value="1"/>
          </base>
          <type>
            <code value="string"/>
          </type>
          <constraint>
            <key value="ele-1"/>
            <severity value="error"/>
            <human value="All FHIR elements must have a @value or children"/>
            <expression
                        value="hasValue() or (children().count() &gt; id.count())"/>
            <source value="http://hl7.org/fhir/StructureDefinition/Element"/>
          </constraint>
          <mustSupport value="false"/>
          <isModifier value="false"/>
          <isSummary value="true"/>
          <mapping>
            <identity value="idmp-substance"/>
            <map value="Moiety.Moiety_Name"/>
          </mapping>
        </element>
        <element id="SubstanceDefinition.moiety.stereochemistry">
          <path value="SubstanceDefinition.moiety.stereochemistry"/>
          <short value="Stereochemistry type"/>
          <definition value="Stereochemistry type."/>
          <min value="0"/>
          <max value="1"/>
          <base>
            <path value="SubstanceDefinition.moiety.stereochemistry"/>
            <min value="0"/>
            <max value="1"/>
          </base>
          <type>
            <code value="CodeableConcept"/>
          </type>
          <constraint>
            <key value="ele-1"/>
            <severity value="error"/>
            <human value="All FHIR elements must have a @value or children"/>
            <expression
                        value="hasValue() or (children().count() &gt; id.count())"/>
            <source value="http://hl7.org/fhir/StructureDefinition/Element"/>
          </constraint>
          <mustSupport value="false"/>
          <isModifier value="false"/>
          <isSummary value="true"/>
          <binding>
            <extension
                       url="http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName">
              <valueString value="SubstanceStereochemistry"/>
            </extension>
            <strength value="example"/>
            <description value="The optical rotation type of a substance."/>
            <valueSet
                      value="http://hl7.org/fhir/ValueSet/substance-stereochemistry"/>
          </binding>
          <mapping>
            <identity value="idmp-substance"/>
            <map value="Moiety.Stereochemistry"/>
          </mapping>
        </element>
        <element id="SubstanceDefinition.moiety.opticalActivity">
          <path value="SubstanceDefinition.moiety.opticalActivity"/>
          <short value="Optical activity type"/>
          <definition value="Optical activity type."/>
          <min value="0"/>
          <max value="1"/>
          <base>
            <path value="SubstanceDefinition.moiety.opticalActivity"/>
            <min value="0"/>
            <max value="1"/>
          </base>
          <type>
            <code value="CodeableConcept"/>
          </type>
          <constraint>
            <key value="ele-1"/>
            <severity value="error"/>
            <human value="All FHIR elements must have a @value or children"/>
            <expression
                        value="hasValue() or (children().count() &gt; id.count())"/>
            <source value="http://hl7.org/fhir/StructureDefinition/Element"/>
          </constraint>
          <mustSupport value="false"/>
          <isModifier value="false"/>
          <isSummary value="true"/>
          <binding>
            <extension
                       url="http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName">
              <valueString value="SubstanceOpticalActivity"/>
            </extension>
            <strength value="example"/>
            <description value="The optical rotation type of a substance."/>
            <valueSet
                      value="http://hl7.org/fhir/ValueSet/substance-optical-activity"/>
          </binding>
          <mapping>
            <identity value="idmp-substance"/>
            <map value="Moiety.Optical_Activity"/>
          </mapping>
        </element>
        <element id="SubstanceDefinition.moiety.molecularFormula">
          <path value="SubstanceDefinition.moiety.molecularFormula"/>
          <short
                 value="Molecular formula for this moiety (e.g. with the Hill system)"/>
          <definition
                      value="Molecular formula for this moiety of this substance, typically using the Hill system."/>
          <min value="0"/>
          <max value="1"/>
          <base>
            <path value="SubstanceDefinition.moiety.molecularFormula"/>
            <min value="0"/>
            <max value="1"/>
          </base>
          <type>
            <code value="string"/>
          </type>
          <constraint>
            <key value="ele-1"/>
            <severity value="error"/>
            <human value="All FHIR elements must have a @value or children"/>
            <expression
                        value="hasValue() or (children().count() &gt; id.count())"/>
            <source value="http://hl7.org/fhir/StructureDefinition/Element"/>
          </constraint>
          <mustSupport value="false"/>
          <isModifier value="false"/>
          <isSummary value="true"/>
          <mapping>
            <identity value="idmp-substance"/>
            <map value="Moiety.Molecular_Formula"/>
          </mapping>
        </element>
        <element id="SubstanceDefinition.moiety.amount[x]">
          <path value="SubstanceDefinition.moiety.amount[x]"/>
          <short value="Quantitative value for this moiety"/>
          <definition value="Quantitative value for this moiety."/>
          <min value="0"/>
          <max value="1"/>
          <base>
            <path value="SubstanceDefinition.moiety.amount[x]"/>
            <min value="0"/>
            <max value="1"/>
          </base>
          <type>
            <code value="Quantity"/>
          </type>
          <type>
            <code value="string"/>
          </type>
          <constraint>
            <key value="ele-1"/>
            <severity value="error"/>
            <human value="All FHIR elements must have a @value or children"/>
            <expression
                        value="hasValue() or (children().count() &gt; id.count())"/>
            <source value="http://hl7.org/fhir/StructureDefinition/Element"/>
          </constraint>
          <mustSupport value="false"/>
          <isModifier value="false"/>
          <isSummary value="true"/>
          <mapping>
            <identity value="idmp-substance"/>
            <map value="Moiety.Amount"/>
          </mapping>
        </element>
        <element id="SubstanceDefinition.moiety.measurementType">
          <path value="SubstanceDefinition.moiety.measurementType"/>
          <short value="The measurement type of the quantitative value"/>
          <definition
                      value="The measurement type of the quantitative value. In capturing the actual relative amounts of substances or molecular fragments it may be necessary to indicate whether the amount refers to, for example, a mole ratio or weight ratio."/>
          <min value="0"/>
          <max value="1"/>
          <base>
            <path value="SubstanceDefinition.moiety.measurementType"/>
            <min value="0"/>
            <max value="1"/>
          </base>
          <type>
            <code value="CodeableConcept"/>
          </type>
          <constraint>
            <key value="ele-1"/>
            <severity value="error"/>
            <human value="All FHIR elements must have a @value or children"/>
            <expression
                        value="hasValue() or (children().count() &gt; id.count())"/>
            <source value="http://hl7.org/fhir/StructureDefinition/Element"/>
          </constraint>
          <mustSupport value="false"/>
          <isModifier value="false"/>
          <isSummary value="true"/>
          <binding>
            <extension
                       url="http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName">
              <valueString value="SubstanceAmountType"/>
            </extension>
            <strength value="example"/>
            <description value="The relationship between two substance types."/>
            <valueSet value="http://hl7.org/fhir/ValueSet/substance-amount-type"/>
          </binding>
          <mapping>
            <identity value="idmp-substance"/>
            <map value="Amount.Amount_Type"/>
          </mapping>
        </element>
        <element id="SubstanceDefinition.characterization">
          <path value="SubstanceDefinition.characterization"/>
          <short value="General specifications for this substance"/>
          <definition value="General specifications for this substance."/>
          <min value="0"/>
          <max value="*"/>
          <base>
            <path value="SubstanceDefinition.characterization"/>
            <min value="0"/>
            <max value="*"/>
          </base>
          <type>
            <code value="BackboneElement"/>
          </type>
          <constraint>
            <key value="ele-1"/>
            <severity value="error"/>
            <human value="All FHIR elements must have a @value or children"/>
            <expression
                        value="hasValue() or (children().count() &gt; id.count())"/>
            <source value="http://hl7.org/fhir/StructureDefinition/Element"/>
          </constraint>
          <mustSupport value="false"/>
          <isModifier value="false"/>
          <isSummary value="true"/>
          <mapping>
            <identity value="idmp-substance"/>
            <map value="n/a"/>
          </mapping>
        </element>
        <element id="SubstanceDefinition.characterization.id">
          <path value="SubstanceDefinition.characterization.id"/>
          <representation value="xmlAttr"/>
          <short value="Unique id for inter-element referencing"/>
          <definition
                      value="Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces."/>
          <min value="0"/>
          <max value="1"/>
          <base>
            <path value="Element.id"/>
            <min value="0"/>
            <max value="1"/>
          </base>
          <type>
            <extension
                       url="http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type">
              <valueUrl value="string"/>
            </extension>
            <code value="http://hl7.org/fhirpath/System.String"/>
          </type>
          <condition value="ele-1"/>
          <isModifier value="false"/>
          <isSummary value="false"/>
          <mapping>
            <identity value="rim"/>
            <map value="n/a"/>
          </mapping>
        </element>
        <element id="SubstanceDefinition.characterization.extension">
          <path value="SubstanceDefinition.characterization.extension"/>
          <short value="Additional content defined by implementations"/>
          <definition
                      value="May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension."/>
          <comment
                   value="There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions.  The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone."/>
          <alias value="extensions"/>
          <alias value="user content"/>
          <min value="0"/>
          <max value="*"/>
          <base>
            <path value="Element.extension"/>
            <min value="0"/>
            <max value="*"/>
          </base>
          <type>
            <code value="Extension"/>
          </type>
          <constraint>
            <key value="ele-1"/>
            <severity value="error"/>
            <human value="All FHIR elements must have a @value or children"/>
            <expression
                        value="hasValue() or (children().count() &gt; id.count())"/>
            <source value="http://hl7.org/fhir/StructureDefinition/Element"/>
          </constraint>
          <constraint>
            <key value="ext-1"/>
            <severity value="error"/>
            <human value="Must have either extensions or value[x], not both"/>
            <expression value="extension.exists() != value.exists()"/>
            <source value="http://hl7.org/fhir/StructureDefinition/Extension"/>
          </constraint>
          <isModifier value="false"/>
          <isSummary value="false"/>
          <mapping>
            <identity value="rim"/>
            <map value="n/a"/>
          </mapping>
        </element>
        <element id="SubstanceDefinition.characterization.modifierExtension">
          <path value="SubstanceDefinition.characterization.modifierExtension"/>
          <short value="Extensions that cannot be ignored even if unrecognized"/>
          <definition
                      value="May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.

    Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself)."/>
          <comment
                   value="There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions.  The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone."/>
          <requirements
                        value="Modifier extensions allow for extensions that *cannot* be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored.  This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the [definition of modifier extensions](http://hl7.org/fhir/R5/extensibility.html#modifierExtension)."/>
          <alias value="extensions"/>
          <alias value="user content"/>
          <alias value="modifiers"/>
          <min value="0"/>
          <max value="*"/>
          <base>
            <path value="BackboneElement.modifierExtension"/>
            <min value="0"/>
            <max value="*"/>
          </base>
          <type>
            <code value="Extension"/>
          </type>
          <constraint>
            <key value="ele-1"/>
            <severity value="error"/>
            <human value="All FHIR elements must have a @value or children"/>
            <expression
                        value="hasValue() or (children().count() &gt; id.count())"/>
            <source value="http://hl7.org/fhir/StructureDefinition/Element"/>
          </constraint>
          <constraint>
            <key value="ext-1"/>
            <severity value="error"/>
            <human value="Must have either extensions or value[x], not both"/>
            <expression value="extension.exists() != value.exists()"/>
            <source value="http://hl7.org/fhir/StructureDefinition/Extension"/>
          </constraint>
          <isModifier value="true"/>
          <isModifierReason
                            value="Modifier extensions are expected to modify the meaning or interpretation of the element that contains them"/>
          <isSummary value="true"/>
          <mapping>
            <identity value="rim"/>
            <map value="N/A"/>
          </mapping>
        </element>
        <element id="SubstanceDefinition.characterization.technique">
          <path value="SubstanceDefinition.characterization.technique"/>
          <short value="The method used to find the characterization e.g. HPLC"/>
          <definition
                      value="The method used to elucidate the characterization of the drug substance. Example: HPLC."/>
          <min value="0"/>
          <max value="1"/>
          <base>
            <path value="SubstanceDefinition.characterization.technique"/>
            <min value="0"/>
            <max value="1"/>
          </base>
          <type>
            <code value="CodeableConcept"/>
          </type>
          <constraint>
            <key value="ele-1"/>
            <severity value="error"/>
            <human value="All FHIR elements must have a @value or children"/>
            <expression
                        value="hasValue() or (children().count() &gt; id.count())"/>
            <source value="http://hl7.org/fhir/StructureDefinition/Element"/>
          </constraint>
          <mustSupport value="false"/>
          <isModifier value="false"/>
          <isSummary value="true"/>
          <binding>
            <extension
                       url="http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName">
              <valueString value="SubstanceStructureTechnique"/>
            </extension>
            <strength value="example"/>
            <description
                         value="The method used to elucidate the characterization of the drug substance."/>
            <valueSet
                      value="http://hl7.org/fhir/ValueSet/substance-structure-technique"/>
          </binding>
          <mapping>
            <identity value="idmp-substance"/>
            <map value="n/a"/>
          </mapping>
        </element>
        <element id="SubstanceDefinition.characterization.form">
          <path value="SubstanceDefinition.characterization.form"/>
          <short
                 value="Describes the nature of the chemical entity and explains, for instance, whether this is a base or a salt form"/>
          <definition
                      value="Describes the nature of the chemical entity and explains, for instance, whether this is a base or a salt form."/>
          <min value="0"/>
          <max value="1"/>
          <base>
            <path value="SubstanceDefinition.characterization.form"/>
            <min value="0"/>
            <max value="1"/>
          </base>
          <type>
            <code value="CodeableConcept"/>
          </type>
          <constraint>
            <key value="ele-1"/>
            <severity value="error"/>
            <human value="All FHIR elements must have a @value or children"/>
            <expression
                        value="hasValue() or (children().count() &gt; id.count())"/>
            <source value="http://hl7.org/fhir/StructureDefinition/Element"/>
          </constraint>
          <mustSupport value="false"/>
          <isModifier value="false"/>
          <isSummary value="true"/>
          <binding>
            <extension
                       url="http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName">
              <valueString value="SubstanceForm"/>
            </extension>
            <strength value="example"/>
            <valueSet value="http://hl7.org/fhir/ValueSet/substance-form"/>
          </binding>
          <mapping>
            <identity value="idmp-substance"/>
            <map value="n/a"/>
          </mapping>
        </element>
        <element id="SubstanceDefinition.characterization.description">
          <path value="SubstanceDefinition.characterization.description"/>
          <short
                 value="The description or justification in support of the interpretation of the data file"/>
          <definition
                      value="The description or justification in support of the interpretation of the data file."/>
          <min value="0"/>
          <max value="1"/>
          <base>
            <path value="SubstanceDefinition.characterization.description"/>
            <min value="0"/>
            <max value="1"/>
          </base>
          <type>
            <code value="markdown"/>
          </type>
          <constraint>
            <key value="ele-1"/>
            <severity value="error"/>
            <human value="All FHIR elements must have a @value or children"/>
            <expression
                        value="hasValue() or (children().count() &gt; id.count())"/>
            <source value="http://hl7.org/fhir/StructureDefinition/Element"/>
          </constraint>
          <mustSupport value="false"/>
          <isModifier value="false"/>
          <isSummary value="true"/>
          <mapping>
            <identity value="idmp-substance"/>
            <map value="n/a"/>
          </mapping>
        </element>
        <element id="SubstanceDefinition.characterization.file">
          <path value="SubstanceDefinition.characterization.file"/>
          <short
                 value="The data produced by the analytical instrument or a pictorial representation of that data. Examples: a JCAMP, JDX, or ADX file, or a chromatogram or spectrum analysis"/>
          <definition
                      value="The data produced by the analytical instrument or a pictorial representation of that data. Examples: a JCAMP, JDX, or ADX file, or a chromatogram or spectrum analysis."/>
          <min value="0"/>
          <max value="*"/>
          <base>
            <path value="SubstanceDefinition.characterization.file"/>
            <min value="0"/>
            <max value="*"/>
          </base>
          <type>
            <code value="Attachment"/>
          </type>
          <constraint>
            <key value="ele-1"/>
            <severity value="error"/>
            <human value="All FHIR elements must have a @value or children"/>
            <expression
                        value="hasValue() or (children().count() &gt; id.count())"/>
            <source value="http://hl7.org/fhir/StructureDefinition/Element"/>
          </constraint>
          <mustSupport value="false"/>
          <isModifier value="false"/>
          <isSummary value="true"/>
          <mapping>
            <identity value="idmp-substance"/>
            <map value="n/a"/>
          </mapping>
        </element>
        <element id="SubstanceDefinition.property">
          <path value="SubstanceDefinition.property"/>
          <short value="General specifications for this substance"/>
          <definition value="General specifications for this substance."/>
          <min value="0"/>
          <max value="*"/>
          <base>
            <path value="SubstanceDefinition.property"/>
            <min value="0"/>
            <max value="*"/>
          </base>
          <type>
            <code value="BackboneElement"/>
          </type>
          <constraint>
            <key value="ele-1"/>
            <severity value="error"/>
            <human value="All FHIR elements must have a @value or children"/>
            <expression
                        value="hasValue() or (children().count() &gt; id.count())"/>
            <source value="http://hl7.org/fhir/StructureDefinition/Element"/>
          </constraint>
          <mustSupport value="false"/>
          <isModifier value="false"/>
          <isSummary value="true"/>
          <mapping>
            <identity value="idmp-substance"/>
            <map value="Substance.Property"/>
          </mapping>
        </element>
        <element id="SubstanceDefinition.property.id">
          <path value="SubstanceDefinition.property.id"/>
          <representation value="xmlAttr"/>
          <short value="Unique id for inter-element referencing"/>
          <definition
                      value="Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces."/>
          <min value="0"/>
          <max value="1"/>
          <base>
            <path value="Element.id"/>
            <min value="0"/>
            <max value="1"/>
          </base>
          <type>
            <extension
                       url="http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type">
              <valueUrl value="string"/>
            </extension>
            <code value="http://hl7.org/fhirpath/System.String"/>
          </type>
          <condition value="ele-1"/>
          <isModifier value="false"/>
          <isSummary value="false"/>
          <mapping>
            <identity value="rim"/>
            <map value="n/a"/>
          </mapping>
        </element>
        <element id="SubstanceDefinition.property.extension">
          <path value="SubstanceDefinition.property.extension"/>
          <short value="Additional content defined by implementations"/>
          <definition
                      value="May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension."/>
          <comment
                   value="There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions.  The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone."/>
          <alias value="extensions"/>
          <alias value="user content"/>
          <min value="0"/>
          <max value="*"/>
          <base>
            <path value="Element.extension"/>
            <min value="0"/>
            <max value="*"/>
          </base>
          <type>
            <code value="Extension"/>
          </type>
          <constraint>
            <key value="ele-1"/>
            <severity value="error"/>
            <human value="All FHIR elements must have a @value or children"/>
            <expression
                        value="hasValue() or (children().count() &gt; id.count())"/>
            <source value="http://hl7.org/fhir/StructureDefinition/Element"/>
          </constraint>
          <constraint>
            <key value="ext-1"/>
            <severity value="error"/>
            <human value="Must have either extensions or value[x], not both"/>
            <expression value="extension.exists() != value.exists()"/>
            <source value="http://hl7.org/fhir/StructureDefinition/Extension"/>
          </constraint>
          <isModifier value="false"/>
          <isSummary value="false"/>
          <mapping>
            <identity value="rim"/>
            <map value="n/a"/>
          </mapping>
        </element>
        <element id="SubstanceDefinition.property.modifierExtension">
          <path value="SubstanceDefinition.property.modifierExtension"/>
          <short value="Extensions that cannot be ignored even if unrecognized"/>
          <definition
                      value="May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.

    Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself)."/>
          <comment
                   value="There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions.  The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone."/>
          <requirements
                        value="Modifier extensions allow for extensions that *cannot* be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored.  This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the [definition of modifier extensions](http://hl7.org/fhir/R5/extensibility.html#modifierExtension)."/>
          <alias value="extensions"/>
          <alias value="user content"/>
          <alias value="modifiers"/>
          <min value="0"/>
          <max value="*"/>
          <base>
            <path value="BackboneElement.modifierExtension"/>
            <min value="0"/>
            <max value="*"/>
          </base>
          <type>
            <code value="Extension"/>
          </type>
          <constraint>
            <key value="ele-1"/>
            <severity value="error"/>
            <human value="All FHIR elements must have a @value or children"/>
            <expression
                        value="hasValue() or (children().count() &gt; id.count())"/>
            <source value="http://hl7.org/fhir/StructureDefinition/Element"/>
          </constraint>
          <constraint>
            <key value="ext-1"/>
            <severity value="error"/>
            <human value="Must have either extensions or value[x], not both"/>
            <expression value="extension.exists() != value.exists()"/>
            <source value="http://hl7.org/fhir/StructureDefinition/Extension"/>
          </constraint>
          <isModifier value="true"/>
          <isModifierReason
                            value="Modifier extensions are expected to modify the meaning or interpretation of the element that contains them"/>
          <isSummary value="true"/>
          <mapping>
            <identity value="rim"/>
            <map value="N/A"/>
          </mapping>
        </element>
        <element id="SubstanceDefinition.property.type">
          <path value="SubstanceDefinition.property.type"/>
          <short value="A code expressing the type of property"/>
          <definition value="A code expressing the type of property."/>
          <min value="1"/>
          <max value="1"/>
          <base>
            <path value="SubstanceDefinition.property.type"/>
            <min value="1"/>
            <max value="1"/>
          </base>
          <type>
            <code value="CodeableConcept"/>
          </type>
          <constraint>
            <key value="ele-1"/>
            <severity value="error"/>
            <human value="All FHIR elements must have a @value or children"/>
            <expression
                        value="hasValue() or (children().count() &gt; id.count())"/>
            <source value="http://hl7.org/fhir/StructureDefinition/Element"/>
          </constraint>
          <mustSupport value="false"/>
          <isModifier value="false"/>
          <isSummary value="true"/>
          <binding>
            <extension
                       url="http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName">
              <valueString value="SNOMEDCTCharacteristicCodes"/>
            </extension>
            <strength value="example"/>
            <description
                         value="This value set includes all observable entity codes from SNOMED CT - provided as an exemplar value set."/>
            <valueSet
                      value="http://hl7.org/fhir/ValueSet/product-characteristic-codes"/>
          </binding>
          <mapping>
            <identity value="idmp-substance"/>
            <map value="Property.Property_Type"/>
          </mapping>
        </element>
        <element id="SubstanceDefinition.property.value[x]">
          <path value="SubstanceDefinition.property.value[x]"/>
          <short value="A value for the property"/>
          <definition value="A value for the property."/>
          <min value="0"/>
          <max value="1"/>
          <base>
            <path value="SubstanceDefinition.property.value[x]"/>
            <min value="0"/>
            <max value="1"/>
          </base>
          <type>
            <code value="CodeableConcept"/>
          </type>
          <type>
            <code value="Quantity"/>
          </type>
          <type>
            <code value="date"/>
          </type>
          <type>
            <code value="boolean"/>
          </type>
          <type>
            <code value="Attachment"/>
          </type>
          <constraint>
            <key value="ele-1"/>
            <severity value="error"/>
            <human value="All FHIR elements must have a @value or children"/>
            <expression
                        value="hasValue() or (children().count() &gt; id.count())"/>
            <source value="http://hl7.org/fhir/StructureDefinition/Element"/>
          </constraint>
          <mustSupport value="false"/>
          <isModifier value="false"/>
          <isSummary value="true"/>
          <mapping>
            <identity value="idmp-substance"/>
            <map value="Physical Characteristics, attribute's value"/>
          </mapping>
        </element>
        <element id="SubstanceDefinition.referenceInformation">
          <path value="SubstanceDefinition.referenceInformation"/>
          <short value="General information detailing this substance"/>
          <definition value="General information detailing this substance."/>
          <min value="0"/>
          <max value="1"/>
          <base>
            <path value="SubstanceDefinition.referenceInformation"/>
            <min value="0"/>
            <max value="1"/>
          </base>
          <type>
            <code value="Reference"/>
            <targetProfile
                           value="http://hl7.org/fhir/StructureDefinition/SubstanceReferenceInformation"/>
          </type>
          <constraint>
            <key value="ele-1"/>
            <severity value="error"/>
            <human value="All FHIR elements must have a @value or children"/>
            <expression
                        value="hasValue() or (children().count() &gt; id.count())"/>
            <source value="http://hl7.org/fhir/StructureDefinition/Element"/>
          </constraint>
          <mustSupport value="false"/>
          <isModifier value="false"/>
          <isSummary value="true"/>
          <mapping>
            <identity value="idmp-substance"/>
            <map value="Reference_Information"/>
          </mapping>
        </element>
        <element id="SubstanceDefinition.molecularWeight">
          <path value="SubstanceDefinition.molecularWeight"/>
          <short value="The average mass of a molecule of a compound"/>
          <definition
                      value="The average mass of a molecule of a compound compared to 1/12 the mass of carbon 12 and calculated as the sum of the atomic weights of the constituent atoms."/>
          <min value="0"/>
          <max value="*"/>
          <base>
            <path value="SubstanceDefinition.molecularWeight"/>
            <min value="0"/>
            <max value="*"/>
          </base>
          <type>
            <code value="BackboneElement"/>
          </type>
          <constraint>
            <key value="ele-1"/>
            <severity value="error"/>
            <human value="All FHIR elements must have a @value or children"/>
            <expression
                        value="hasValue() or (children().count() &gt; id.count())"/>
            <source value="http://hl7.org/fhir/StructureDefinition/Element"/>
          </constraint>
          <mustSupport value="false"/>
          <isModifier value="false"/>
          <isSummary value="true"/>
        </element>
        <element id="SubstanceDefinition.molecularWeight.id">
          <path value="SubstanceDefinition.molecularWeight.id"/>
          <representation value="xmlAttr"/>
          <short value="Unique id for inter-element referencing"/>
          <definition
                      value="Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces."/>
          <min value="0"/>
          <max value="1"/>
          <base>
            <path value="Element.id"/>
            <min value="0"/>
            <max value="1"/>
          </base>
          <type>
            <extension
                       url="http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type">
              <valueUrl value="string"/>
            </extension>
            <code value="http://hl7.org/fhirpath/System.String"/>
          </type>
          <condition value="ele-1"/>
          <isModifier value="false"/>
          <isSummary value="false"/>
          <mapping>
            <identity value="rim"/>
            <map value="n/a"/>
          </mapping>
        </element>
        <element id="SubstanceDefinition.molecularWeight.extension">
          <path value="SubstanceDefinition.molecularWeight.extension"/>
          <short value="Additional content defined by implementations"/>
          <definition
                      value="May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension."/>
          <comment
                   value="There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions.  The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone."/>
          <alias value="extensions"/>
          <alias value="user content"/>
          <min value="0"/>
          <max value="*"/>
          <base>
            <path value="Element.extension"/>
            <min value="0"/>
            <max value="*"/>
          </base>
          <type>
            <code value="Extension"/>
          </type>
          <constraint>
            <key value="ele-1"/>
            <severity value="error"/>
            <human value="All FHIR elements must have a @value or children"/>
            <expression
                        value="hasValue() or (children().count() &gt; id.count())"/>
            <source value="http://hl7.org/fhir/StructureDefinition/Element"/>
          </constraint>
          <constraint>
            <key value="ext-1"/>
            <severity value="error"/>
            <human value="Must have either extensions or value[x], not both"/>
            <expression value="extension.exists() != value.exists()"/>
            <source value="http://hl7.org/fhir/StructureDefinition/Extension"/>
          </constraint>
          <isModifier value="false"/>
          <isSummary value="false"/>
          <mapping>
            <identity value="rim"/>
            <map value="n/a"/>
          </mapping>
        </element>
        <element id="SubstanceDefinition.molecularWeight.modifierExtension">
          <path value="SubstanceDefinition.molecularWeight.modifierExtension"/>
          <short value="Extensions that cannot be ignored even if unrecognized"/>
          <definition
                      value="May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.

    Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself)."/>
          <comment
                   value="There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions.  The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone."/>
          <requirements
                        value="Modifier extensions allow for extensions that *cannot* be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored.  This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the [definition of modifier extensions](http://hl7.org/fhir/R5/extensibility.html#modifierExtension)."/>
          <alias value="extensions"/>
          <alias value="user content"/>
          <alias value="modifiers"/>
          <min value="0"/>
          <max value="*"/>
          <base>
            <path value="BackboneElement.modifierExtension"/>
            <min value="0"/>
            <max value="*"/>
          </base>
          <type>
            <code value="Extension"/>
          </type>
          <constraint>
            <key value="ele-1"/>
            <severity value="error"/>
            <human value="All FHIR elements must have a @value or children"/>
            <expression
                        value="hasValue() or (children().count() &gt; id.count())"/>
            <source value="http://hl7.org/fhir/StructureDefinition/Element"/>
          </constraint>
          <constraint>
            <key value="ext-1"/>
            <severity value="error"/>
            <human value="Must have either extensions or value[x], not both"/>
            <expression value="extension.exists() != value.exists()"/>
            <source value="http://hl7.org/fhir/StructureDefinition/Extension"/>
          </constraint>
          <isModifier value="true"/>
          <isModifierReason
                            value="Modifier extensions are expected to modify the meaning or interpretation of the element that contains them"/>
          <isSummary value="true"/>
          <mapping>
            <identity value="rim"/>
            <map value="N/A"/>
          </mapping>
        </element>
        <element id="SubstanceDefinition.molecularWeight.method">
          <path value="SubstanceDefinition.molecularWeight.method"/>
          <short value="The method by which the weight was determined"/>
          <definition
                      value="The method by which the molecular weight was determined."/>
          <min value="0"/>
          <max value="1"/>
          <base>
            <path value="SubstanceDefinition.molecularWeight.method"/>
            <min value="0"/>
            <max value="1"/>
          </base>
          <type>
            <code value="CodeableConcept"/>
          </type>
          <constraint>
            <key value="ele-1"/>
            <severity value="error"/>
            <human value="All FHIR elements must have a @value or children"/>
            <expression
                        value="hasValue() or (children().count() &gt; id.count())"/>
            <source value="http://hl7.org/fhir/StructureDefinition/Element"/>
          </constraint>
          <mustSupport value="false"/>
          <isModifier value="false"/>
          <isSummary value="true"/>
          <binding>
            <extension
                       url="http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName">
              <valueString value="SubstanceWeightMethod"/>
            </extension>
            <strength value="example"/>
            <description
                         value="The method by which the substance weight was measured."/>
            <valueSet
                      value="http://hl7.org/fhir/ValueSet/substance-weight-method"/>
          </binding>
          <mapping>
            <identity value="idmp-substance"/>
            <map value="Molecular_Weight.Molecular_Weight_Method"/>
          </mapping>
        </element>
        <element id="SubstanceDefinition.molecularWeight.type">
          <path value="SubstanceDefinition.molecularWeight.type"/>
          <short
                 value="Type of molecular weight e.g. exact, average, weight average"/>
          <definition
                      value="Type of molecular weight such as exact, average (also known as. number average), weight average."/>
          <min value="0"/>
          <max value="1"/>
          <base>
            <path value="SubstanceDefinition.molecularWeight.type"/>
            <min value="0"/>
            <max value="1"/>
          </base>
          <type>
            <code value="CodeableConcept"/>
          </type>
          <constraint>
            <key value="ele-1"/>
            <severity value="error"/>
            <human value="All FHIR elements must have a @value or children"/>
            <expression
                        value="hasValue() or (children().count() &gt; id.count())"/>
            <source value="http://hl7.org/fhir/StructureDefinition/Element"/>
          </constraint>
          <mustSupport value="false"/>
          <isModifier value="false"/>
          <isSummary value="true"/>
          <binding>
            <extension
                       url="http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName">
              <valueString value="SubstanceWeightType"/>
            </extension>
            <strength value="example"/>
            <description value="The type of substance weight measurement."/>
            <valueSet value="http://hl7.org/fhir/ValueSet/substance-weight-type"/>
          </binding>
          <mapping>
            <identity value="idmp-substance"/>
            <map value="Molecular_Weight.Molecular_Weight_Type"/>
          </mapping>
        </element>
        <element id="SubstanceDefinition.molecularWeight.amount">
          <path value="SubstanceDefinition.molecularWeight.amount"/>
          <short
                 value="Used to capture quantitative values for a variety of elements"/>
          <definition
                      value="Used to capture quantitative values for a variety of elements. If only limits are given, the arithmetic mean would be the average. If only a single definite value for a given element is given, it would be captured in this field."/>
          <min value="1"/>
          <max value="1"/>
          <base>
            <path value="SubstanceDefinition.molecularWeight.amount"/>
            <min value="1"/>
            <max value="1"/>
          </base>
          <type>
            <code value="Quantity"/>
          </type>
          <constraint>
            <key value="ele-1"/>
            <severity value="error"/>
            <human value="All FHIR elements must have a @value or children"/>
            <expression
                        value="hasValue() or (children().count() &gt; id.count())"/>
            <source value="http://hl7.org/fhir/StructureDefinition/Element"/>
          </constraint>
          <mustSupport value="false"/>
          <isModifier value="false"/>
          <isSummary value="true"/>
          <mapping>
            <identity value="idmp-substance"/>
            <map value="Molecular_Weight.Amount"/>
          </mapping>
        </element>
        <element id="SubstanceDefinition.structure">
          <path value="SubstanceDefinition.structure"/>
          <short value="Structural information"/>
          <definition value="Structural information."/>
          <min value="0"/>
          <max value="1"/>
          <base>
            <path value="SubstanceDefinition.structure"/>
            <min value="0"/>
            <max value="1"/>
          </base>
          <type>
            <code value="BackboneElement"/>
          </type>
          <constraint>
            <key value="ele-1"/>
            <severity value="error"/>
            <human value="All FHIR elements must have a @value or children"/>
            <expression
                        value="hasValue() or (children().count() &gt; id.count())"/>
            <source value="http://hl7.org/fhir/StructureDefinition/Element"/>
          </constraint>
          <constraint>
            <key value="cmc-structure-representation-required"/>
            <severity value="error"/>
            <human
                   value="Either a file or string structure representation is required"/>
            <expression
                        value="representation.type.coding.where(
      system = 'http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl'
      and (code in 'C45253' | 'C103240')
    ).exists()"/>
            <source
                    value="http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pqcmc-component-substance"/>
          </constraint>
          <mustSupport value="false"/>
          <isModifier value="false"/>
          <isSummary value="true"/>
          <mapping>
            <identity value="idmp-substance"/>
            <map value="Substance.Structure"/>
          </mapping>
        </element>
        <element id="SubstanceDefinition.structure.id">
          <path value="SubstanceDefinition.structure.id"/>
          <representation value="xmlAttr"/>
          <short value="Unique id for inter-element referencing"/>
          <definition
                      value="Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces."/>
          <min value="0"/>
          <max value="1"/>
          <base>
            <path value="Element.id"/>
            <min value="0"/>
            <max value="1"/>
          </base>
          <type>
            <extension
                       url="http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type">
              <valueUrl value="string"/>
            </extension>
            <code value="http://hl7.org/fhirpath/System.String"/>
          </type>
          <condition value="ele-1"/>
          <isModifier value="false"/>
          <isSummary value="false"/>
          <mapping>
            <identity value="rim"/>
            <map value="n/a"/>
          </mapping>
        </element>
        <element id="SubstanceDefinition.structure.extension">
          <path value="SubstanceDefinition.structure.extension"/>
          <short value="Additional content defined by implementations"/>
          <definition
                      value="May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension."/>
          <comment
                   value="There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions.  The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone."/>
          <alias value="extensions"/>
          <alias value="user content"/>
          <min value="0"/>
          <max value="*"/>
          <base>
            <path value="Element.extension"/>
            <min value="0"/>
            <max value="*"/>
          </base>
          <type>
            <code value="Extension"/>
          </type>
          <constraint>
            <key value="ele-1"/>
            <severity value="error"/>
            <human value="All FHIR elements must have a @value or children"/>
            <expression
                        value="hasValue() or (children().count() &gt; id.count())"/>
            <source value="http://hl7.org/fhir/StructureDefinition/Element"/>
          </constraint>
          <constraint>
            <key value="ext-1"/>
            <severity value="error"/>
            <human value="Must have either extensions or value[x], not both"/>
            <expression value="extension.exists() != value.exists()"/>
            <source value="http://hl7.org/fhir/StructureDefinition/Extension"/>
          </constraint>
          <isModifier value="false"/>
          <isSummary value="false"/>
          <mapping>
            <identity value="rim"/>
            <map value="n/a"/>
          </mapping>
        </element>
        <element id="SubstanceDefinition.structure.modifierExtension">
          <path value="SubstanceDefinition.structure.modifierExtension"/>
          <short value="Extensions that cannot be ignored even if unrecognized"/>
          <definition
                      value="May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.

    Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself)."/>
          <comment
                   value="There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions.  The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone."/>
          <requirements
                        value="Modifier extensions allow for extensions that *cannot* be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored.  This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the [definition of modifier extensions](http://hl7.org/fhir/R5/extensibility.html#modifierExtension)."/>
          <alias value="extensions"/>
          <alias value="user content"/>
          <alias value="modifiers"/>
          <min value="0"/>
          <max value="*"/>
          <base>
            <path value="BackboneElement.modifierExtension"/>
            <min value="0"/>
            <max value="*"/>
          </base>
          <type>
            <code value="Extension"/>
          </type>
          <constraint>
            <key value="ele-1"/>
            <severity value="error"/>
            <human value="All FHIR elements must have a @value or children"/>
            <expression
                        value="hasValue() or (children().count() &gt; id.count())"/>
            <source value="http://hl7.org/fhir/StructureDefinition/Element"/>
          </constraint>
          <constraint>
            <key value="ext-1"/>
            <severity value="error"/>
            <human value="Must have either extensions or value[x], not both"/>
            <expression value="extension.exists() != value.exists()"/>
            <source value="http://hl7.org/fhir/StructureDefinition/Extension"/>
          </constraint>
          <isModifier value="true"/>
          <isModifierReason
                            value="Modifier extensions are expected to modify the meaning or interpretation of the element that contains them"/>
          <isSummary value="true"/>
          <mapping>
            <identity value="rim"/>
            <map value="N/A"/>
          </mapping>
        </element>
        <element id="SubstanceDefinition.structure.stereochemistry">
          <path value="SubstanceDefinition.structure.stereochemistry"/>
          <short value="Stereochemistry type"/>
          <definition value="Stereochemistry type."/>
          <min value="0"/>
          <max value="1"/>
          <base>
            <path value="SubstanceDefinition.structure.stereochemistry"/>
            <min value="0"/>
            <max value="1"/>
          </base>
          <type>
            <code value="CodeableConcept"/>
          </type>
          <constraint>
            <key value="ele-1"/>
            <severity value="error"/>
            <human value="All FHIR elements must have a @value or children"/>
            <expression
                        value="hasValue() or (children().count() &gt; id.count())"/>
            <source value="http://hl7.org/fhir/StructureDefinition/Element"/>
          </constraint>
          <mustSupport value="false"/>
          <isModifier value="false"/>
          <isSummary value="true"/>
          <binding>
            <extension
                       url="http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName">
              <valueString value="SubstanceStereochemistry"/>
            </extension>
            <strength value="example"/>
            <description value="The optical rotation type of a substance."/>
            <valueSet
                      value="http://hl7.org/fhir/ValueSet/substance-stereochemistry"/>
          </binding>
          <mapping>
            <identity value="idmp-substance"/>
            <map value="Structure.Stereochemistry"/>
          </mapping>
        </element>
        <element id="SubstanceDefinition.structure.opticalActivity">
          <path value="SubstanceDefinition.structure.opticalActivity"/>
          <short value="Optical activity type"/>
          <definition value="Optical activity type."/>
          <min value="0"/>
          <max value="1"/>
          <base>
            <path value="SubstanceDefinition.structure.opticalActivity"/>
            <min value="0"/>
            <max value="1"/>
          </base>
          <type>
            <code value="CodeableConcept"/>
          </type>
          <constraint>
            <key value="ele-1"/>
            <severity value="error"/>
            <human value="All FHIR elements must have a @value or children"/>
            <expression
                        value="hasValue() or (children().count() &gt; id.count())"/>
            <source value="http://hl7.org/fhir/StructureDefinition/Element"/>
          </constraint>
          <mustSupport value="false"/>
          <isModifier value="false"/>
          <isSummary value="true"/>
          <binding>
            <extension
                       url="http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName">
              <valueString value="SubstanceOpticalActivity"/>
            </extension>
            <strength value="example"/>
            <description value="The optical rotation type of a substance."/>
            <valueSet
                      value="http://hl7.org/fhir/ValueSet/substance-optical-activity"/>
          </binding>
          <mapping>
            <identity value="idmp-substance"/>
            <map value="Structure.Optical_Activity"/>
          </mapping>
        </element>
        <element id="SubstanceDefinition.structure.molecularFormula">
          <path value="SubstanceDefinition.structure.molecularFormula"/>
          <short
                 value="An expression which states the number and type of atoms present in a molecule of a substance"/>
          <definition
                      value="An expression which states the number and type of atoms present in a molecule of a substance."/>
          <min value="0"/>
          <max value="1"/>
          <base>
            <path value="SubstanceDefinition.structure.molecularFormula"/>
            <min value="0"/>
            <max value="1"/>
          </base>
          <type>
            <code value="string"/>
          </type>
          <constraint>
            <key value="ele-1"/>
            <severity value="error"/>
            <human value="All FHIR elements must have a @value or children"/>
            <expression
                        value="hasValue() or (children().count() &gt; id.count())"/>
            <source value="http://hl7.org/fhir/StructureDefinition/Element"/>
          </constraint>
          <mustSupport value="false"/>
          <isModifier value="false"/>
          <isSummary value="true"/>
          <mapping>
            <identity value="idmp-substance"/>
            <map value="Structure.Molecular_Formula"/>
          </mapping>
        </element>
        <element id="SubstanceDefinition.structure.molecularFormulaByMoiety">
          <path value="SubstanceDefinition.structure.molecularFormulaByMoiety"/>
          <short value="Specified per moiety according to the Hill system"/>
          <definition
                      value="Specified per moiety according to the Hill system, i.e. first C, then H, then alphabetical, each moiety separated by a dot."/>
          <min value="0"/>
          <max value="1"/>
          <base>
            <path value="SubstanceDefinition.structure.molecularFormulaByMoiety"/>
            <min value="0"/>
            <max value="1"/>
          </base>
          <type>
            <code value="string"/>
          </type>
          <constraint>
            <key value="ele-1"/>
            <severity value="error"/>
            <human value="All FHIR elements must have a @value or children"/>
            <expression
                        value="hasValue() or (children().count() &gt; id.count())"/>
            <source value="http://hl7.org/fhir/StructureDefinition/Element"/>
          </constraint>
          <mustSupport value="false"/>
          <isModifier value="false"/>
          <isSummary value="true"/>
          <mapping>
            <identity value="idmp-substance"/>
            <map value="Structure.Molecular_Formula_By_Moiety"/>
          </mapping>
        </element>
        <element id="SubstanceDefinition.structure.molecularWeight">
          <path value="SubstanceDefinition.structure.molecularWeight"/>
          <short value="The molecular weight or weight range"/>
          <definition
                      value="The molecular weight or weight range (for proteins, polymers or nucleic acids)."/>
          <min value="0"/>
          <max value="1"/>
          <base>
            <path value="SubstanceDefinition.structure.molecularWeight"/>
            <min value="0"/>
            <max value="1"/>
          </base>
          <contentReference
                            value="http://hl7.org/fhir/StructureDefinition/SubstanceDefinition#SubstanceDefinition.molecularWeight"/>
          <constraint>
            <key value="ele-1"/>
            <severity value="error"/>
            <human value="All FHIR elements must have a @value or children"/>
            <expression
                        value="hasValue() or (children().count() &gt; id.count())"/>
            <source value="http://hl7.org/fhir/StructureDefinition/Element"/>
          </constraint>
          <mustSupport value="false"/>
          <isModifier value="false"/>
          <isSummary value="true"/>
          <mapping>
            <identity value="idmp-substance"/>
            <map value="Structure.Molecular_Weight"/>
          </mapping>
        </element>
        <element id="SubstanceDefinition.structure.technique">
          <path value="SubstanceDefinition.structure.technique"/>
          <short value="The method used to find the structure e.g. X-ray, NMR"/>
          <definition
                      value="The method used to elucidate the structure of the drug substance. Examples: X-ray, NMR, Peptide mapping, Ligand binding assay."/>
          <min value="0"/>
          <max value="*"/>
          <base>
            <path value="SubstanceDefinition.structure.technique"/>
            <min value="0"/>
            <max value="*"/>
          </base>
          <type>
            <code value="CodeableConcept"/>
          </type>
          <constraint>
            <key value="ele-1"/>
            <severity value="error"/>
            <human value="All FHIR elements must have a @value or children"/>
            <expression
                        value="hasValue() or (children().count() &gt; id.count())"/>
            <source value="http://hl7.org/fhir/StructureDefinition/Element"/>
          </constraint>
          <mustSupport value="false"/>
          <isModifier value="false"/>
          <isSummary value="true"/>
          <binding>
            <extension
                       url="http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName">
              <valueString value="SubstanceStructureTechnique"/>
            </extension>
            <strength value="example"/>
            <description
                         value="The method used to elucidate the structure of the drug substance."/>
            <valueSet
                      value="http://hl7.org/fhir/ValueSet/substance-structure-technique"/>
          </binding>
          <mapping>
            <identity value="idmp-substance"/>
            <map value="n/a"/>
          </mapping>
        </element>
        <element id="SubstanceDefinition.structure.sourceDocument">
          <path value="SubstanceDefinition.structure.sourceDocument"/>
          <short value="Source of information for the structure"/>
          <definition value="The source of information about the structure."/>
          <min value="0"/>
          <max value="*"/>
          <base>
            <path value="SubstanceDefinition.structure.sourceDocument"/>
            <min value="0"/>
            <max value="*"/>
          </base>
          <type>
            <code value="Reference"/>
            <targetProfile
                           value="http://hl7.org/fhir/StructureDefinition/DocumentReference"/>
          </type>
          <constraint>
            <key value="ele-1"/>
            <severity value="error"/>
            <human value="All FHIR elements must have a @value or children"/>
            <expression
                        value="hasValue() or (children().count() &gt; id.count())"/>
            <source value="http://hl7.org/fhir/StructureDefinition/Element"/>
          </constraint>
          <mustSupport value="false"/>
          <isModifier value="false"/>
          <isSummary value="true"/>
          <mapping>
            <identity value="idmp-substance"/>
            <map value="Structure.Reference_Source"/>
          </mapping>
        </element>
        <element id="SubstanceDefinition.structure.representation">
          <path value="SubstanceDefinition.structure.representation"/>
          <slicing>
            <discriminator>
              <type value="value"/>
              <path value="type"/>
            </discriminator>
            <ordered value="false"/>
            <rules value="closed"/>
          </slicing>
          <short
                 value="Impurity Structure Graphic | Impurity Structure Data File"/>
          <definition value="A depiction of the structure of the substance."/>
          <min value="0"/>
          <max value="*"/>
          <base>
            <path value="SubstanceDefinition.structure.representation"/>
            <min value="0"/>
            <max value="*"/>
          </base>
          <type>
            <code value="BackboneElement"/>
          </type>
          <constraint>
            <key value="ele-1"/>
            <severity value="error"/>
            <human value="All FHIR elements must have a @value or children"/>
            <expression
                        value="hasValue() or (children().count() &gt; id.count())"/>
            <source value="http://hl7.org/fhir/StructureDefinition/Element"/>
          </constraint>
          <mustSupport value="true"/>
          <isModifier value="false"/>
          <isSummary value="true"/>
          <mapping>
            <identity value="idmp-substance"/>
            <map value="Structure.Structural_Representation"/>
          </mapping>
        </element>
        <element id="SubstanceDefinition.structure.representation.id">
          <path value="SubstanceDefinition.structure.representation.id"/>
          <representation value="xmlAttr"/>
          <short value="Unique id for inter-element referencing"/>
          <definition
                      value="Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces."/>
          <min value="0"/>
          <max value="1"/>
          <base>
            <path value="Element.id"/>
            <min value="0"/>
            <max value="1"/>
          </base>
          <type>
            <extension
                       url="http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type">
              <valueUrl value="string"/>
            </extension>
            <code value="http://hl7.org/fhirpath/System.String"/>
          </type>
          <condition value="ele-1"/>
          <isModifier value="false"/>
          <isSummary value="false"/>
          <mapping>
            <identity value="rim"/>
            <map value="n/a"/>
          </mapping>
        </element>
        <element id="SubstanceDefinition.structure.representation.extension">
          <path value="SubstanceDefinition.structure.representation.extension"/>
          <short value="Additional content defined by implementations"/>
          <definition
                      value="May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension."/>
          <comment
                   value="There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions.  The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone."/>
          <alias value="extensions"/>
          <alias value="user content"/>
          <min value="0"/>
          <max value="*"/>
          <base>
            <path value="Element.extension"/>
            <min value="0"/>
            <max value="*"/>
          </base>
          <type>
            <code value="Extension"/>
          </type>
          <constraint>
            <key value="ele-1"/>
            <severity value="error"/>
            <human value="All FHIR elements must have a @value or children"/>
            <expression
                        value="hasValue() or (children().count() &gt; id.count())"/>
            <source value="http://hl7.org/fhir/StructureDefinition/Element"/>
          </constraint>
          <constraint>
            <key value="ext-1"/>
            <severity value="error"/>
            <human value="Must have either extensions or value[x], not both"/>
            <expression value="extension.exists() != value.exists()"/>
            <source value="http://hl7.org/fhir/StructureDefinition/Extension"/>
          </constraint>
          <isModifier value="false"/>
          <isSummary value="false"/>
          <mapping>
            <identity value="rim"/>
            <map value="n/a"/>
          </mapping>
        </element>
        <element
                 id="SubstanceDefinition.structure.representation.modifierExtension">
          <path
                value="SubstanceDefinition.structure.representation.modifierExtension"/>
          <short value="Extensions that cannot be ignored even if unrecognized"/>
          <definition
                      value="May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.

    Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself)."/>
          <comment
                   value="There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions.  The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone."/>
          <requirements
                        value="Modifier extensions allow for extensions that *cannot* be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored.  This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the [definition of modifier extensions](http://hl7.org/fhir/R5/extensibility.html#modifierExtension)."/>
          <alias value="extensions"/>
          <alias value="user content"/>
          <alias value="modifiers"/>
          <min value="0"/>
          <max value="*"/>
          <base>
            <path value="BackboneElement.modifierExtension"/>
            <min value="0"/>
            <max value="*"/>
          </base>
          <type>
            <code value="Extension"/>
          </type>
          <constraint>
            <key value="ele-1"/>
            <severity value="error"/>
            <human value="All FHIR elements must have a @value or children"/>
            <expression
                        value="hasValue() or (children().count() &gt; id.count())"/>
            <source value="http://hl7.org/fhir/StructureDefinition/Element"/>
          </constraint>
          <constraint>
            <key value="ext-1"/>
            <severity value="error"/>
            <human value="Must have either extensions or value[x], not both"/>
            <expression value="extension.exists() != value.exists()"/>
            <source value="http://hl7.org/fhir/StructureDefinition/Extension"/>
          </constraint>
          <isModifier value="true"/>
          <isModifierReason
                            value="Modifier extensions are expected to modify the meaning or interpretation of the element that contains them"/>
          <isSummary value="true"/>
          <mapping>
            <identity value="rim"/>
            <map value="N/A"/>
          </mapping>
        </element>
        <element id="SubstanceDefinition.structure.representation.type">
          <path value="SubstanceDefinition.structure.representation.type"/>
          <short
                 value="The kind of structural representation (e.g. full, partial)"/>
          <definition
                      value="The kind of structural representation (e.g. full, partial)."/>
          <min value="1"/>
          <max value="1"/>
          <base>
            <path value="SubstanceDefinition.structure.representation.type"/>
            <min value="0"/>
            <max value="1"/>
          </base>
          <type>
            <code value="CodeableConcept"/>
          </type>
          <constraint>
            <key value="ele-1"/>
            <severity value="error"/>
            <human value="All FHIR elements must have a @value or children"/>
            <expression
                        value="hasValue() or (children().count() &gt; id.count())"/>
            <source value="http://hl7.org/fhir/StructureDefinition/Element"/>
          </constraint>
          <mustSupport value="true"/>
          <isModifier value="false"/>
          <isSummary value="true"/>
          <binding>
            <strength value="required"/>
            <valueSet
                      value="http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-representation-types"/>
          </binding>
          <mapping>
            <identity value="idmp-substance"/>
            <map
                 value="Structural_Representation.Structural_Representation_Type"/>
          </mapping>
        </element>
        <element
                 id="SubstanceDefinition.structure.representation.representation">
          <path
                value="SubstanceDefinition.structure.representation.representation"/>
          <short
                 value="The structural representation as a text string in a standard format"/>
          <definition
                      value="The structural representation as a text string in a standard format."/>
          <min value="0"/>
          <max value="1"/>
          <base>
            <path
                  value="SubstanceDefinition.structure.representation.representation"/>
            <min value="0"/>
            <max value="1"/>
          </base>
          <type>
            <code value="string"/>
          </type>
          <constraint>
            <key value="ele-1"/>
            <severity value="error"/>
            <human value="All FHIR elements must have a @value or children"/>
            <expression
                        value="hasValue() or (children().count() &gt; id.count())"/>
            <source value="http://hl7.org/fhir/StructureDefinition/Element"/>
          </constraint>
          <mustSupport value="false"/>
          <isModifier value="false"/>
          <isSummary value="true"/>
          <mapping>
            <identity value="idmp-substance"/>
            <map value="Structural_Representation.Structural_Representation"/>
          </mapping>
        </element>
        <element id="SubstanceDefinition.structure.representation.format">
          <path value="SubstanceDefinition.structure.representation.format"/>
          <short
                 value="The format of the representation e.g. InChI, SMILES, MOLFILE (note: not the physical file format)"/>
          <definition
                      value="The format of the representation e.g. InChI, SMILES, MOLFILE, CDX, SDF, PDB, mmCIF. The logical content type rather than the physical file format of a document."/>
          <min value="0"/>
          <max value="1"/>
          <base>
            <path value="SubstanceDefinition.structure.representation.format"/>
            <min value="0"/>
            <max value="1"/>
          </base>
          <type>
            <code value="CodeableConcept"/>
          </type>
          <constraint>
            <key value="ele-1"/>
            <severity value="error"/>
            <human value="All FHIR elements must have a @value or children"/>
            <expression
                        value="hasValue() or (children().count() &gt; id.count())"/>
            <source value="http://hl7.org/fhir/StructureDefinition/Element"/>
          </constraint>
          <mustSupport value="false"/>
          <isModifier value="false"/>
          <isSummary value="true"/>
          <binding>
            <extension
                       url="http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName">
              <valueString value="SubstanceRepresentationFormat"/>
            </extension>
            <strength value="example"/>
            <description value="A format of a substance representation."/>
            <valueSet
                      value="http://hl7.org/fhir/ValueSet/substance-representation-format"/>
          </binding>
          <mapping>
            <identity value="idmp-substance"/>
            <map value="n/a"/>
          </mapping>
        </element>
        <element id="SubstanceDefinition.structure.representation.document">
          <path value="SubstanceDefinition.structure.representation.document"/>
          <short
                 value="An attachment with the structural representation e.g. a structure graphic or AnIML file"/>
          <definition
                      value="An attached file with the structural representation e.g. a molecular structure graphic of the substance, a JCAMP or AnIML file."/>
          <min value="0"/>
          <max value="1"/>
          <base>
            <path value="SubstanceDefinition.structure.representation.document"/>
            <min value="0"/>
            <max value="1"/>
          </base>
          <type>
            <code value="Reference"/>
            <targetProfile
                           value="http://hl7.org/fhir/StructureDefinition/DocumentReference"/>
          </type>
          <constraint>
            <key value="ele-1"/>
            <severity value="error"/>
            <human value="All FHIR elements must have a @value or children"/>
            <expression
                        value="hasValue() or (children().count() &gt; id.count())"/>
            <source value="http://hl7.org/fhir/StructureDefinition/Element"/>
          </constraint>
          <mustSupport value="false"/>
          <isModifier value="false"/>
          <isSummary value="true"/>
          <mapping>
            <identity value="idmp-substance"/>
            <map
                 value="Structural_Representation.Structural_Representation_Attachment"/>
          </mapping>
        </element>
        <element id="SubstanceDefinition.structure.representation:graphic">
          <path value="SubstanceDefinition.structure.representation"/>
          <sliceName value="graphic"/>
          <short
                 value="A graphical, displayable depiction of the structure (e.g. an SVG, PNG)"/>
          <definition value="A depiction of the structure of the substance."/>
          <min value="0"/>
          <max value="1"/>
          <base>
            <path value="SubstanceDefinition.structure.representation"/>
            <min value="0"/>
            <max value="*"/>
          </base>
          <type>
            <code value="BackboneElement"/>
          </type>
          <constraint>
            <key value="ele-1"/>
            <severity value="error"/>
            <human value="All FHIR elements must have a @value or children"/>
            <expression
                        value="hasValue() or (children().count() &gt; id.count())"/>
            <source value="http://hl7.org/fhir/StructureDefinition/Element"/>
          </constraint>
          <mustSupport value="true"/>
          <isModifier value="false"/>
          <isSummary value="true"/>
          <mapping>
            <identity value="idmp-substance"/>
            <map value="Structure.Structural_Representation"/>
          </mapping>
        </element>
        <element id="SubstanceDefinition.structure.representation:graphic.id">
          <path value="SubstanceDefinition.structure.representation.id"/>
          <representation value="xmlAttr"/>
          <short value="Unique id for inter-element referencing"/>
          <definition
                      value="Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces."/>
          <min value="0"/>
          <max value="1"/>
          <base>
            <path value="Element.id"/>
            <min value="0"/>
            <max value="1"/>
          </base>
          <type>
            <extension
                       url="http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type">
              <valueUrl value="string"/>
            </extension>
            <code value="http://hl7.org/fhirpath/System.String"/>
          </type>
          <condition value="ele-1"/>
          <isModifier value="false"/>
          <isSummary value="false"/>
          <mapping>
            <identity value="rim"/>
            <map value="n/a"/>
          </mapping>
        </element>
        <element
                 id="SubstanceDefinition.structure.representation:graphic.extension">
          <path value="SubstanceDefinition.structure.representation.extension"/>
          <short value="Additional content defined by implementations"/>
          <definition
                      value="May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension."/>
          <comment
                   value="There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions.  The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone."/>
          <alias value="extensions"/>
          <alias value="user content"/>
          <min value="0"/>
          <max value="*"/>
          <base>
            <path value="Element.extension"/>
            <min value="0"/>
            <max value="*"/>
          </base>
          <type>
            <code value="Extension"/>
          </type>
          <constraint>
            <key value="ele-1"/>
            <severity value="error"/>
            <human value="All FHIR elements must have a @value or children"/>
            <expression
                        value="hasValue() or (children().count() &gt; id.count())"/>
            <source value="http://hl7.org/fhir/StructureDefinition/Element"/>
          </constraint>
          <constraint>
            <key value="ext-1"/>
            <severity value="error"/>
            <human value="Must have either extensions or value[x], not both"/>
            <expression value="extension.exists() != value.exists()"/>
            <source value="http://hl7.org/fhir/StructureDefinition/Extension"/>
          </constraint>
          <isModifier value="false"/>
          <isSummary value="false"/>
          <mapping>
            <identity value="rim"/>
            <map value="n/a"/>
          </mapping>
        </element>
        <element
                 id="SubstanceDefinition.structure.representation:graphic.modifierExtension">
          <path
                value="SubstanceDefinition.structure.representation.modifierExtension"/>
          <short value="Extensions that cannot be ignored even if unrecognized"/>
          <definition
                      value="May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.

    Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself)."/>
          <comment
                   value="There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions.  The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone."/>
          <requirements
                        value="Modifier extensions allow for extensions that *cannot* be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored.  This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the [definition of modifier extensions](http://hl7.org/fhir/R5/extensibility.html#modifierExtension)."/>
          <alias value="extensions"/>
          <alias value="user content"/>
          <alias value="modifiers"/>
          <min value="0"/>
          <max value="*"/>
          <base>
            <path value="BackboneElement.modifierExtension"/>
            <min value="0"/>
            <max value="*"/>
          </base>
          <type>
            <code value="Extension"/>
          </type>
          <constraint>
            <key value="ele-1"/>
            <severity value="error"/>
            <human value="All FHIR elements must have a @value or children"/>
            <expression
                        value="hasValue() or (children().count() &gt; id.count())"/>
            <source value="http://hl7.org/fhir/StructureDefinition/Element"/>
          </constraint>
          <constraint>
            <key value="ext-1"/>
            <severity value="error"/>
            <human value="Must have either extensions or value[x], not both"/>
            <expression value="extension.exists() != value.exists()"/>
            <source value="http://hl7.org/fhir/StructureDefinition/Extension"/>
          </constraint>
          <isModifier value="true"/>
          <isModifierReason
                            value="Modifier extensions are expected to modify the meaning or interpretation of the element that contains them"/>
          <isSummary value="true"/>
          <mapping>
            <identity value="rim"/>
            <map value="N/A"/>
          </mapping>
        </element>
        <element id="SubstanceDefinition.structure.representation:graphic.type">
          <path value="SubstanceDefinition.structure.representation.type"/>
          <short value="Graphic"/>
          <definition
                      value="The kind of structural representation (e.g. full, partial)."/>
          <min value="1"/>
          <max value="1"/>
          <base>
            <path value="SubstanceDefinition.structure.representation.type"/>
            <min value="0"/>
            <max value="1"/>
          </base>
          <type>
            <code value="CodeableConcept"/>
          </type>
          <patternCodeableConcept>
            <coding>
              <system value="http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl"/>
              <code value="C54273"/>
            </coding>
          </patternCodeableConcept>
          <constraint>
            <key value="ele-1"/>
            <severity value="error"/>
            <human value="All FHIR elements must have a @value or children"/>
            <expression
                        value="hasValue() or (children().count() &gt; id.count())"/>
            <source value="http://hl7.org/fhir/StructureDefinition/Element"/>
          </constraint>
          <mustSupport value="true"/>
          <isModifier value="false"/>
          <isSummary value="true"/>
          <binding>
            <strength value="required"/>
            <valueSet
                      value="http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-representation-types"/>
          </binding>
          <mapping>
            <identity value="idmp-substance"/>
            <map
                 value="Structural_Representation.Structural_Representation_Type"/>
          </mapping>
        </element>
        <element
                 id="SubstanceDefinition.structure.representation:graphic.representation">
          <path
                value="SubstanceDefinition.structure.representation.representation"/>
          <short
                 value="The structural representation as a text string in a standard format"/>
          <definition
                      value="The structural representation as a text string in a standard format."/>
          <min value="0"/>
          <max value="1"/>
          <base>
            <path
                  value="SubstanceDefinition.structure.representation.representation"/>
            <min value="0"/>
            <max value="1"/>
          </base>
          <type>
            <code value="string"/>
          </type>
          <constraint>
            <key value="ele-1"/>
            <severity value="error"/>
            <human value="All FHIR elements must have a @value or children"/>
            <expression
                        value="hasValue() or (children().count() &gt; id.count())"/>
            <source value="http://hl7.org/fhir/StructureDefinition/Element"/>
          </constraint>
          <mustSupport value="false"/>
          <isModifier value="false"/>
          <isSummary value="true"/>
          <mapping>
            <identity value="idmp-substance"/>
            <map value="Structural_Representation.Structural_Representation"/>
          </mapping>
        </element>
        <element
                 id="SubstanceDefinition.structure.representation:graphic.format">
          <path value="SubstanceDefinition.structure.representation.format"/>
          <short
                 value="The format of the representation e.g. InChI, SMILES, MOLFILE (note: not the physical file format)"/>
          <definition
                      value="The format of the representation e.g. InChI, SMILES, MOLFILE, CDX, SDF, PDB, mmCIF. The logical content type rather than the physical file format of a document."/>
          <min value="0"/>
          <max value="1"/>
          <base>
            <path value="SubstanceDefinition.structure.representation.format"/>
            <min value="0"/>
            <max value="1"/>
          </base>
          <type>
            <code value="CodeableConcept"/>
          </type>
          <constraint>
            <key value="ele-1"/>
            <severity value="error"/>
            <human value="All FHIR elements must have a @value or children"/>
            <expression
                        value="hasValue() or (children().count() &gt; id.count())"/>
            <source value="http://hl7.org/fhir/StructureDefinition/Element"/>
          </constraint>
          <mustSupport value="false"/>
          <isModifier value="false"/>
          <isSummary value="true"/>
          <binding>
            <extension
                       url="http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName">
              <valueString value="SubstanceRepresentationFormat"/>
            </extension>
            <strength value="example"/>
            <description value="A format of a substance representation."/>
            <valueSet
                      value="http://hl7.org/fhir/ValueSet/substance-representation-format"/>
          </binding>
          <mapping>
            <identity value="idmp-substance"/>
            <map value="n/a"/>
          </mapping>
        </element>
        <element
                 id="SubstanceDefinition.structure.representation:graphic.document">
          <path value="SubstanceDefinition.structure.representation.document"/>
          <short value="Impurity Structure Graphic"/>
          <definition
                      value="A pictorial representation of the structure of the impurity substance.
    [Source: SME Defined] Note: Refer to the 'Acceptable File Formats for
    use in eCTD' Example: This is the representation of the molecule CH3OH,
    or the sequence SHLVEALALVAGERG."/>
          <min value="1"/>
          <max value="1"/>
          <base>
            <path value="SubstanceDefinition.structure.representation.document"/>
            <min value="0"/>
            <max value="1"/>
          </base>
          <type>
            <code value="Reference"/>
            <profile
                     value="http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/literal-reference"/>
            <targetProfile
                           value="http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pqcmc-graphic-reference"/>
            <aggregation value="bundled"/>
          </type>
          <constraint>
            <key value="ele-1"/>
            <severity value="error"/>
            <human value="All FHIR elements must have a @value or children"/>
            <expression
                        value="hasValue() or (children().count() &gt; id.count())"/>
            <source value="http://hl7.org/fhir/StructureDefinition/Element"/>
          </constraint>
          <mustSupport value="false"/>
          <isModifier value="false"/>
          <isSummary value="true"/>
          <mapping>
            <identity value="idmp-substance"/>
            <map
                 value="Structural_Representation.Structural_Representation_Attachment"/>
          </mapping>
        </element>
        <element id="SubstanceDefinition.structure.representation:structureFile">
          <path value="SubstanceDefinition.structure.representation"/>
          <sliceName value="structureFile"/>
          <short value="machine-readable representation -- attached file"/>
          <definition value="A depiction of the structure of the substance."/>
          <min value="0"/>
          <max value="*"/>
          <base>
            <path value="SubstanceDefinition.structure.representation"/>
            <min value="0"/>
            <max value="*"/>
          </base>
          <type>
            <code value="BackboneElement"/>
          </type>
          <constraint>
            <key value="ele-1"/>
            <severity value="error"/>
            <human value="All FHIR elements must have a @value or children"/>
            <expression
                        value="hasValue() or (children().count() &gt; id.count())"/>
            <source value="http://hl7.org/fhir/StructureDefinition/Element"/>
          </constraint>
          <mustSupport value="true"/>
          <isModifier value="false"/>
          <isSummary value="true"/>
          <mapping>
            <identity value="idmp-substance"/>
            <map value="Structure.Structural_Representation"/>
          </mapping>
        </element>
        <element
                 id="SubstanceDefinition.structure.representation:structureFile.id">
          <path value="SubstanceDefinition.structure.representation.id"/>
          <representation value="xmlAttr"/>
          <short value="Unique id for inter-element referencing"/>
          <definition
                      value="Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces."/>
          <min value="0"/>
          <max value="1"/>
          <base>
            <path value="Element.id"/>
            <min value="0"/>
            <max value="1"/>
          </base>
          <type>
            <extension
                       url="http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type">
              <valueUrl value="string"/>
            </extension>
            <code value="http://hl7.org/fhirpath/System.String"/>
          </type>
          <condition value="ele-1"/>
          <isModifier value="false"/>
          <isSummary value="false"/>
          <mapping>
            <identity value="rim"/>
            <map value="n/a"/>
          </mapping>
        </element>
        <element
                 id="SubstanceDefinition.structure.representation:structureFile.extension">
          <path value="SubstanceDefinition.structure.representation.extension"/>
          <short value="Additional content defined by implementations"/>
          <definition
                      value="May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension."/>
          <comment
                   value="There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions.  The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone."/>
          <alias value="extensions"/>
          <alias value="user content"/>
          <min value="0"/>
          <max value="*"/>
          <base>
            <path value="Element.extension"/>
            <min value="0"/>
            <max value="*"/>
          </base>
          <type>
            <code value="Extension"/>
          </type>
          <constraint>
            <key value="ele-1"/>
            <severity value="error"/>
            <human value="All FHIR elements must have a @value or children"/>
            <expression
                        value="hasValue() or (children().count() &gt; id.count())"/>
            <source value="http://hl7.org/fhir/StructureDefinition/Element"/>
          </constraint>
          <constraint>
            <key value="ext-1"/>
            <severity value="error"/>
            <human value="Must have either extensions or value[x], not both"/>
            <expression value="extension.exists() != value.exists()"/>
            <source value="http://hl7.org/fhir/StructureDefinition/Extension"/>
          </constraint>
          <isModifier value="false"/>
          <isSummary value="false"/>
          <mapping>
            <identity value="rim"/>
            <map value="n/a"/>
          </mapping>
        </element>
        <element
                 id="SubstanceDefinition.structure.representation:structureFile.modifierExtension">
          <path
                value="SubstanceDefinition.structure.representation.modifierExtension"/>
          <short value="Extensions that cannot be ignored even if unrecognized"/>
          <definition
                      value="May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.

    Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself)."/>
          <comment
                   value="There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions.  The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone."/>
          <requirements
                        value="Modifier extensions allow for extensions that *cannot* be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored.  This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the [definition of modifier extensions](http://hl7.org/fhir/R5/extensibility.html#modifierExtension)."/>
          <alias value="extensions"/>
          <alias value="user content"/>
          <alias value="modifiers"/>
          <min value="0"/>
          <max value="*"/>
          <base>
            <path value="BackboneElement.modifierExtension"/>
            <min value="0"/>
            <max value="*"/>
          </base>
          <type>
            <code value="Extension"/>
          </type>
          <constraint>
            <key value="ele-1"/>
            <severity value="error"/>
            <human value="All FHIR elements must have a @value or children"/>
            <expression
                        value="hasValue() or (children().count() &gt; id.count())"/>
            <source value="http://hl7.org/fhir/StructureDefinition/Element"/>
          </constraint>
          <constraint>
            <key value="ext-1"/>
            <severity value="error"/>
            <human value="Must have either extensions or value[x], not both"/>
            <expression value="extension.exists() != value.exists()"/>
            <source value="http://hl7.org/fhir/StructureDefinition/Extension"/>
          </constraint>
          <isModifier value="true"/>
          <isModifierReason
                            value="Modifier extensions are expected to modify the meaning or interpretation of the element that contains them"/>
          <isSummary value="true"/>
          <mapping>
            <identity value="rim"/>
            <map value="N/A"/>
          </mapping>
        </element>
        <element
                 id="SubstanceDefinition.structure.representation:structureFile.type">
          <path value="SubstanceDefinition.structure.representation.type"/>
          <short value="Structure File"/>
          <definition
                      value="The kind of structural representation (e.g. full, partial)."/>
          <min value="1"/>
          <max value="1"/>
          <base>
            <path value="SubstanceDefinition.structure.representation.type"/>
            <min value="0"/>
            <max value="1"/>
          </base>
          <type>
            <code value="CodeableConcept"/>
          </type>
          <patternCodeableConcept>
            <coding>
              <system value="http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl"/>
              <code value="C103240"/>
            </coding>
          </patternCodeableConcept>
          <constraint>
            <key value="ele-1"/>
            <severity value="error"/>
            <human value="All FHIR elements must have a @value or children"/>
            <expression
                        value="hasValue() or (children().count() &gt; id.count())"/>
            <source value="http://hl7.org/fhir/StructureDefinition/Element"/>
          </constraint>
          <mustSupport value="true"/>
          <isModifier value="false"/>
          <isSummary value="true"/>
          <binding>
            <strength value="required"/>
            <valueSet
                      value="http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-representation-types"/>
          </binding>
          <mapping>
            <identity value="idmp-substance"/>
            <map
                 value="Structural_Representation.Structural_Representation_Type"/>
          </mapping>
        </element>
        <element
                 id="SubstanceDefinition.structure.representation:structureFile.representation">
          <path
                value="SubstanceDefinition.structure.representation.representation"/>
          <short
                 value="The structural representation as a text string in a standard format"/>
          <definition
                      value="The structural representation as a text string in a standard format."/>
          <min value="0"/>
          <max value="1"/>
          <base>
            <path
                  value="SubstanceDefinition.structure.representation.representation"/>
            <min value="0"/>
            <max value="1"/>
          </base>
          <type>
            <code value="string"/>
          </type>
          <constraint>
            <key value="ele-1"/>
            <severity value="error"/>
            <human value="All FHIR elements must have a @value or children"/>
            <expression
                        value="hasValue() or (children().count() &gt; id.count())"/>
            <source value="http://hl7.org/fhir/StructureDefinition/Element"/>
          </constraint>
          <mustSupport value="false"/>
          <isModifier value="false"/>
          <isSummary value="true"/>
          <mapping>
            <identity value="idmp-substance"/>
            <map value="Structural_Representation.Structural_Representation"/>
          </mapping>
        </element>
        <element
                 id="SubstanceDefinition.structure.representation:structureFile.format">
          <path value="SubstanceDefinition.structure.representation.format"/>
          <short
                 value="The format of the representation e.g. InChI, SMILES, MOLFILE (note: not the physical file format)"/>
          <definition
                      value="The format of the representation e.g. InChI, SMILES, MOLFILE, CDX, SDF, PDB, mmCIF. The logical content type rather than the physical file format of a document."/>
          <min value="0"/>
          <max value="1"/>
          <base>
            <path value="SubstanceDefinition.structure.representation.format"/>
            <min value="0"/>
            <max value="1"/>
          </base>
          <type>
            <code value="CodeableConcept"/>
          </type>
          <constraint>
            <key value="ele-1"/>
            <severity value="error"/>
            <human value="All FHIR elements must have a @value or children"/>
            <expression
                        value="hasValue() or (children().count() &gt; id.count())"/>
            <source value="http://hl7.org/fhir/StructureDefinition/Element"/>
          </constraint>
          <mustSupport value="false"/>
          <isModifier value="false"/>
          <isSummary value="true"/>
          <binding>
            <extension
                       url="http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName">
              <valueString value="SubstanceRepresentationFormat"/>
            </extension>
            <strength value="example"/>
            <description value="A format of a substance representation."/>
            <valueSet
                      value="http://hl7.org/fhir/ValueSet/substance-representation-format"/>
          </binding>
          <mapping>
            <identity value="idmp-substance"/>
            <map value="n/a"/>
          </mapping>
        </element>
        <element
                 id="SubstanceDefinition.structure.representation:structureFile.document">
          <path value="SubstanceDefinition.structure.representation.document"/>
          <short
                 value="Impurity Chemical Structure Data (files, e.g. .SDF, .CIF)"/>
          <definition
                      value="An attached file with the structural representation e.g. a molecular structure graphic of the substance, a JCAMP or AnIML file."/>
          <min value="1"/>
          <max value="1"/>
          <base>
            <path value="SubstanceDefinition.structure.representation.document"/>
            <min value="0"/>
            <max value="1"/>
          </base>
          <type>
            <code value="Reference"/>
            <profile
                     value="http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/literal-reference"/>
            <targetProfile
                           value="http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pqcmc-structure-reference"/>
            <aggregation value="bundled"/>
          </type>
          <constraint>
            <key value="ele-1"/>
            <severity value="error"/>
            <human value="All FHIR elements must have a @value or children"/>
            <expression
                        value="hasValue() or (children().count() &gt; id.count())"/>
            <source value="http://hl7.org/fhir/StructureDefinition/Element"/>
          </constraint>
          <mustSupport value="true"/>
          <isModifier value="false"/>
          <isSummary value="true"/>
          <mapping>
            <identity value="idmp-substance"/>
            <map
                 value="Structural_Representation.Structural_Representation_Attachment"/>
          </mapping>
        </element>
        <element
                 id="SubstanceDefinition.structure.representation:structureString">
          <path value="SubstanceDefinition.structure.representation"/>
          <sliceName value="structureString"/>
          <short value="machine-readable representation -- plain text"/>
          <definition value="A depiction of the structure of the substance."/>
          <min value="0"/>
          <max value="*"/>
          <base>
            <path value="SubstanceDefinition.structure.representation"/>
            <min value="0"/>
            <max value="*"/>
          </base>
          <type>
            <code value="BackboneElement"/>
          </type>
          <constraint>
            <key value="ele-1"/>
            <severity value="error"/>
            <human value="All FHIR elements must have a @value or children"/>
            <expression
                        value="hasValue() or (children().count() &gt; id.count())"/>
            <source value="http://hl7.org/fhir/StructureDefinition/Element"/>
          </constraint>
          <mustSupport value="true"/>
          <isModifier value="false"/>
          <isSummary value="true"/>
          <mapping>
            <identity value="idmp-substance"/>
            <map value="Structure.Structural_Representation"/>
          </mapping>
        </element>
        <element
                 id="SubstanceDefinition.structure.representation:structureString.id">
          <path value="SubstanceDefinition.structure.representation.id"/>
          <representation value="xmlAttr"/>
          <short value="Unique id for inter-element referencing"/>
          <definition
                      value="Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces."/>
          <min value="0"/>
          <max value="1"/>
          <base>
            <path value="Element.id"/>
            <min value="0"/>
            <max value="1"/>
          </base>
          <type>
            <extension
                       url="http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type">
              <valueUrl value="string"/>
            </extension>
            <code value="http://hl7.org/fhirpath/System.String"/>
          </type>
          <condition value="ele-1"/>
          <isModifier value="false"/>
          <isSummary value="false"/>
          <mapping>
            <identity value="rim"/>
            <map value="n/a"/>
          </mapping>
        </element>
        <element
                 id="SubstanceDefinition.structure.representation:structureString.extension">
          <path value="SubstanceDefinition.structure.representation.extension"/>
          <short value="Additional content defined by implementations"/>
          <definition
                      value="May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension."/>
          <comment
                   value="There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions.  The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone."/>
          <alias value="extensions"/>
          <alias value="user content"/>
          <min value="0"/>
          <max value="*"/>
          <base>
            <path value="Element.extension"/>
            <min value="0"/>
            <max value="*"/>
          </base>
          <type>
            <code value="Extension"/>
          </type>
          <constraint>
            <key value="ele-1"/>
            <severity value="error"/>
            <human value="All FHIR elements must have a @value or children"/>
            <expression
                        value="hasValue() or (children().count() &gt; id.count())"/>
            <source value="http://hl7.org/fhir/StructureDefinition/Element"/>
          </constraint>
          <constraint>
            <key value="ext-1"/>
            <severity value="error"/>
            <human value="Must have either extensions or value[x], not both"/>
            <expression value="extension.exists() != value.exists()"/>
            <source value="http://hl7.org/fhir/StructureDefinition/Extension"/>
          </constraint>
          <isModifier value="false"/>
          <isSummary value="false"/>
          <mapping>
            <identity value="rim"/>
            <map value="n/a"/>
          </mapping>
        </element>
        <element
                 id="SubstanceDefinition.structure.representation:structureString.modifierExtension">
          <path
                value="SubstanceDefinition.structure.representation.modifierExtension"/>
          <short value="Extensions that cannot be ignored even if unrecognized"/>
          <definition
                      value="May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.

    Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself)."/>
          <comment
                   value="There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions.  The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone."/>
          <requirements
                        value="Modifier extensions allow for extensions that *cannot* be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored.  This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the [definition of modifier extensions](http://hl7.org/fhir/R5/extensibility.html#modifierExtension)."/>
          <alias value="extensions"/>
          <alias value="user content"/>
          <alias value="modifiers"/>
          <min value="0"/>
          <max value="*"/>
          <base>
            <path value="BackboneElement.modifierExtension"/>
            <min value="0"/>
            <max value="*"/>
          </base>
          <type>
            <code value="Extension"/>
          </type>
          <constraint>
            <key value="ele-1"/>
            <severity value="error"/>
            <human value="All FHIR elements must have a @value or children"/>
            <expression
                        value="hasValue() or (children().count() &gt; id.count())"/>
            <source value="http://hl7.org/fhir/StructureDefinition/Element"/>
          </constraint>
          <constraint>
            <key value="ext-1"/>
            <severity value="error"/>
            <human value="Must have either extensions or value[x], not both"/>
            <expression value="extension.exists() != value.exists()"/>
            <source value="http://hl7.org/fhir/StructureDefinition/Extension"/>
          </constraint>
          <isModifier value="true"/>
          <isModifierReason
                            value="Modifier extensions are expected to modify the meaning or interpretation of the element that contains them"/>
          <isSummary value="true"/>
          <mapping>
            <identity value="rim"/>
            <map value="N/A"/>
          </mapping>
        </element>
        <element
                 id="SubstanceDefinition.structure.representation:structureString.type">
          <path value="SubstanceDefinition.structure.representation.type"/>
          <short value="Structure Textual"/>
          <definition
                      value="The kind of structural representation (e.g. full, partial)."/>
          <min value="1"/>
          <max value="1"/>
          <base>
            <path value="SubstanceDefinition.structure.representation.type"/>
            <min value="0"/>
            <max value="1"/>
          </base>
          <type>
            <code value="CodeableConcept"/>
          </type>
          <patternCodeableConcept>
            <coding>
              <system value="http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl"/>
              <code value="C45253"/>
            </coding>
          </patternCodeableConcept>
          <constraint>
            <key value="ele-1"/>
            <severity value="error"/>
            <human value="All FHIR elements must have a @value or children"/>
            <expression
                        value="hasValue() or (children().count() &gt; id.count())"/>
            <source value="http://hl7.org/fhir/StructureDefinition/Element"/>
          </constraint>
          <mustSupport value="true"/>
          <isModifier value="false"/>
          <isSummary value="true"/>
          <binding>
            <strength value="required"/>
            <valueSet
                      value="http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-representation-types"/>
          </binding>
          <mapping>
            <identity value="idmp-substance"/>
            <map
                 value="Structural_Representation.Structural_Representation_Type"/>
          </mapping>
        </element>
        <element
                 id="SubstanceDefinition.structure.representation:structureString.representation">
          <path
                value="SubstanceDefinition.structure.representation.representation"/>
          <short
                 value="Impurity Chemical Structure Data (short, plain text representations, e.g. SMILES)"/>
          <definition
                      value="A machine-readable representation of the structure of the chemical. [Source: SME Defined]
    Examples: SMILES, INCHI"/>
          <min value="1"/>
          <max value="1"/>
          <base>
            <path
                  value="SubstanceDefinition.structure.representation.representation"/>
            <min value="0"/>
            <max value="1"/>
          </base>
          <type>
            <code value="string"/>
          </type>
          <constraint>
            <key value="ele-1"/>
            <severity value="error"/>
            <human value="All FHIR elements must have a @value or children"/>
            <expression
                        value="hasValue() or (children().count() &gt; id.count())"/>
            <source value="http://hl7.org/fhir/StructureDefinition/Element"/>
          </constraint>
          <mustSupport value="true"/>
          <isModifier value="false"/>
          <isSummary value="true"/>
          <mapping>
            <identity value="idmp-substance"/>
            <map value="Structural_Representation.Structural_Representation"/>
          </mapping>
        </element>
        <element
                 id="SubstanceDefinition.structure.representation:structureString.format">
          <path value="SubstanceDefinition.structure.representation.format"/>
          <short value="Drug Substance Impurity Method Type"/>
          <definition
                      value="The format of the representation e.g. InChI, SMILES, MOLFILE, CDX, SDF, PDB, mmCIF. The logical content type rather than the physical file format of a document."/>
          <min value="1"/>
          <max value="1"/>
          <base>
            <path value="SubstanceDefinition.structure.representation.format"/>
            <min value="0"/>
            <max value="1"/>
          </base>
          <type>
            <code value="CodeableConcept"/>
          </type>
          <constraint>
            <key value="ele-1"/>
            <severity value="error"/>
            <human value="All FHIR elements must have a @value or children"/>
            <expression
                        value="hasValue() or (children().count() &gt; id.count())"/>
            <source value="http://hl7.org/fhir/StructureDefinition/Element"/>
          </constraint>
          <mustSupport value="true"/>
          <isModifier value="false"/>
          <isSummary value="true"/>
          <binding>
            <strength value="required"/>
            <valueSet
                      value="http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-chemical-structure-datafile-type-terminology"/>
          </binding>
          <mapping>
            <identity value="idmp-substance"/>
            <map value="n/a"/>
          </mapping>
        </element>
        <element
                 id="SubstanceDefinition.structure.representation:structureString.document">
          <path value="SubstanceDefinition.structure.representation.document"/>
          <short
                 value="An attachment with the structural representation e.g. a structure graphic or AnIML file"/>
          <definition
                      value="An attached file with the structural representation e.g. a molecular structure graphic of the substance, a JCAMP or AnIML file."/>
          <min value="0"/>
          <max value="1"/>
          <base>
            <path value="SubstanceDefinition.structure.representation.document"/>
            <min value="0"/>
            <max value="1"/>
          </base>
          <type>
            <code value="Reference"/>
            <targetProfile
                           value="http://hl7.org/fhir/StructureDefinition/DocumentReference"/>
          </type>
          <constraint>
            <key value="ele-1"/>
            <severity value="error"/>
            <human value="All FHIR elements must have a @value or children"/>
            <expression
                        value="hasValue() or (children().count() &gt; id.count())"/>
            <source value="http://hl7.org/fhir/StructureDefinition/Element"/>
          </constraint>
          <mustSupport value="false"/>
          <isModifier value="false"/>
          <isSummary value="true"/>
          <mapping>
            <identity value="idmp-substance"/>
            <map
                 value="Structural_Representation.Structural_Representation_Attachment"/>
          </mapping>
        </element>
        <element id="SubstanceDefinition.code">
          <path value="SubstanceDefinition.code"/>
          <slicing>
            <discriminator>
              <type value="value"/>
              <path value="code.coding.system"/>
            </discriminator>
            <rules value="open"/>
          </slicing>
          <short value="Codes associated with the substance"/>
          <definition value="Codes associated with the substance."/>
          <min value="1"/>
          <max value="*"/>
          <base>
            <path value="SubstanceDefinition.code"/>
            <min value="0"/>
            <max value="*"/>
          </base>
          <type>
            <code value="BackboneElement"/>
          </type>
          <constraint>
            <key value="ele-1"/>
            <severity value="error"/>
            <human value="All FHIR elements must have a @value or children"/>
            <expression
                        value="hasValue() or (children().count() &gt; id.count())"/>
            <source value="http://hl7.org/fhir/StructureDefinition/Element"/>
          </constraint>
          <mustSupport value="true"/>
          <isModifier value="false"/>
          <isSummary value="true"/>
          <mapping>
            <identity value="idmp-substance"/>
            <map value="Substance.Substance_Code"/>
          </mapping>
        </element>
        <element id="SubstanceDefinition.code.id">
          <path value="SubstanceDefinition.code.id"/>
          <representation value="xmlAttr"/>
          <short value="Unique id for inter-element referencing"/>
          <definition
                      value="Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces."/>
          <min value="0"/>
          <max value="1"/>
          <base>
            <path value="Element.id"/>
            <min value="0"/>
            <max value="1"/>
          </base>
          <type>
            <extension
                       url="http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type">
              <valueUrl value="string"/>
            </extension>
            <code value="http://hl7.org/fhirpath/System.String"/>
          </type>
          <condition value="ele-1"/>
          <isModifier value="false"/>
          <isSummary value="false"/>
          <mapping>
            <identity value="rim"/>
            <map value="n/a"/>
          </mapping>
        </element>
        <element id="SubstanceDefinition.code.extension">
          <path value="SubstanceDefinition.code.extension"/>
          <short value="Additional content defined by implementations"/>
          <definition
                      value="May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension."/>
          <comment
                   value="There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions.  The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone."/>
          <alias value="extensions"/>
          <alias value="user content"/>
          <min value="0"/>
          <max value="*"/>
          <base>
            <path value="Element.extension"/>
            <min value="0"/>
            <max value="*"/>
          </base>
          <type>
            <code value="Extension"/>
          </type>
          <constraint>
            <key value="ele-1"/>
            <severity value="error"/>
            <human value="All FHIR elements must have a @value or children"/>
            <expression
                        value="hasValue() or (children().count() &gt; id.count())"/>
            <source value="http://hl7.org/fhir/StructureDefinition/Element"/>
          </constraint>
          <constraint>
            <key value="ext-1"/>
            <severity value="error"/>
            <human value="Must have either extensions or value[x], not both"/>
            <expression value="extension.exists() != value.exists()"/>
            <source value="http://hl7.org/fhir/StructureDefinition/Extension"/>
          </constraint>
          <isModifier value="false"/>
          <isSummary value="false"/>
          <mapping>
            <identity value="rim"/>
            <map value="n/a"/>
          </mapping>
        </element>
        <element id="SubstanceDefinition.code.modifierExtension">
          <path value="SubstanceDefinition.code.modifierExtension"/>
          <short value="Extensions that cannot be ignored even if unrecognized"/>
          <definition
                      value="May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.

    Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself)."/>
          <comment
                   value="There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions.  The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone."/>
          <requirements
                        value="Modifier extensions allow for extensions that *cannot* be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored.  This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the [definition of modifier extensions](http://hl7.org/fhir/R5/extensibility.html#modifierExtension)."/>
          <alias value="extensions"/>
          <alias value="user content"/>
          <alias value="modifiers"/>
          <min value="0"/>
          <max value="*"/>
          <base>
            <path value="BackboneElement.modifierExtension"/>
            <min value="0"/>
            <max value="*"/>
          </base>
          <type>
            <code value="Extension"/>
          </type>
          <constraint>
            <key value="ele-1"/>
            <severity value="error"/>
            <human value="All FHIR elements must have a @value or children"/>
            <expression
                        value="hasValue() or (children().count() &gt; id.count())"/>
            <source value="http://hl7.org/fhir/StructureDefinition/Element"/>
          </constraint>
          <constraint>
            <key value="ext-1"/>
            <severity value="error"/>
            <human value="Must have either extensions or value[x], not both"/>
            <expression value="extension.exists() != value.exists()"/>
            <source value="http://hl7.org/fhir/StructureDefinition/Extension"/>
          </constraint>
          <isModifier value="true"/>
          <isModifierReason
                            value="Modifier extensions are expected to modify the meaning or interpretation of the element that contains them"/>
          <isSummary value="true"/>
          <mapping>
            <identity value="rim"/>
            <map value="N/A"/>
          </mapping>
        </element>
        <element id="SubstanceDefinition.code.code">
          <path value="SubstanceDefinition.code.code"/>
          <short value="The specific code"/>
          <definition value="The specific code."/>
          <min value="0"/>
          <max value="1"/>
          <base>
            <path value="SubstanceDefinition.code.code"/>
            <min value="0"/>
            <max value="1"/>
          </base>
          <type>
            <code value="CodeableConcept"/>
          </type>
          <constraint>
            <key value="ele-1"/>
            <severity value="error"/>
            <human value="All FHIR elements must have a @value or children"/>
            <expression
                        value="hasValue() or (children().count() &gt; id.count())"/>
            <source value="http://hl7.org/fhir/StructureDefinition/Element"/>
          </constraint>
          <mustSupport value="false"/>
          <isModifier value="false"/>
          <isSummary value="true"/>
          <mapping>
            <identity value="idmp-substance"/>
            <map
                 value="Substance_Code.Code, Substance_Code.Code_System, Substance_Code.Code_System_Id"/>
          </mapping>
        </element>
        <element id="SubstanceDefinition.code.status">
          <path value="SubstanceDefinition.code.status"/>
          <short
                 value="Status of the code assignment, for example 'provisional', 'approved'"/>
          <definition
                      value="Status of the code assignment, for example 'provisional', 'approved'."/>
          <min value="0"/>
          <max value="1"/>
          <base>
            <path value="SubstanceDefinition.code.status"/>
            <min value="0"/>
            <max value="1"/>
          </base>
          <type>
            <code value="CodeableConcept"/>
          </type>
          <constraint>
            <key value="ele-1"/>
            <severity value="error"/>
            <human value="All FHIR elements must have a @value or children"/>
            <expression
                        value="hasValue() or (children().count() &gt; id.count())"/>
            <source value="http://hl7.org/fhir/StructureDefinition/Element"/>
          </constraint>
          <mustSupport value="false"/>
          <isModifier value="false"/>
          <isSummary value="true"/>
          <binding>
            <extension
                       url="http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName">
              <valueString value="PublicationStatus"/>
            </extension>
            <strength value="preferred"/>
            <description value="The lifecycle status of an artifact."/>
            <valueSet value="http://hl7.org/fhir/ValueSet/publication-status"/>
          </binding>
          <mapping>
            <identity value="idmp-substance"/>
            <map value="Substance_Code.Code_System_Status"/>
          </mapping>
        </element>
        <element id="SubstanceDefinition.code.statusDate">
          <path value="SubstanceDefinition.code.statusDate"/>
          <short value="The date at which the code status was changed"/>
          <definition
                      value="The date at which the code status was changed as part of the terminology maintenance."/>
          <min value="0"/>
          <max value="1"/>
          <base>
            <path value="SubstanceDefinition.code.statusDate"/>
            <min value="0"/>
            <max value="1"/>
          </base>
          <type>
            <code value="dateTime"/>
          </type>
          <constraint>
            <key value="ele-1"/>
            <severity value="error"/>
            <human value="All FHIR elements must have a @value or children"/>
            <expression
                        value="hasValue() or (children().count() &gt; id.count())"/>
            <source value="http://hl7.org/fhir/StructureDefinition/Element"/>
          </constraint>
          <mustSupport value="false"/>
          <isModifier value="false"/>
          <isSummary value="true"/>
          <mapping>
            <identity value="idmp-substance"/>
            <map value="Substance_Code.Code_Change_Date"/>
          </mapping>
        </element>
        <element id="SubstanceDefinition.code.note">
          <path value="SubstanceDefinition.code.note"/>
          <short value="Any comment can be provided in this field"/>
          <definition
                      value="Any comment can be provided in this field, if necessary."/>
          <min value="0"/>
          <max value="*"/>
          <base>
            <path value="SubstanceDefinition.code.note"/>
            <min value="0"/>
            <max value="*"/>
          </base>
          <type>
            <code value="Annotation"/>
          </type>
          <constraint>
            <key value="ele-1"/>
            <severity value="error"/>
            <human value="All FHIR elements must have a @value or children"/>
            <expression
                        value="hasValue() or (children().count() &gt; id.count())"/>
            <source value="http://hl7.org/fhir/StructureDefinition/Element"/>
          </constraint>
          <mustSupport value="false"/>
          <isModifier value="false"/>
          <isSummary value="true"/>
          <mapping>
            <identity value="idmp-substance"/>
            <map value="Substance_Code.Comment"/>
          </mapping>
        </element>
        <element id="SubstanceDefinition.code.source">
          <path value="SubstanceDefinition.code.source"/>
          <short value="Supporting literature"/>
          <definition value="Supporting literature."/>
          <min value="0"/>
          <max value="*"/>
          <base>
            <path value="SubstanceDefinition.code.source"/>
            <min value="0"/>
            <max value="*"/>
          </base>
          <type>
            <code value="Reference"/>
            <targetProfile
                           value="http://hl7.org/fhir/StructureDefinition/DocumentReference"/>
          </type>
          <constraint>
            <key value="ele-1"/>
            <severity value="error"/>
            <human value="All FHIR elements must have a @value or children"/>
            <expression
                        value="hasValue() or (children().count() &gt; id.count())"/>
            <source value="http://hl7.org/fhir/StructureDefinition/Element"/>
          </constraint>
          <mustSupport value="false"/>
          <isModifier value="false"/>
          <isSummary value="true"/>
          <mapping>
            <identity value="idmp-substance"/>
            <map value="Substance_Code.Reference_Source"/>
          </mapping>
        </element>
        <element id="SubstanceDefinition.code:unii">
          <path value="SubstanceDefinition.code"/>
          <sliceName value="unii"/>
          <short value="UNII"/>
          <definition
                      value="The UNII is a non-proprietary, free, unique, unambiguous, non-semantic, alphanumeric identifier based on a substance’s molecular structure and/or descriptive information. [Source: http://www.fda.gov/ForIndustry/DataStandards/SubstanceRegistrationSystem-UniqueIngredientIdentifierUNII/]
    Example: 362O9ITL9D
    Note: If a UNII does not exist, please go to http://www.fda.gov/ForIndustry/DataStandards/SubstanceRegistrationSystem-UniqueIngredientIdentifierUNII/"/>
          <min value="0"/>
          <max value="1"/>
          <base>
            <path value="SubstanceDefinition.code"/>
            <min value="0"/>
            <max value="*"/>
          </base>
          <type>
            <code value="BackboneElement"/>
          </type>
          <constraint>
            <key value="ele-1"/>
            <severity value="error"/>
            <human value="All FHIR elements must have a @value or children"/>
            <expression
                        value="hasValue() or (children().count() &gt; id.count())"/>
            <source value="http://hl7.org/fhir/StructureDefinition/Element"/>
          </constraint>
          <mustSupport value="true"/>
          <isModifier value="false"/>
          <isSummary value="true"/>
          <mapping>
            <identity value="idmp-substance"/>
            <map value="Substance.Substance_Code"/>
          </mapping>
        </element>
        <element id="SubstanceDefinition.code:unii.id">
          <path value="SubstanceDefinition.code.id"/>
          <representation value="xmlAttr"/>
          <short value="Unique id for inter-element referencing"/>
          <definition
                      value="Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces."/>
          <min value="0"/>
          <max value="1"/>
          <base>
            <path value="Element.id"/>
            <min value="0"/>
            <max value="1"/>
          </base>
          <type>
            <extension
                       url="http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type">
              <valueUrl value="string"/>
            </extension>
            <code value="http://hl7.org/fhirpath/System.String"/>
          </type>
          <condition value="ele-1"/>
          <isModifier value="false"/>
          <isSummary value="false"/>
          <mapping>
            <identity value="rim"/>
            <map value="n/a"/>
          </mapping>
        </element>
        <element id="SubstanceDefinition.code:unii.extension">
          <path value="SubstanceDefinition.code.extension"/>
          <short value="Additional content defined by implementations"/>
          <definition
                      value="May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension."/>
          <comment
                   value="There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions.  The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone."/>
          <alias value="extensions"/>
          <alias value="user content"/>
          <min value="0"/>
          <max value="*"/>
          <base>
            <path value="Element.extension"/>
            <min value="0"/>
            <max value="*"/>
          </base>
          <type>
            <code value="Extension"/>
          </type>
          <constraint>
            <key value="ele-1"/>
            <severity value="error"/>
            <human value="All FHIR elements must have a @value or children"/>
            <expression
                        value="hasValue() or (children().count() &gt; id.count())"/>
            <source value="http://hl7.org/fhir/StructureDefinition/Element"/>
          </constraint>
          <constraint>
            <key value="ext-1"/>
            <severity value="error"/>
            <human value="Must have either extensions or value[x], not both"/>
            <expression value="extension.exists() != value.exists()"/>
            <source value="http://hl7.org/fhir/StructureDefinition/Extension"/>
          </constraint>
          <isModifier value="false"/>
          <isSummary value="false"/>
          <mapping>
            <identity value="rim"/>
            <map value="n/a"/>
          </mapping>
        </element>
        <element id="SubstanceDefinition.code:unii.modifierExtension">
          <path value="SubstanceDefinition.code.modifierExtension"/>
          <short value="Extensions that cannot be ignored even if unrecognized"/>
          <definition
                      value="May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.

    Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself)."/>
          <comment
                   value="There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions.  The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone."/>
          <requirements
                        value="Modifier extensions allow for extensions that *cannot* be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored.  This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the [definition of modifier extensions](http://hl7.org/fhir/R5/extensibility.html#modifierExtension)."/>
          <alias value="extensions"/>
          <alias value="user content"/>
          <alias value="modifiers"/>
          <min value="0"/>
          <max value="*"/>
          <base>
            <path value="BackboneElement.modifierExtension"/>
            <min value="0"/>
            <max value="*"/>
          </base>
          <type>
            <code value="Extension"/>
          </type>
          <constraint>
            <key value="ele-1"/>
            <severity value="error"/>
            <human value="All FHIR elements must have a @value or children"/>
            <expression
                        value="hasValue() or (children().count() &gt; id.count())"/>
            <source value="http://hl7.org/fhir/StructureDefinition/Element"/>
          </constraint>
          <constraint>
            <key value="ext-1"/>
            <severity value="error"/>
            <human value="Must have either extensions or value[x], not both"/>
            <expression value="extension.exists() != value.exists()"/>
            <source value="http://hl7.org/fhir/StructureDefinition/Extension"/>
          </constraint>
          <isModifier value="true"/>
          <isModifierReason
                            value="Modifier extensions are expected to modify the meaning or interpretation of the element that contains them"/>
          <isSummary value="true"/>
          <mapping>
            <identity value="rim"/>
            <map value="N/A"/>
          </mapping>
        </element>
        <element id="SubstanceDefinition.code:unii.code">
          <path value="SubstanceDefinition.code.code"/>
          <short value="The specific code"/>
          <definition value="The specific code."/>
          <min value="1"/>
          <max value="1"/>
          <base>
            <path value="SubstanceDefinition.code.code"/>
            <min value="0"/>
            <max value="1"/>
          </base>
          <type>
            <code value="CodeableConcept"/>
          </type>
          <constraint>
            <key value="ele-1"/>
            <severity value="error"/>
            <human value="All FHIR elements must have a @value or children"/>
            <expression
                        value="hasValue() or (children().count() &gt; id.count())"/>
            <source value="http://hl7.org/fhir/StructureDefinition/Element"/>
          </constraint>
          <mustSupport value="true"/>
          <isModifier value="false"/>
          <isSummary value="true"/>
          <mapping>
            <identity value="idmp-substance"/>
            <map
                 value="Substance_Code.Code, Substance_Code.Code_System, Substance_Code.Code_System_Id"/>
          </mapping>
        </element>
        <element id="SubstanceDefinition.code:unii.code.id">
          <path value="SubstanceDefinition.code.code.id"/>
          <representation value="xmlAttr"/>
          <short value="Unique id for inter-element referencing"/>
          <definition
                      value="Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces."/>
          <min value="0"/>
          <max value="1"/>
          <base>
            <path value="Element.id"/>
            <min value="0"/>
            <max value="1"/>
          </base>
          <type>
            <extension
                       url="http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type">
              <valueUrl value="id"/>
            </extension>
            <code value="http://hl7.org/fhirpath/System.String"/>
          </type>
          <condition value="ele-1"/>
          <isModifier value="false"/>
          <isSummary value="false"/>
          <mapping>
            <identity value="rim"/>
            <map value="n/a"/>
          </mapping>
        </element>
        <element id="SubstanceDefinition.code:unii.code.extension">
          <path value="SubstanceDefinition.code.code.extension"/>
          <slicing>
            <discriminator>
              <type value="value"/>
              <path value="url"/>
            </discriminator>
            <description value="Extensions are always sliced by (at least) url"/>
            <rules value="open"/>
          </slicing>
          <short value="Additional content defined by implementations"/>
          <definition
                      value="May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension."/>
          <comment
                   value="There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions.  The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone."/>
          <alias value="extensions"/>
          <alias value="user content"/>
          <min value="0"/>
          <max value="*"/>
          <base>
            <path value="Element.extension"/>
            <min value="0"/>
            <max value="*"/>
          </base>
          <type>
            <code value="Extension"/>
          </type>
          <constraint>
            <key value="ele-1"/>
            <severity value="error"/>
            <human value="All FHIR elements must have a @value or children"/>
            <expression
                        value="hasValue() or (children().count() &gt; id.count())"/>
            <source value="http://hl7.org/fhir/StructureDefinition/Element"/>
          </constraint>
          <constraint>
            <key value="ext-1"/>
            <severity value="error"/>
            <human value="Must have either extensions or value[x], not both"/>
            <expression value="extension.exists() != value.exists()"/>
            <source value="http://hl7.org/fhir/StructureDefinition/Extension"/>
          </constraint>
          <isModifier value="false"/>
          <isSummary value="false"/>
          <mapping>
            <identity value="rim"/>
            <map value="n/a"/>
          </mapping>
        </element>
        <element id="SubstanceDefinition.code:unii.code.coding">
          <path value="SubstanceDefinition.code.code.coding"/>
          <short value="Code defined by a terminology system"/>
          <definition
                      value="A reference to a code defined by a terminology system."/>
          <comment
                   value="Codes may be defined very casually in enumerations, or code lists, up to very formal definitions such as SNOMED CT - see the HL7 v3 Core Principles for more information.  Ordering of codings is undefined and SHALL NOT be used to infer meaning. Generally, at most only one of the coding values will be labeled as UserSelected = true."/>
          <requirements
                        value="Allows for alternative encodings within a code system, and translations to other code systems."/>
          <min value="1"/>
          <max value="1"/>
          <base>
            <path value="CodeableConcept.coding"/>
            <min value="0"/>
            <max value="*"/>
          </base>
          <type>
            <code value="Coding"/>
          </type>
          <constraint>
            <key value="ele-1"/>
            <severity value="error"/>
            <human value="All FHIR elements must have a @value or children"/>
            <expression
                        value="hasValue() or (children().count() &gt; id.count())"/>
            <source value="http://hl7.org/fhir/StructureDefinition/Element"/>
          </constraint>
          <mustSupport value="true"/>
          <isModifier value="false"/>
          <isSummary value="true"/>
          <mapping>
            <identity value="v2"/>
            <map value="C*E.1-8, C*E.10-22"/>
          </mapping>
          <mapping>
            <identity value="rim"/>
            <map value="union(., ./translation)"/>
          </mapping>
          <mapping>
            <identity value="orim"/>
            <map
                 value="fhir:CodeableConcept.coding rdfs:subPropertyOf dt:CD.coding"/>
          </mapping>
        </element>
        <element id="SubstanceDefinition.code:unii.code.coding.id">
          <path value="SubstanceDefinition.code.code.coding.id"/>
          <representation value="xmlAttr"/>
          <short value="Unique id for inter-element referencing"/>
          <definition
                      value="Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces."/>
          <min value="0"/>
          <max value="1"/>
          <base>
            <path value="Element.id"/>
            <min value="0"/>
            <max value="1"/>
          </base>
          <type>
            <extension
                       url="http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type">
              <valueUrl value="id"/>
            </extension>
            <code value="http://hl7.org/fhirpath/System.String"/>
          </type>
          <condition value="ele-1"/>
          <isModifier value="false"/>
          <isSummary value="false"/>
          <mapping>
            <identity value="rim"/>
            <map value="n/a"/>
          </mapping>
        </element>
        <element id="SubstanceDefinition.code:unii.code.coding.extension">
          <path value="SubstanceDefinition.code.code.coding.extension"/>
          <slicing>
            <discriminator>
              <type value="value"/>
              <path value="url"/>
            </discriminator>
            <description value="Extensions are always sliced by (at least) url"/>
            <rules value="open"/>
          </slicing>
          <short value="Additional content defined by implementations"/>
          <definition
                      value="May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension."/>
          <comment
                   value="There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions.  The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone."/>
          <alias value="extensions"/>
          <alias value="user content"/>
          <min value="0"/>
          <max value="*"/>
          <base>
            <path value="Element.extension"/>
            <min value="0"/>
            <max value="*"/>
          </base>
          <type>
            <code value="Extension"/>
          </type>
          <constraint>
            <key value="ele-1"/>
            <severity value="error"/>
            <human value="All FHIR elements must have a @value or children"/>
            <expression
                        value="hasValue() or (children().count() &gt; id.count())"/>
            <source value="http://hl7.org/fhir/StructureDefinition/Element"/>
          </constraint>
          <constraint>
            <key value="ext-1"/>
            <severity value="error"/>
            <human value="Must have either extensions or value[x], not both"/>
            <expression value="extension.exists() != value.exists()"/>
            <source value="http://hl7.org/fhir/StructureDefinition/Extension"/>
          </constraint>
          <isModifier value="false"/>
          <isSummary value="false"/>
          <mapping>
            <identity value="rim"/>
            <map value="n/a"/>
          </mapping>
        </element>
        <element id="SubstanceDefinition.code:unii.code.coding.system">
          <path value="SubstanceDefinition.code.code.coding.system"/>
          <short value="Identity of the terminology system"/>
          <definition
                      value="The identification of the code system that defines the meaning of the symbol in the code."/>
          <comment
                   value="The URI may be an OID (urn:oid:...) or a UUID (urn:uuid:...).  OIDs and UUIDs SHALL be references to the HL7 OID registry. Otherwise, the URI should come from HL7's list of FHIR defined special URIs or it should be an absolute reference to some definition that establishes the system clearly and unambiguously."/>
          <requirements
                        value="Need to be unambiguous about the source of the definition of the symbol."/>
          <min value="1"/>
          <max value="1"/>
          <base>
            <path value="Coding.system"/>
            <min value="0"/>
            <max value="1"/>
          </base>
          <type>
            <code value="uri"/>
          </type>
          <patternUri value="http://fdasis.nlm.nih.gov"/>
          <constraint>
            <key value="ele-1"/>
            <severity value="error"/>
            <human value="All FHIR elements must have a @value or children"/>
            <expression
                        value="hasValue() or (children().count() &gt; id.count())"/>
            <source value="http://hl7.org/fhir/StructureDefinition/Element"/>
          </constraint>
          <mustSupport value="true"/>
          <isModifier value="false"/>
          <isSummary value="true"/>
          <mapping>
            <identity value="v2"/>
            <map value="C*E.3"/>
          </mapping>
          <mapping>
            <identity value="rim"/>
            <map value="./codeSystem"/>
          </mapping>
          <mapping>
            <identity value="orim"/>
            <map
                 value="fhir:Coding.system rdfs:subPropertyOf dt:CDCoding.codeSystem"/>
          </mapping>
        </element>
        <element id="SubstanceDefinition.code:unii.code.coding.version">
          <path value="SubstanceDefinition.code.code.coding.version"/>
          <short value="Version of the system - if relevant"/>
          <definition
                      value="The version of the code system which was used when choosing this code. Note that a well-maintained code system does not need the version reported, because the meaning of codes is consistent across versions. However this cannot consistently be assured, and when the meaning is not guaranteed to be consistent, the version SHOULD be exchanged."/>
          <comment
                   value="Where the terminology does not clearly define what string should be used to identify code system versions, the recommendation is to use the date (expressed in FHIR date format) on which that version was officially published as the version date."/>
          <min value="0"/>
          <max value="1"/>
          <base>
            <path value="Coding.version"/>
            <min value="0"/>
            <max value="1"/>
          </base>
          <type>
            <code value="string"/>
          </type>
          <constraint>
            <key value="ele-1"/>
            <severity value="error"/>
            <human value="All FHIR elements must have a @value or children"/>
            <expression
                        value="hasValue() or (children().count() &gt; id.count())"/>
            <source value="http://hl7.org/fhir/StructureDefinition/Element"/>
          </constraint>
          <isModifier value="false"/>
          <isSummary value="true"/>
          <mapping>
            <identity value="v2"/>
            <map value="C*E.7"/>
          </mapping>
          <mapping>
            <identity value="rim"/>
            <map value="./codeSystemVersion"/>
          </mapping>
          <mapping>
            <identity value="orim"/>
            <map
                 value="fhir:Coding.version rdfs:subPropertyOf dt:CDCoding.codeSystemVersion"/>
          </mapping>
        </element>
        <element id="SubstanceDefinition.code:unii.code.coding.code">
          <path value="SubstanceDefinition.code.code.coding.code"/>
          <short value="Symbol in syntax defined by the system"/>
          <definition
                      value="A symbol in syntax defined by the system. The symbol may be a predefined code or an expression in a syntax defined by the coding system (e.g. post-coordination)."/>
          <requirements
                        value="Need to refer to a particular code in the system."/>
          <min value="0"/>
          <max value="1"/>
          <base>
            <path value="Coding.code"/>
            <min value="0"/>
            <max value="1"/>
          </base>
          <type>
            <code value="code"/>
          </type>
          <condition value="cod-1"/>
          <constraint>
            <key value="ele-1"/>
            <severity value="error"/>
            <human value="All FHIR elements must have a @value or children"/>
            <expression
                        value="hasValue() or (children().count() &gt; id.count())"/>
            <source value="http://hl7.org/fhir/StructureDefinition/Element"/>
          </constraint>
          <isModifier value="false"/>
          <isSummary value="true"/>
          <mapping>
            <identity value="v2"/>
            <map value="C*E.1"/>
          </mapping>
          <mapping>
            <identity value="rim"/>
            <map value="./code"/>
          </mapping>
          <mapping>
            <identity value="orim"/>
            <map value="fhir:Coding.code rdfs:subPropertyOf dt:CDCoding.code"/>
          </mapping>
        </element>
        <element id="SubstanceDefinition.code:unii.code.coding.display">
          <extension
                     url="http://hl7.org/fhir/StructureDefinition/elementdefinition-translatable">
            <valueBoolean value="true"/>
          </extension>
          <extension
                     url="http://hl7.org/fhir/StructureDefinition/elementdefinition-translatable">
            <valueBoolean value="true"/>
          </extension>
          <path value="SubstanceDefinition.code.code.coding.display"/>
          <short value="Representation defined by the system"/>
          <definition
                      value="A representation of the meaning of the code in the system, following the rules of the system."/>
          <requirements
                        value="Need to be able to carry a human-readable meaning of the code for readers that do not know  the system."/>
          <min value="0"/>
          <max value="1"/>
          <base>
            <path value="Coding.display"/>
            <min value="0"/>
            <max value="1"/>
          </base>
          <type>
            <code value="string"/>
          </type>
          <condition value="cod-1"/>
          <constraint>
            <key value="ele-1"/>
            <severity value="error"/>
            <human value="All FHIR elements must have a @value or children"/>
            <expression
                        value="hasValue() or (children().count() &gt; id.count())"/>
            <source value="http://hl7.org/fhir/StructureDefinition/Element"/>
          </constraint>
          <isModifier value="false"/>
          <isSummary value="true"/>
          <mapping>
            <identity value="v2"/>
            <map value="C*E.2 - but note this is not well followed"/>
          </mapping>
          <mapping>
            <identity value="rim"/>
            <map value="CV.displayName"/>
          </mapping>
          <mapping>
            <identity value="orim"/>
            <map
                 value="fhir:Coding.display rdfs:subPropertyOf dt:CDCoding.displayName"/>
          </mapping>
        </element>
        <element id="SubstanceDefinition.code:unii.code.coding.userSelected">
          <path value="SubstanceDefinition.code.code.coding.userSelected"/>
          <short value="If this coding was chosen directly by the user"/>
          <definition
                      value="Indicates that this coding was chosen by a user directly - e.g. off a pick list of available items (codes or displays)."/>
          <comment
                   value="Amongst a set of alternatives, a directly chosen code is the most appropriate starting point for new translations. There is some ambiguity about what exactly 'directly chosen' implies, and trading partner agreement may be needed to clarify the use of this element and its consequences more completely."/>
          <requirements
                        value="This has been identified as a clinical safety criterium - that this exact system/code pair was chosen explicitly, rather than inferred by the system based on some rules or language processing."/>
          <min value="0"/>
          <max value="1"/>
          <base>
            <path value="Coding.userSelected"/>
            <min value="0"/>
            <max value="1"/>
          </base>
          <type>
            <code value="boolean"/>
          </type>
          <constraint>
            <key value="ele-1"/>
            <severity value="error"/>
            <human value="All FHIR elements must have a @value or children"/>
            <expression
                        value="hasValue() or (children().count() &gt; id.count())"/>
            <source value="http://hl7.org/fhir/StructureDefinition/Element"/>
          </constraint>
          <isModifier value="false"/>
          <isSummary value="true"/>
          <mapping>
            <identity value="v2"/>
            <map value="Sometimes implied by being first"/>
          </mapping>
          <mapping>
            <identity value="rim"/>
            <map value="CD.codingRationale"/>
          </mapping>
          <mapping>
            <identity value="orim"/>
            <map
                 value="fhir:Coding.userSelected fhir:mapsTo dt:CDCoding.codingRationale. fhir:Coding.userSelected fhir:hasMap fhir:Coding.userSelected.map. fhir:Coding.userSelected.map a fhir:Map;   fhir:target dt:CDCoding.codingRationale. fhir:Coding.userSelected\#true a [     fhir:source &quot;true&quot;;     fhir:target dt:CDCoding.codingRationale\#O   ]"/>
          </mapping>
        </element>
        <element id="SubstanceDefinition.code:unii.code.text">
          <extension
                     url="http://hl7.org/fhir/StructureDefinition/elementdefinition-translatable">
            <valueBoolean value="true"/>
          </extension>
          <extension
                     url="http://hl7.org/fhir/StructureDefinition/elementdefinition-translatable">
            <valueBoolean value="true"/>
          </extension>
          <path value="SubstanceDefinition.code.code.text"/>
          <short value="Plain text representation of the concept"/>
          <definition
                      value="A human language representation of the concept as seen/selected/uttered by the user who entered the data and/or which represents the intended meaning of the user."/>
          <comment
                   value="Very often the text is the same as a displayName of one of the codings."/>
          <requirements
                        value="The codes from the terminologies do not always capture the correct meaning with all the nuances of the human using them, or sometimes there is no appropriate code at all. In these cases, the text is used to capture the full meaning of the source."/>
          <min value="0"/>
          <max value="1"/>
          <base>
            <path value="CodeableConcept.text"/>
            <min value="0"/>
            <max value="1"/>
          </base>
          <type>
            <code value="string"/>
          </type>
          <constraint>
            <key value="ele-1"/>
            <severity value="error"/>
            <human value="All FHIR elements must have a @value or children"/>
            <expression
                        value="hasValue() or (children().count() &gt; id.count())"/>
            <source value="http://hl7.org/fhir/StructureDefinition/Element"/>
          </constraint>
          <isModifier value="false"/>
          <isSummary value="true"/>
          <mapping>
            <identity value="v2"/>
            <map value="C*E.9. But note many systems use C*E.2 for this"/>
          </mapping>
          <mapping>
            <identity value="rim"/>
            <map
                 value="./originalText[mediaType/code=&quot;text/plain&quot;]/data"/>
          </mapping>
          <mapping>
            <identity value="orim"/>
            <map
                 value="fhir:CodeableConcept.text rdfs:subPropertyOf dt:CD.originalText"/>
          </mapping>
        </element>
        <element id="SubstanceDefinition.code:unii.status">
          <path value="SubstanceDefinition.code.status"/>
          <short
                 value="Status of the code assignment, for example 'provisional', 'approved'"/>
          <definition
                      value="Status of the code assignment, for example 'provisional', 'approved'."/>
          <min value="0"/>
          <max value="1"/>
          <base>
            <path value="SubstanceDefinition.code.status"/>
            <min value="0"/>
            <max value="1"/>
          </base>
          <type>
            <code value="CodeableConcept"/>
          </type>
          <constraint>
            <key value="ele-1"/>
            <severity value="error"/>
            <human value="All FHIR elements must have a @value or children"/>
            <expression
                        value="hasValue() or (children().count() &gt; id.count())"/>
            <source value="http://hl7.org/fhir/StructureDefinition/Element"/>
          </constraint>
          <mustSupport value="false"/>
          <isModifier value="false"/>
          <isSummary value="true"/>
          <binding>
            <extension
                       url="http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName">
              <valueString value="PublicationStatus"/>
            </extension>
            <strength value="preferred"/>
            <description value="The lifecycle status of an artifact."/>
            <valueSet value="http://hl7.org/fhir/ValueSet/publication-status"/>
          </binding>
          <mapping>
            <identity value="idmp-substance"/>
            <map value="Substance_Code.Code_System_Status"/>
          </mapping>
        </element>
        <element id="SubstanceDefinition.code:unii.statusDate">
          <path value="SubstanceDefinition.code.statusDate"/>
          <short value="The date at which the code status was changed"/>
          <definition
                      value="The date at which the code status was changed as part of the terminology maintenance."/>
          <min value="0"/>
          <max value="1"/>
          <base>
            <path value="SubstanceDefinition.code.statusDate"/>
            <min value="0"/>
            <max value="1"/>
          </base>
          <type>
            <code value="dateTime"/>
          </type>
          <constraint>
            <key value="ele-1"/>
            <severity value="error"/>
            <human value="All FHIR elements must have a @value or children"/>
            <expression
                        value="hasValue() or (children().count() &gt; id.count())"/>
            <source value="http://hl7.org/fhir/StructureDefinition/Element"/>
          </constraint>
          <mustSupport value="false"/>
          <isModifier value="false"/>
          <isSummary value="true"/>
          <mapping>
            <identity value="idmp-substance"/>
            <map value="Substance_Code.Code_Change_Date"/>
          </mapping>
        </element>
        <element id="SubstanceDefinition.code:unii.note">
          <path value="SubstanceDefinition.code.note"/>
          <short value="Any comment can be provided in this field"/>
          <definition
                      value="Any comment can be provided in this field, if necessary."/>
          <min value="0"/>
          <max value="*"/>
          <base>
            <path value="SubstanceDefinition.code.note"/>
            <min value="0"/>
            <max value="*"/>
          </base>
          <type>
            <code value="Annotation"/>
          </type>
          <constraint>
            <key value="ele-1"/>
            <severity value="error"/>
            <human value="All FHIR elements must have a @value or children"/>
            <expression
                        value="hasValue() or (children().count() &gt; id.count())"/>
            <source value="http://hl7.org/fhir/StructureDefinition/Element"/>
          </constraint>
          <mustSupport value="false"/>
          <isModifier value="false"/>
          <isSummary value="true"/>
          <mapping>
            <identity value="idmp-substance"/>
            <map value="Substance_Code.Comment"/>
          </mapping>
        </element>
        <element id="SubstanceDefinition.code:unii.source">
          <path value="SubstanceDefinition.code.source"/>
          <short value="Supporting literature"/>
          <definition value="Supporting literature."/>
          <min value="0"/>
          <max value="*"/>
          <base>
            <path value="SubstanceDefinition.code.source"/>
            <min value="0"/>
            <max value="*"/>
          </base>
          <type>
            <code value="Reference"/>
            <targetProfile
                           value="http://hl7.org/fhir/StructureDefinition/DocumentReference"/>
          </type>
          <constraint>
            <key value="ele-1"/>
            <severity value="error"/>
            <human value="All FHIR elements must have a @value or children"/>
            <expression
                        value="hasValue() or (children().count() &gt; id.count())"/>
            <source value="http://hl7.org/fhir/StructureDefinition/Element"/>
          </constraint>
          <mustSupport value="false"/>
          <isModifier value="false"/>
          <isSummary value="true"/>
          <mapping>
            <identity value="idmp-substance"/>
            <map value="Substance_Code.Reference_Source"/>
          </mapping>
        </element>
        <element id="SubstanceDefinition.code:uniProt">
          <path value="SubstanceDefinition.code"/>
          <sliceName value="uniProt"/>
          <short value="UniProt ID"/>
          <definition
                      value="The  UniProt ID is an index to the UniProt knowledgebase,  a large resource of protein sequences and associated detailed annotation.
    It is accessible at https://www.uniprot.org/"/>
          <min value="0"/>
          <max value="1"/>
          <base>
            <path value="SubstanceDefinition.code"/>
            <min value="0"/>
            <max value="*"/>
          </base>
          <type>
            <code value="BackboneElement"/>
          </type>
          <constraint>
            <key value="ele-1"/>
            <severity value="error"/>
            <human value="All FHIR elements must have a @value or children"/>
            <expression
                        value="hasValue() or (children().count() &gt; id.count())"/>
            <source value="http://hl7.org/fhir/StructureDefinition/Element"/>
          </constraint>
          <mustSupport value="true"/>
          <isModifier value="false"/>
          <isSummary value="true"/>
          <mapping>
            <identity value="idmp-substance"/>
            <map value="Substance.Substance_Code"/>
          </mapping>
        </element>
        <element id="SubstanceDefinition.code:uniProt.id">
          <path value="SubstanceDefinition.code.id"/>
          <representation value="xmlAttr"/>
          <short value="Unique id for inter-element referencing"/>
          <definition
                      value="Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces."/>
          <min value="0"/>
          <max value="1"/>
          <base>
            <path value="Element.id"/>
            <min value="0"/>
            <max value="1"/>
          </base>
          <type>
            <extension
                       url="http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type">
              <valueUrl value="string"/>
            </extension>
            <code value="http://hl7.org/fhirpath/System.String"/>
          </type>
          <condition value="ele-1"/>
          <isModifier value="false"/>
          <isSummary value="false"/>
          <mapping>
            <identity value="rim"/>
            <map value="n/a"/>
          </mapping>
        </element>
        <element id="SubstanceDefinition.code:uniProt.extension">
          <path value="SubstanceDefinition.code.extension"/>
          <short value="Additional content defined by implementations"/>
          <definition
                      value="May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension."/>
          <comment
                   value="There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions.  The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone."/>
          <alias value="extensions"/>
          <alias value="user content"/>
          <min value="0"/>
          <max value="*"/>
          <base>
            <path value="Element.extension"/>
            <min value="0"/>
            <max value="*"/>
          </base>
          <type>
            <code value="Extension"/>
          </type>
          <constraint>
            <key value="ele-1"/>
            <severity value="error"/>
            <human value="All FHIR elements must have a @value or children"/>
            <expression
                        value="hasValue() or (children().count() &gt; id.count())"/>
            <source value="http://hl7.org/fhir/StructureDefinition/Element"/>
          </constraint>
          <constraint>
            <key value="ext-1"/>
            <severity value="error"/>
            <human value="Must have either extensions or value[x], not both"/>
            <expression value="extension.exists() != value.exists()"/>
            <source value="http://hl7.org/fhir/StructureDefinition/Extension"/>
          </constraint>
          <isModifier value="false"/>
          <isSummary value="false"/>
          <mapping>
            <identity value="rim"/>
            <map value="n/a"/>
          </mapping>
        </element>
        <element id="SubstanceDefinition.code:uniProt.modifierExtension">
          <path value="SubstanceDefinition.code.modifierExtension"/>
          <short value="Extensions that cannot be ignored even if unrecognized"/>
          <definition
                      value="May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.

    Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself)."/>
          <comment
                   value="There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions.  The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone."/>
          <requirements
                        value="Modifier extensions allow for extensions that *cannot* be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored.  This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the [definition of modifier extensions](http://hl7.org/fhir/R5/extensibility.html#modifierExtension)."/>
          <alias value="extensions"/>
          <alias value="user content"/>
          <alias value="modifiers"/>
          <min value="0"/>
          <max value="*"/>
          <base>
            <path value="BackboneElement.modifierExtension"/>
            <min value="0"/>
            <max value="*"/>
          </base>
          <type>
            <code value="Extension"/>
          </type>
          <constraint>
            <key value="ele-1"/>
            <severity value="error"/>
            <human value="All FHIR elements must have a @value or children"/>
            <expression
                        value="hasValue() or (children().count() &gt; id.count())"/>
            <source value="http://hl7.org/fhir/StructureDefinition/Element"/>
          </constraint>
          <constraint>
            <key value="ext-1"/>
            <severity value="error"/>
            <human value="Must have either extensions or value[x], not both"/>
            <expression value="extension.exists() != value.exists()"/>
            <source value="http://hl7.org/fhir/StructureDefinition/Extension"/>
          </constraint>
          <isModifier value="true"/>
          <isModifierReason
                            value="Modifier extensions are expected to modify the meaning or interpretation of the element that contains them"/>
          <isSummary value="true"/>
          <mapping>
            <identity value="rim"/>
            <map value="N/A"/>
          </mapping>
        </element>
        <element id="SubstanceDefinition.code:uniProt.code">
          <path value="SubstanceDefinition.code.code"/>
          <short value="The specific code"/>
          <definition value="The specific code."/>
          <min value="1"/>
          <max value="1"/>
          <base>
            <path value="SubstanceDefinition.code.code"/>
            <min value="0"/>
            <max value="1"/>
          </base>
          <type>
            <code value="CodeableConcept"/>
          </type>
          <constraint>
            <key value="ele-1"/>
            <severity value="error"/>
            <human value="All FHIR elements must have a @value or children"/>
            <expression
                        value="hasValue() or (children().count() &gt; id.count())"/>
            <source value="http://hl7.org/fhir/StructureDefinition/Element"/>
          </constraint>
          <mustSupport value="true"/>
          <isModifier value="false"/>
          <isSummary value="true"/>
          <mapping>
            <identity value="idmp-substance"/>
            <map
                 value="Substance_Code.Code, Substance_Code.Code_System, Substance_Code.Code_System_Id"/>
          </mapping>
        </element>
        <element id="SubstanceDefinition.code:uniProt.code.id">
          <path value="SubstanceDefinition.code.code.id"/>
          <representation value="xmlAttr"/>
          <short value="Unique id for inter-element referencing"/>
          <definition
                      value="Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces."/>
          <min value="0"/>
          <max value="1"/>
          <base>
            <path value="Element.id"/>
            <min value="0"/>
            <max value="1"/>
          </base>
          <type>
            <extension
                       url="http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type">
              <valueUrl value="id"/>
            </extension>
            <code value="http://hl7.org/fhirpath/System.String"/>
          </type>
          <condition value="ele-1"/>
          <isModifier value="false"/>
          <isSummary value="false"/>
          <mapping>
            <identity value="rim"/>
            <map value="n/a"/>
          </mapping>
        </element>
        <element id="SubstanceDefinition.code:uniProt.code.extension">
          <path value="SubstanceDefinition.code.code.extension"/>
          <slicing>
            <discriminator>
              <type value="value"/>
              <path value="url"/>
            </discriminator>
            <description value="Extensions are always sliced by (at least) url"/>
            <rules value="open"/>
          </slicing>
          <short value="Additional content defined by implementations"/>
          <definition
                      value="May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension."/>
          <comment
                   value="There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions.  The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone."/>
          <alias value="extensions"/>
          <alias value="user content"/>
          <min value="0"/>
          <max value="*"/>
          <base>
            <path value="Element.extension"/>
            <min value="0"/>
            <max value="*"/>
          </base>
          <type>
            <code value="Extension"/>
          </type>
          <constraint>
            <key value="ele-1"/>
            <severity value="error"/>
            <human value="All FHIR elements must have a @value or children"/>
            <expression
                        value="hasValue() or (children().count() &gt; id.count())"/>
            <source value="http://hl7.org/fhir/StructureDefinition/Element"/>
          </constraint>
          <constraint>
            <key value="ext-1"/>
            <severity value="error"/>
            <human value="Must have either extensions or value[x], not both"/>
            <expression value="extension.exists() != value.exists()"/>
            <source value="http://hl7.org/fhir/StructureDefinition/Extension"/>
          </constraint>
          <isModifier value="false"/>
          <isSummary value="false"/>
          <mapping>
            <identity value="rim"/>
            <map value="n/a"/>
          </mapping>
        </element>
        <element id="SubstanceDefinition.code:uniProt.code.coding">
          <path value="SubstanceDefinition.code.code.coding"/>
          <short value="Code defined by a terminology system"/>
          <definition
                      value="A reference to a code defined by a terminology system."/>
          <comment
                   value="Codes may be defined very casually in enumerations, or code lists, up to very formal definitions such as SNOMED CT - see the HL7 v3 Core Principles for more information.  Ordering of codings is undefined and SHALL NOT be used to infer meaning. Generally, at most only one of the coding values will be labeled as UserSelected = true."/>
          <requirements
                        value="Allows for alternative encodings within a code system, and translations to other code systems."/>
          <min value="1"/>
          <max value="1"/>
          <base>
            <path value="CodeableConcept.coding"/>
            <min value="0"/>
            <max value="*"/>
          </base>
          <type>
            <code value="Coding"/>
          </type>
          <constraint>
            <key value="ele-1"/>
            <severity value="error"/>
            <human value="All FHIR elements must have a @value or children"/>
            <expression
                        value="hasValue() or (children().count() &gt; id.count())"/>
            <source value="http://hl7.org/fhir/StructureDefinition/Element"/>
          </constraint>
          <mustSupport value="true"/>
          <isModifier value="false"/>
          <isSummary value="true"/>
          <mapping>
            <identity value="v2"/>
            <map value="C*E.1-8, C*E.10-22"/>
          </mapping>
          <mapping>
            <identity value="rim"/>
            <map value="union(., ./translation)"/>
          </mapping>
          <mapping>
            <identity value="orim"/>
            <map
                 value="fhir:CodeableConcept.coding rdfs:subPropertyOf dt:CD.coding"/>
          </mapping>
        </element>
        <element id="SubstanceDefinition.code:uniProt.code.coding.id">
          <path value="SubstanceDefinition.code.code.coding.id"/>
          <representation value="xmlAttr"/>
          <short value="Unique id for inter-element referencing"/>
          <definition
                      value="Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces."/>
          <min value="0"/>
          <max value="1"/>
          <base>
            <path value="Element.id"/>
            <min value="0"/>
            <max value="1"/>
          </base>
          <type>
            <extension
                       url="http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type">
              <valueUrl value="id"/>
            </extension>
            <code value="http://hl7.org/fhirpath/System.String"/>
          </type>
          <condition value="ele-1"/>
          <isModifier value="false"/>
          <isSummary value="false"/>
          <mapping>
            <identity value="rim"/>
            <map value="n/a"/>
          </mapping>
        </element>
        <element id="SubstanceDefinition.code:uniProt.code.coding.extension">
          <path value="SubstanceDefinition.code.code.coding.extension"/>
          <slicing>
            <discriminator>
              <type value="value"/>
              <path value="url"/>
            </discriminator>
            <description value="Extensions are always sliced by (at least) url"/>
            <rules value="open"/>
          </slicing>
          <short value="Additional content defined by implementations"/>
          <definition
                      value="May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension."/>
          <comment
                   value="There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions.  The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone."/>
          <alias value="extensions"/>
          <alias value="user content"/>
          <min value="0"/>
          <max value="*"/>
          <base>
            <path value="Element.extension"/>
            <min value="0"/>
            <max value="*"/>
          </base>
          <type>
            <code value="Extension"/>
          </type>
          <constraint>
            <key value="ele-1"/>
            <severity value="error"/>
            <human value="All FHIR elements must have a @value or children"/>
            <expression
                        value="hasValue() or (children().count() &gt; id.count())"/>
            <source value="http://hl7.org/fhir/StructureDefinition/Element"/>
          </constraint>
          <constraint>
            <key value="ext-1"/>
            <severity value="error"/>
            <human value="Must have either extensions or value[x], not both"/>
            <expression value="extension.exists() != value.exists()"/>
            <source value="http://hl7.org/fhir/StructureDefinition/Extension"/>
          </constraint>
          <isModifier value="false"/>
          <isSummary value="false"/>
          <mapping>
            <identity value="rim"/>
            <map value="n/a"/>
          </mapping>
        </element>
        <element id="SubstanceDefinition.code:uniProt.code.coding.system">
          <path value="SubstanceDefinition.code.code.coding.system"/>
          <short value="Identity of the terminology system"/>
          <definition
                      value="The identification of the code system that defines the meaning of the symbol in the code."/>
          <comment
                   value="The URI may be an OID (urn:oid:...) or a UUID (urn:uuid:...).  OIDs and UUIDs SHALL be references to the HL7 OID registry. Otherwise, the URI should come from HL7's list of FHIR defined special URIs or it should be an absolute reference to some definition that establishes the system clearly and unambiguously."/>
          <requirements
                        value="Need to be unambiguous about the source of the definition of the symbol."/>
          <min value="1"/>
          <max value="1"/>
          <base>
            <path value="Coding.system"/>
            <min value="0"/>
            <max value="1"/>
          </base>
          <type>
            <code value="uri"/>
          </type>
          <patternUri value="http://terminology.hl7.org/NamingSystem/UniProt"/>
          <constraint>
            <key value="ele-1"/>
            <severity value="error"/>
            <human value="All FHIR elements must have a @value or children"/>
            <expression
                        value="hasValue() or (children().count() &gt; id.count())"/>
            <source value="http://hl7.org/fhir/StructureDefinition/Element"/>
          </constraint>
          <mustSupport value="true"/>
          <isModifier value="false"/>
          <isSummary value="true"/>
          <mapping>
            <identity value="v2"/>
            <map value="C*E.3"/>
          </mapping>
          <mapping>
            <identity value="rim"/>
            <map value="./codeSystem"/>
          </mapping>
          <mapping>
            <identity value="orim"/>
            <map
                 value="fhir:Coding.system rdfs:subPropertyOf dt:CDCoding.codeSystem"/>
          </mapping>
        </element>
        <element id="SubstanceDefinition.code:uniProt.code.coding.version">
          <path value="SubstanceDefinition.code.code.coding.version"/>
          <short value="Version of the system - if relevant"/>
          <definition
                      value="The version of the code system which was used when choosing this code. Note that a well-maintained code system does not need the version reported, because the meaning of codes is consistent across versions. However this cannot consistently be assured, and when the meaning is not guaranteed to be consistent, the version SHOULD be exchanged."/>
          <comment
                   value="Where the terminology does not clearly define what string should be used to identify code system versions, the recommendation is to use the date (expressed in FHIR date format) on which that version was officially published as the version date."/>
          <min value="0"/>
          <max value="1"/>
          <base>
            <path value="Coding.version"/>
            <min value="0"/>
            <max value="1"/>
          </base>
          <type>
            <code value="string"/>
          </type>
          <constraint>
            <key value="ele-1"/>
            <severity value="error"/>
            <human value="All FHIR elements must have a @value or children"/>
            <expression
                        value="hasValue() or (children().count() &gt; id.count())"/>
            <source value="http://hl7.org/fhir/StructureDefinition/Element"/>
          </constraint>
          <isModifier value="false"/>
          <isSummary value="true"/>
          <mapping>
            <identity value="v2"/>
            <map value="C*E.7"/>
          </mapping>
          <mapping>
            <identity value="rim"/>
            <map value="./codeSystemVersion"/>
          </mapping>
          <mapping>
            <identity value="orim"/>
            <map
                 value="fhir:Coding.version rdfs:subPropertyOf dt:CDCoding.codeSystemVersion"/>
          </mapping>
        </element>
        <element id="SubstanceDefinition.code:uniProt.code.coding.code">
          <path value="SubstanceDefinition.code.code.coding.code"/>
          <short value="Symbol in syntax defined by the system"/>
          <definition
                      value="A symbol in syntax defined by the system. The symbol may be a predefined code or an expression in a syntax defined by the coding system (e.g. post-coordination)."/>
          <requirements
                        value="Need to refer to a particular code in the system."/>
          <min value="0"/>
          <max value="1"/>
          <base>
            <path value="Coding.code"/>
            <min value="0"/>
            <max value="1"/>
          </base>
          <type>
            <code value="code"/>
          </type>
          <condition value="cod-1"/>
          <constraint>
            <key value="ele-1"/>
            <severity value="error"/>
            <human value="All FHIR elements must have a @value or children"/>
            <expression
                        value="hasValue() or (children().count() &gt; id.count())"/>
            <source value="http://hl7.org/fhir/StructureDefinition/Element"/>
          </constraint>
          <isModifier value="false"/>
          <isSummary value="true"/>
          <mapping>
            <identity value="v2"/>
            <map value="C*E.1"/>
          </mapping>
          <mapping>
            <identity value="rim"/>
            <map value="./code"/>
          </mapping>
          <mapping>
            <identity value="orim"/>
            <map value="fhir:Coding.code rdfs:subPropertyOf dt:CDCoding.code"/>
          </mapping>
        </element>
        <element id="SubstanceDefinition.code:uniProt.code.coding.display">
          <extension
                     url="http://hl7.org/fhir/StructureDefinition/elementdefinition-translatable">
            <valueBoolean value="true"/>
          </extension>
          <extension
                     url="http://hl7.org/fhir/StructureDefinition/elementdefinition-translatable">
            <valueBoolean value="true"/>
          </extension>
          <path value="SubstanceDefinition.code.code.coding.display"/>
          <short value="Representation defined by the system"/>
          <definition
                      value="A representation of the meaning of the code in the system, following the rules of the system."/>
          <requirements
                        value="Need to be able to carry a human-readable meaning of the code for readers that do not know  the system."/>
          <min value="0"/>
          <max value="1"/>
          <base>
            <path value="Coding.display"/>
            <min value="0"/>
            <max value="1"/>
          </base>
          <type>
            <code value="string"/>
          </type>
          <condition value="cod-1"/>
          <constraint>
            <key value="ele-1"/>
            <severity value="error"/>
            <human value="All FHIR elements must have a @value or children"/>
            <expression
                        value="hasValue() or (children().count() &gt; id.count())"/>
            <source value="http://hl7.org/fhir/StructureDefinition/Element"/>
          </constraint>
          <isModifier value="false"/>
          <isSummary value="true"/>
          <mapping>
            <identity value="v2"/>
            <map value="C*E.2 - but note this is not well followed"/>
          </mapping>
          <mapping>
            <identity value="rim"/>
            <map value="CV.displayName"/>
          </mapping>
          <mapping>
            <identity value="orim"/>
            <map
                 value="fhir:Coding.display rdfs:subPropertyOf dt:CDCoding.displayName"/>
          </mapping>
        </element>
        <element id="SubstanceDefinition.code:uniProt.code.coding.userSelected">
          <path value="SubstanceDefinition.code.code.coding.userSelected"/>
          <short value="If this coding was chosen directly by the user"/>
          <definition
                      value="Indicates that this coding was chosen by a user directly - e.g. off a pick list of available items (codes or displays)."/>
          <comment
                   value="Amongst a set of alternatives, a directly chosen code is the most appropriate starting point for new translations. There is some ambiguity about what exactly 'directly chosen' implies, and trading partner agreement may be needed to clarify the use of this element and its consequences more completely."/>
          <requirements
                        value="This has been identified as a clinical safety criterium - that this exact system/code pair was chosen explicitly, rather than inferred by the system based on some rules or language processing."/>
          <min value="0"/>
          <max value="1"/>
          <base>
            <path value="Coding.userSelected"/>
            <min value="0"/>
            <max value="1"/>
          </base>
          <type>
            <code value="boolean"/>
          </type>
          <constraint>
            <key value="ele-1"/>
            <severity value="error"/>
            <human value="All FHIR elements must have a @value or children"/>
            <expression
                        value="hasValue() or (children().count() &gt; id.count())"/>
            <source value="http://hl7.org/fhir/StructureDefinition/Element"/>
          </constraint>
          <isModifier value="false"/>
          <isSummary value="true"/>
          <mapping>
            <identity value="v2"/>
            <map value="Sometimes implied by being first"/>
          </mapping>
          <mapping>
            <identity value="rim"/>
            <map value="CD.codingRationale"/>
          </mapping>
          <mapping>
            <identity value="orim"/>
            <map
                 value="fhir:Coding.userSelected fhir:mapsTo dt:CDCoding.codingRationale. fhir:Coding.userSelected fhir:hasMap fhir:Coding.userSelected.map. fhir:Coding.userSelected.map a fhir:Map;   fhir:target dt:CDCoding.codingRationale. fhir:Coding.userSelected\#true a [     fhir:source &quot;true&quot;;     fhir:target dt:CDCoding.codingRationale\#O   ]"/>
          </mapping>
        </element>
        <element id="SubstanceDefinition.code:uniProt.code.text">
          <extension
                     url="http://hl7.org/fhir/StructureDefinition/elementdefinition-translatable">
            <valueBoolean value="true"/>
          </extension>
          <extension
                     url="http://hl7.org/fhir/StructureDefinition/elementdefinition-translatable">
            <valueBoolean value="true"/>
          </extension>
          <path value="SubstanceDefinition.code.code.text"/>
          <short value="Plain text representation of the concept"/>
          <definition
                      value="A human language representation of the concept as seen/selected/uttered by the user who entered the data and/or which represents the intended meaning of the user."/>
          <comment
                   value="Very often the text is the same as a displayName of one of the codings."/>
          <requirements
                        value="The codes from the terminologies do not always capture the correct meaning with all the nuances of the human using them, or sometimes there is no appropriate code at all. In these cases, the text is used to capture the full meaning of the source."/>
          <min value="0"/>
          <max value="1"/>
          <base>
            <path value="CodeableConcept.text"/>
            <min value="0"/>
            <max value="1"/>
          </base>
          <type>
            <code value="string"/>
          </type>
          <constraint>
            <key value="ele-1"/>
            <severity value="error"/>
            <human value="All FHIR elements must have a @value or children"/>
            <expression
                        value="hasValue() or (children().count() &gt; id.count())"/>
            <source value="http://hl7.org/fhir/StructureDefinition/Element"/>
          </constraint>
          <isModifier value="false"/>
          <isSummary value="true"/>
          <mapping>
            <identity value="v2"/>
            <map value="C*E.9. But note many systems use C*E.2 for this"/>
          </mapping>
          <mapping>
            <identity value="rim"/>
            <map
                 value="./originalText[mediaType/code=&quot;text/plain&quot;]/data"/>
          </mapping>
          <mapping>
            <identity value="orim"/>
            <map
                 value="fhir:CodeableConcept.text rdfs:subPropertyOf dt:CD.originalText"/>
          </mapping>
        </element>
        <element id="SubstanceDefinition.code:uniProt.status">
          <path value="SubstanceDefinition.code.status"/>
          <short
                 value="Status of the code assignment, for example 'provisional', 'approved'"/>
          <definition
                      value="Status of the code assignment, for example 'provisional', 'approved'."/>
          <min value="0"/>
          <max value="1"/>
          <base>
            <path value="SubstanceDefinition.code.status"/>
            <min value="0"/>
            <max value="1"/>
          </base>
          <type>
            <code value="CodeableConcept"/>
          </type>
          <constraint>
            <key value="ele-1"/>
            <severity value="error"/>
            <human value="All FHIR elements must have a @value or children"/>
            <expression
                        value="hasValue() or (children().count() &gt; id.count())"/>
            <source value="http://hl7.org/fhir/StructureDefinition/Element"/>
          </constraint>
          <mustSupport value="false"/>
          <isModifier value="false"/>
          <isSummary value="true"/>
          <binding>
            <extension
                       url="http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName">
              <valueString value="PublicationStatus"/>
            </extension>
            <strength value="preferred"/>
            <description value="The lifecycle status of an artifact."/>
            <valueSet value="http://hl7.org/fhir/ValueSet/publication-status"/>
          </binding>
          <mapping>
            <identity value="idmp-substance"/>
            <map value="Substance_Code.Code_System_Status"/>
          </mapping>
        </element>
        <element id="SubstanceDefinition.code:uniProt.statusDate">
          <path value="SubstanceDefinition.code.statusDate"/>
          <short value="The date at which the code status was changed"/>
          <definition
                      value="The date at which the code status was changed as part of the terminology maintenance."/>
          <min value="0"/>
          <max value="1"/>
          <base>
            <path value="SubstanceDefinition.code.statusDate"/>
            <min value="0"/>
            <max value="1"/>
          </base>
          <type>
            <code value="dateTime"/>
          </type>
          <constraint>
            <key value="ele-1"/>
            <severity value="error"/>
            <human value="All FHIR elements must have a @value or children"/>
            <expression
                        value="hasValue() or (children().count() &gt; id.count())"/>
            <source value="http://hl7.org/fhir/StructureDefinition/Element"/>
          </constraint>
          <mustSupport value="false"/>
          <isModifier value="false"/>
          <isSummary value="true"/>
          <mapping>
            <identity value="idmp-substance"/>
            <map value="Substance_Code.Code_Change_Date"/>
          </mapping>
        </element>
        <element id="SubstanceDefinition.code:uniProt.note">
          <path value="SubstanceDefinition.code.note"/>
          <short value="Any comment can be provided in this field"/>
          <definition
                      value="Any comment can be provided in this field, if necessary."/>
          <min value="0"/>
          <max value="*"/>
          <base>
            <path value="SubstanceDefinition.code.note"/>
            <min value="0"/>
            <max value="*"/>
          </base>
          <type>
            <code value="Annotation"/>
          </type>
          <constraint>
            <key value="ele-1"/>
            <severity value="error"/>
            <human value="All FHIR elements must have a @value or children"/>
            <expression
                        value="hasValue() or (children().count() &gt; id.count())"/>
            <source value="http://hl7.org/fhir/StructureDefinition/Element"/>
          </constraint>
          <mustSupport value="false"/>
          <isModifier value="false"/>
          <isSummary value="true"/>
          <mapping>
            <identity value="idmp-substance"/>
            <map value="Substance_Code.Comment"/>
          </mapping>
        </element>
        <element id="SubstanceDefinition.code:uniProt.source">
          <path value="SubstanceDefinition.code.source"/>
          <short value="Supporting literature"/>
          <definition value="Supporting literature."/>
          <min value="0"/>
          <max value="*"/>
          <base>
            <path value="SubstanceDefinition.code.source"/>
            <min value="0"/>
            <max value="*"/>
          </base>
          <type>
            <code value="Reference"/>
            <targetProfile
                           value="http://hl7.org/fhir/StructureDefinition/DocumentReference"/>
          </type>
          <constraint>
            <key value="ele-1"/>
            <severity value="error"/>
            <human value="All FHIR elements must have a @value or children"/>
            <expression
                        value="hasValue() or (children().count() &gt; id.count())"/>
            <source value="http://hl7.org/fhir/StructureDefinition/Element"/>
          </constraint>
          <mustSupport value="false"/>
          <isModifier value="false"/>
          <isSummary value="true"/>
          <mapping>
            <identity value="idmp-substance"/>
            <map value="Substance_Code.Reference_Source"/>
          </mapping>
        </element>
        <element id="SubstanceDefinition.name">
          <path value="SubstanceDefinition.name"/>
          <slicing>
            <discriminator>
              <type value="value"/>
              <path value="type"/>
            </discriminator>
            <description value="Slice based on value pattern"/>
            <rules value="closed"/>
          </slicing>
          <short value="Substance Name"/>
          <definition
                      value="Substance Name is identified by its Substance Type.
    Substance Type | Product Part Ingredient Name Type: Identifies the source that assigned the product ingredient name. [Source: SME Defined]
    Examples: GSRS Preferred Term, Systematic Name, INN, USP/NF"/>
          <min value="1"/>
          <max value="*"/>
          <base>
            <path value="SubstanceDefinition.name"/>
            <min value="0"/>
            <max value="*"/>
          </base>
          <type>
            <code value="BackboneElement"/>
          </type>
          <constraint>
            <key value="ele-1"/>
            <severity value="error"/>
            <human value="All FHIR elements must have a @value or children"/>
            <expression
                        value="hasValue() or (children().count() &gt; id.count())"/>
            <source value="http://hl7.org/fhir/StructureDefinition/Element"/>
          </constraint>
          <constraint>
            <key value="cmc-name-preferred"/>
            <severity value="error"/>
            <human value="Name.preferred: at most one = true"/>
            <expression value="select(preferred = true).count() &lt; 2"/>
            <source
                    value="http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pqcmc-component-substance"/>
          </constraint>
          <mustSupport value="true"/>
          <isModifier value="false"/>
          <isSummary value="true"/>
          <mapping>
            <identity value="idmp-substance"/>
            <map value="Substance.Substance_Name"/>
          </mapping>
        </element>
        <element id="SubstanceDefinition.name.id">
          <path value="SubstanceDefinition.name.id"/>
          <representation value="xmlAttr"/>
          <short value="Unique id for inter-element referencing"/>
          <definition
                      value="Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces."/>
          <min value="0"/>
          <max value="1"/>
          <base>
            <path value="Element.id"/>
            <min value="0"/>
            <max value="1"/>
          </base>
          <type>
            <extension
                       url="http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type">
              <valueUrl value="string"/>
            </extension>
            <code value="http://hl7.org/fhirpath/System.String"/>
          </type>
          <condition value="ele-1"/>
          <isModifier value="false"/>
          <isSummary value="false"/>
          <mapping>
            <identity value="rim"/>
            <map value="n/a"/>
          </mapping>
        </element>
        <element id="SubstanceDefinition.name.extension">
          <path value="SubstanceDefinition.name.extension"/>
          <short value="Additional content defined by implementations"/>
          <definition
                      value="May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension."/>
          <comment
                   value="There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions.  The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone."/>
          <alias value="extensions"/>
          <alias value="user content"/>
          <min value="0"/>
          <max value="*"/>
          <base>
            <path value="Element.extension"/>
            <min value="0"/>
            <max value="*"/>
          </base>
          <type>
            <code value="Extension"/>
          </type>
          <constraint>
            <key value="ele-1"/>
            <severity value="error"/>
            <human value="All FHIR elements must have a @value or children"/>
            <expression
                        value="hasValue() or (children().count() &gt; id.count())"/>
            <source value="http://hl7.org/fhir/StructureDefinition/Element"/>
          </constraint>
          <constraint>
            <key value="ext-1"/>
            <severity value="error"/>
            <human value="Must have either extensions or value[x], not both"/>
            <expression value="extension.exists() != value.exists()"/>
            <source value="http://hl7.org/fhir/StructureDefinition/Extension"/>
          </constraint>
          <isModifier value="false"/>
          <isSummary value="false"/>
          <mapping>
            <identity value="rim"/>
            <map value="n/a"/>
          </mapping>
        </element>
        <element id="SubstanceDefinition.name.modifierExtension">
          <path value="SubstanceDefinition.name.modifierExtension"/>
          <short value="Extensions that cannot be ignored even if unrecognized"/>
          <definition
                      value="May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.

    Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself)."/>
          <comment
                   value="There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions.  The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone."/>
          <requirements
                        value="Modifier extensions allow for extensions that *cannot* be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored.  This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the [definition of modifier extensions](http://hl7.org/fhir/R5/extensibility.html#modifierExtension)."/>
          <alias value="extensions"/>
          <alias value="user content"/>
          <alias value="modifiers"/>
          <min value="0"/>
          <max value="*"/>
          <base>
            <path value="BackboneElement.modifierExtension"/>
            <min value="0"/>
            <max value="*"/>
          </base>
          <type>
            <code value="Extension"/>
          </type>
          <constraint>
            <key value="ele-1"/>
            <severity value="error"/>
            <human value="All FHIR elements must have a @value or children"/>
            <expression
                        value="hasValue() or (children().count() &gt; id.count())"/>
            <source value="http://hl7.org/fhir/StructureDefinition/Element"/>
          </constraint>
          <constraint>
            <key value="ext-1"/>
            <severity value="error"/>
            <human value="Must have either extensions or value[x], not both"/>
            <expression value="extension.exists() != value.exists()"/>
            <source value="http://hl7.org/fhir/StructureDefinition/Extension"/>
          </constraint>
          <isModifier value="true"/>
          <isModifierReason
                            value="Modifier extensions are expected to modify the meaning or interpretation of the element that contains them"/>
          <isSummary value="true"/>
          <mapping>
            <identity value="rim"/>
            <map value="N/A"/>
          </mapping>
        </element>
        <element id="SubstanceDefinition.name.name">
          <path value="SubstanceDefinition.name.name"/>
          <short value="The actual name"/>
          <definition value="The actual name."/>
          <min value="1"/>
          <max value="1"/>
          <base>
            <path value="SubstanceDefinition.name.name"/>
            <min value="1"/>
            <max value="1"/>
          </base>
          <type>
            <code value="string"/>
          </type>
          <constraint>
            <key value="ele-1"/>
            <severity value="error"/>
            <human value="All FHIR elements must have a @value or children"/>
            <expression
                        value="hasValue() or (children().count() &gt; id.count())"/>
            <source value="http://hl7.org/fhir/StructureDefinition/Element"/>
          </constraint>
          <mustSupport value="false"/>
          <isModifier value="false"/>
          <isSummary value="true"/>
          <mapping>
            <identity value="idmp-substance"/>
            <map value="Substance_Name.Substance_Name"/>
          </mapping>
        </element>
        <element id="SubstanceDefinition.name.type">
          <path value="SubstanceDefinition.name.type"/>
          <short value="Name type e.g. 'systematic',  'scientific, 'brand'"/>
          <definition
                      value="Name type, for example 'systematic',  'scientific, 'brand'."/>
          <min value="0"/>
          <max value="1"/>
          <base>
            <path value="SubstanceDefinition.name.type"/>
            <min value="0"/>
            <max value="1"/>
          </base>
          <type>
            <code value="CodeableConcept"/>
          </type>
          <constraint>
            <key value="ele-1"/>
            <severity value="error"/>
            <human value="All FHIR elements must have a @value or children"/>
            <expression
                        value="hasValue() or (children().count() &gt; id.count())"/>
            <source value="http://hl7.org/fhir/StructureDefinition/Element"/>
          </constraint>
          <mustSupport value="false"/>
          <isModifier value="false"/>
          <isSummary value="true"/>
          <binding>
            <strength value="required"/>
            <valueSet
                      value="http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-substance-name-type"/>
          </binding>
          <mapping>
            <identity value="idmp-substance"/>
            <map value="Substance_Name.Substance_Name_Type"/>
          </mapping>
        </element>
        <element id="SubstanceDefinition.name.status">
          <path value="SubstanceDefinition.name.status"/>
          <short value="The status of the name e.g. 'current', 'proposed'"/>
          <definition
                      value="The status of the name, for example 'current', 'proposed'."/>
          <min value="0"/>
          <max value="1"/>
          <base>
            <path value="SubstanceDefinition.name.status"/>
            <min value="0"/>
            <max value="1"/>
          </base>
          <type>
            <code value="CodeableConcept"/>
          </type>
          <constraint>
            <key value="ele-1"/>
            <severity value="error"/>
            <human value="All FHIR elements must have a @value or children"/>
            <expression
                        value="hasValue() or (children().count() &gt; id.count())"/>
            <source value="http://hl7.org/fhir/StructureDefinition/Element"/>
          </constraint>
          <mustSupport value="false"/>
          <isModifier value="false"/>
          <isSummary value="true"/>
          <binding>
            <extension
                       url="http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName">
              <valueString value="PublicationStatus"/>
            </extension>
            <strength value="preferred"/>
            <description value="The lifecycle status of an artifact."/>
            <valueSet value="http://hl7.org/fhir/ValueSet/publication-status"/>
          </binding>
          <mapping>
            <identity value="idmp-substance"/>
            <map value="n/a"/>
          </mapping>
        </element>
        <element id="SubstanceDefinition.name.preferred">
          <path value="SubstanceDefinition.name.preferred"/>
          <short value="True when the name type is Substance Name"/>
          <definition value="If this is the preferred name for this substance."/>
          <min value="0"/>
          <max value="1"/>
          <base>
            <path value="SubstanceDefinition.name.preferred"/>
            <min value="0"/>
            <max value="1"/>
          </base>
          <type>
            <code value="boolean"/>
          </type>
          <meaningWhenMissing
                              value="If this value is not present, there is no statement being made about whether this is the preferred name or not. No inference can be made"/>
          <constraint>
            <key value="ele-1"/>
            <severity value="error"/>
            <human value="All FHIR elements must have a @value or children"/>
            <expression
                        value="hasValue() or (children().count() &gt; id.count())"/>
            <source value="http://hl7.org/fhir/StructureDefinition/Element"/>
          </constraint>
          <mustSupport value="true"/>
          <isModifier value="false"/>
          <isSummary value="true"/>
          <mapping>
            <identity value="idmp-substance"/>
            <map value="n/a"/>
          </mapping>
        </element>
        <element id="SubstanceDefinition.name.language">
          <path value="SubstanceDefinition.name.language"/>
          <short value="Human language that the name is written in"/>
          <definition value="Human language that the name is written in."/>
          <min value="0"/>
          <max value="*"/>
          <base>
            <path value="SubstanceDefinition.name.language"/>
            <min value="0"/>
            <max value="*"/>
          </base>
          <type>
            <code value="CodeableConcept"/>
          </type>
          <constraint>
            <key value="ele-1"/>
            <severity value="error"/>
            <human value="All FHIR elements must have a @value or children"/>
            <expression
                        value="hasValue() or (children().count() &gt; id.count())"/>
            <source value="http://hl7.org/fhir/StructureDefinition/Element"/>
          </constraint>
          <mustSupport value="false"/>
          <isModifier value="false"/>
          <isSummary value="true"/>
          <binding>
            <extension
                       url="http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName">
              <valueString value="Language"/>
            </extension>
            <strength value="required"/>
            <description value="IETF language tag for a human language"/>
            <valueSet value="http://hl7.org/fhir/ValueSet/all-languages|5.0.0"/>
            <additional>
              <purpose value="starter"/>
              <valueSet value="http://hl7.org/fhir/ValueSet/languages"/>
            </additional>
          </binding>
          <mapping>
            <identity value="idmp-substance"/>
            <map value="Substance_Name.Language"/>
          </mapping>
        </element>
        <element id="SubstanceDefinition.name.domain">
          <path value="SubstanceDefinition.name.domain"/>
          <short
                 value="The use context of this name e.g. as an active ingredient or as a food colour additive"/>
          <definition
                      value="The use context of this name for example if there is a different name a drug active ingredient as opposed to a food colour additive."/>
          <min value="0"/>
          <max value="*"/>
          <base>
            <path value="SubstanceDefinition.name.domain"/>
            <min value="0"/>
            <max value="*"/>
          </base>
          <type>
            <code value="CodeableConcept"/>
          </type>
          <constraint>
            <key value="ele-1"/>
            <severity value="error"/>
            <human value="All FHIR elements must have a @value or children"/>
            <expression
                        value="hasValue() or (children().count() &gt; id.count())"/>
            <source value="http://hl7.org/fhir/StructureDefinition/Element"/>
          </constraint>
          <mustSupport value="false"/>
          <isModifier value="false"/>
          <isSummary value="true"/>
          <binding>
            <extension
                       url="http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName">
              <valueString value="SubstanceNameDomain"/>
            </extension>
            <strength value="example"/>
            <description
                         value="The use context of a substance name for example if there is a different name when used as a drug active ingredient as opposed to a food colour additive."/>
            <valueSet value="http://hl7.org/fhir/ValueSet/substance-name-domain"/>
          </binding>
          <mapping>
            <identity value="idmp-substance"/>
            <map value="Substance_Name.Substance_Name_Domain"/>
          </mapping>
        </element>
        <element id="SubstanceDefinition.name.jurisdiction">
          <path value="SubstanceDefinition.name.jurisdiction"/>
          <short value="The jurisdiction where this name applies"/>
          <definition value="The jurisdiction where this name applies."/>
          <min value="0"/>
          <max value="*"/>
          <base>
            <path value="SubstanceDefinition.name.jurisdiction"/>
            <min value="0"/>
            <max value="*"/>
          </base>
          <type>
            <code value="CodeableConcept"/>
          </type>
          <constraint>
            <key value="ele-1"/>
            <severity value="error"/>
            <human value="All FHIR elements must have a @value or children"/>
            <expression
                        value="hasValue() or (children().count() &gt; id.count())"/>
            <source value="http://hl7.org/fhir/StructureDefinition/Element"/>
          </constraint>
          <mustSupport value="false"/>
          <isModifier value="false"/>
          <isSummary value="true"/>
          <binding>
            <extension
                       url="http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName">
              <valueString value="Jurisdiction"/>
            </extension>
            <strength value="example"/>
            <description value="Jurisdiction codes"/>
            <valueSet value="http://hl7.org/fhir/ValueSet/jurisdiction"/>
          </binding>
          <mapping>
            <identity value="idmp-substance"/>
            <map value="Substance_Name.Jurisdiction"/>
          </mapping>
        </element>
        <element id="SubstanceDefinition.name.synonym">
          <path value="SubstanceDefinition.name.synonym"/>
          <short
                 value="A synonym of this particular name, by which the substance is also known"/>
          <definition
                      value="A synonym of this particular name, by which the substance is also known."/>
          <min value="0"/>
          <max value="*"/>
          <base>
            <path value="SubstanceDefinition.name.synonym"/>
            <min value="0"/>
            <max value="*"/>
          </base>
          <contentReference
                            value="http://hl7.org/fhir/StructureDefinition/SubstanceDefinition#SubstanceDefinition.name"/>
          <constraint>
            <key value="ele-1"/>
            <severity value="error"/>
            <human value="All FHIR elements must have a @value or children"/>
            <expression
                        value="hasValue() or (children().count() &gt; id.count())"/>
            <source value="http://hl7.org/fhir/StructureDefinition/Element"/>
          </constraint>
          <mustSupport value="false"/>
          <isModifier value="false"/>
          <isSummary value="true"/>
          <mapping>
            <identity value="idmp-substance"/>
            <map value="n/a"/>
          </mapping>
        </element>
        <element id="SubstanceDefinition.name.translation">
          <path value="SubstanceDefinition.name.translation"/>
          <short value="A translation for this name into another human language"/>
          <definition
                      value="A translation for this name into another human language."/>
          <min value="0"/>
          <max value="*"/>
          <base>
            <path value="SubstanceDefinition.name.translation"/>
            <min value="0"/>
            <max value="*"/>
          </base>
          <contentReference
                            value="http://hl7.org/fhir/StructureDefinition/SubstanceDefinition#SubstanceDefinition.name"/>
          <constraint>
            <key value="ele-1"/>
            <severity value="error"/>
            <human value="All FHIR elements must have a @value or children"/>
            <expression
                        value="hasValue() or (children().count() &gt; id.count())"/>
            <source value="http://hl7.org/fhir/StructureDefinition/Element"/>
          </constraint>
          <mustSupport value="false"/>
          <isModifier value="false"/>
          <isSummary value="true"/>
          <mapping>
            <identity value="idmp-substance"/>
            <map value="n/a"/>
          </mapping>
        </element>
        <element id="SubstanceDefinition.name.official">
          <path value="SubstanceDefinition.name.official"/>
          <short value="Details of the official nature of this name"/>
          <definition value="Details of the official nature of this name."/>
          <min value="0"/>
          <max value="*"/>
          <base>
            <path value="SubstanceDefinition.name.official"/>
            <min value="0"/>
            <max value="*"/>
          </base>
          <type>
            <code value="BackboneElement"/>
          </type>
          <constraint>
            <key value="ele-1"/>
            <severity value="error"/>
            <human value="All FHIR elements must have a @value or children"/>
            <expression
                        value="hasValue() or (children().count() &gt; id.count())"/>
            <source value="http://hl7.org/fhir/StructureDefinition/Element"/>
          </constraint>
          <mustSupport value="false"/>
          <isModifier value="false"/>
          <isSummary value="true"/>
          <mapping>
            <identity value="idmp-substance"/>
            <map value="Substance_Name.Official_Name"/>
          </mapping>
        </element>
        <element id="SubstanceDefinition.name.official.id">
          <path value="SubstanceDefinition.name.official.id"/>
          <representation value="xmlAttr"/>
          <short value="Unique id for inter-element referencing"/>
          <definition
                      value="Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces."/>
          <min value="0"/>
          <max value="1"/>
          <base>
            <path value="Element.id"/>
            <min value="0"/>
            <max value="1"/>
          </base>
          <type>
            <extension
                       url="http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type">
              <valueUrl value="string"/>
            </extension>
            <code value="http://hl7.org/fhirpath/System.String"/>
          </type>
          <condition value="ele-1"/>
          <isModifier value="false"/>
          <isSummary value="false"/>
          <mapping>
            <identity value="rim"/>
            <map value="n/a"/>
          </mapping>
        </element>
        <element id="SubstanceDefinition.name.official.extension">
          <path value="SubstanceDefinition.name.official.extension"/>
          <short value="Additional content defined by implementations"/>
          <definition
                      value="May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension."/>
          <comment
                   value="There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions.  The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone."/>
          <alias value="extensions"/>
          <alias value="user content"/>
          <min value="0"/>
          <max value="*"/>
          <base>
            <path value="Element.extension"/>
            <min value="0"/>
            <max value="*"/>
          </base>
          <type>
            <code value="Extension"/>
          </type>
          <constraint>
            <key value="ele-1"/>
            <severity value="error"/>
            <human value="All FHIR elements must have a @value or children"/>
            <expression
                        value="hasValue() or (children().count() &gt; id.count())"/>
            <source value="http://hl7.org/fhir/StructureDefinition/Element"/>
          </constraint>
          <constraint>
            <key value="ext-1"/>
            <severity value="error"/>
            <human value="Must have either extensions or value[x], not both"/>
            <expression value="extension.exists() != value.exists()"/>
            <source value="http://hl7.org/fhir/StructureDefinition/Extension"/>
          </constraint>
          <isModifier value="false"/>
          <isSummary value="false"/>
          <mapping>
            <identity value="rim"/>
            <map value="n/a"/>
          </mapping>
        </element>
        <element id="SubstanceDefinition.name.official.modifierExtension">
          <path value="SubstanceDefinition.name.official.modifierExtension"/>
          <short value="Extensions that cannot be ignored even if unrecognized"/>
          <definition
                      value="May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.

    Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself)."/>
          <comment
                   value="There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions.  The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone."/>
          <requirements
                        value="Modifier extensions allow for extensions that *cannot* be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored.  This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the [definition of modifier extensions](http://hl7.org/fhir/R5/extensibility.html#modifierExtension)."/>
          <alias value="extensions"/>
          <alias value="user content"/>
          <alias value="modifiers"/>
          <min value="0"/>
          <max value="*"/>
          <base>
            <path value="BackboneElement.modifierExtension"/>
            <min value="0"/>
            <max value="*"/>
          </base>
          <type>
            <code value="Extension"/>
          </type>
          <constraint>
            <key value="ele-1"/>
            <severity value="error"/>
            <human value="All FHIR elements must have a @value or children"/>
            <expression
                        value="hasValue() or (children().count() &gt; id.count())"/>
            <source value="http://hl7.org/fhir/StructureDefinition/Element"/>
          </constraint>
          <constraint>
            <key value="ext-1"/>
            <severity value="error"/>
            <human value="Must have either extensions or value[x], not both"/>
            <expression value="extension.exists() != value.exists()"/>
            <source value="http://hl7.org/fhir/StructureDefinition/Extension"/>
          </constraint>
          <isModifier value="true"/>
          <isModifierReason
                            value="Modifier extensions are expected to modify the meaning or interpretation of the element that contains them"/>
          <isSummary value="true"/>
          <mapping>
            <identity value="rim"/>
            <map value="N/A"/>
          </mapping>
        </element>
        <element id="SubstanceDefinition.name.official.authority">
          <path value="SubstanceDefinition.name.official.authority"/>
          <short value="Which authority uses this official name"/>
          <definition value="Which authority uses this official name."/>
          <min value="0"/>
          <max value="1"/>
          <base>
            <path value="SubstanceDefinition.name.official.authority"/>
            <min value="0"/>
            <max value="1"/>
          </base>
          <type>
            <code value="CodeableConcept"/>
          </type>
          <constraint>
            <key value="ele-1"/>
            <severity value="error"/>
            <human value="All FHIR elements must have a @value or children"/>
            <expression
                        value="hasValue() or (children().count() &gt; id.count())"/>
            <source value="http://hl7.org/fhir/StructureDefinition/Element"/>
          </constraint>
          <mustSupport value="false"/>
          <isModifier value="false"/>
          <isSummary value="true"/>
          <binding>
            <extension
                       url="http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName">
              <valueString value="SubstanceNameAuthority"/>
            </extension>
            <strength value="preferred"/>
            <description value="An authority that officates substance names."/>
            <valueSet
                      value="http://hl7.org/fhir/ValueSet/substance-name-authority"/>
          </binding>
          <mapping>
            <identity value="idmp-substance"/>
            <map value="Official_Name.Official_Name_Type"/>
          </mapping>
        </element>
        <element id="SubstanceDefinition.name.official.status">
          <path value="SubstanceDefinition.name.official.status"/>
          <short
                 value="The status of the official name, for example 'draft', 'active'"/>
          <definition
                      value="The status of the official name, for example 'draft', 'active', 'retired'."/>
          <min value="0"/>
          <max value="1"/>
          <base>
            <path value="SubstanceDefinition.name.official.status"/>
            <min value="0"/>
            <max value="1"/>
          </base>
          <type>
            <code value="CodeableConcept"/>
          </type>
          <constraint>
            <key value="ele-1"/>
            <severity value="error"/>
            <human value="All FHIR elements must have a @value or children"/>
            <expression
                        value="hasValue() or (children().count() &gt; id.count())"/>
            <source value="http://hl7.org/fhir/StructureDefinition/Element"/>
          </constraint>
          <mustSupport value="false"/>
          <isModifier value="false"/>
          <isSummary value="true"/>
          <binding>
            <extension
                       url="http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName">
              <valueString value="PublicationStatus"/>
            </extension>
            <strength value="preferred"/>
            <description value="The lifecycle status of an artifact."/>
            <valueSet value="http://hl7.org/fhir/ValueSet/publication-status"/>
          </binding>
          <mapping>
            <identity value="idmp-substance"/>
            <map value="Official_Name.Official_Name_Status"/>
          </mapping>
        </element>
        <element id="SubstanceDefinition.name.official.date">
          <path value="SubstanceDefinition.name.official.date"/>
          <short value="Date of official name change"/>
          <definition value="Date of the official name change."/>
          <min value="0"/>
          <max value="1"/>
          <base>
            <path value="SubstanceDefinition.name.official.date"/>
            <min value="0"/>
            <max value="1"/>
          </base>
          <type>
            <code value="dateTime"/>
          </type>
          <constraint>
            <key value="ele-1"/>
            <severity value="error"/>
            <human value="All FHIR elements must have a @value or children"/>
            <expression
                        value="hasValue() or (children().count() &gt; id.count())"/>
            <source value="http://hl7.org/fhir/StructureDefinition/Element"/>
          </constraint>
          <mustSupport value="false"/>
          <isModifier value="false"/>
          <isSummary value="true"/>
          <mapping>
            <identity value="idmp-substance"/>
            <map value="Official_Name.Official_Name_Status_Change_Date"/>
          </mapping>
        </element>
        <element id="SubstanceDefinition.name.source">
          <path value="SubstanceDefinition.name.source"/>
          <short value="Supporting literature"/>
          <definition value="Supporting literature."/>
          <min value="0"/>
          <max value="*"/>
          <base>
            <path value="SubstanceDefinition.name.source"/>
            <min value="0"/>
            <max value="*"/>
          </base>
          <type>
            <code value="Reference"/>
            <targetProfile
                           value="http://hl7.org/fhir/StructureDefinition/DocumentReference"/>
          </type>
          <constraint>
            <key value="ele-1"/>
            <severity value="error"/>
            <human value="All FHIR elements must have a @value or children"/>
            <expression
                        value="hasValue() or (children().count() &gt; id.count())"/>
            <source value="http://hl7.org/fhir/StructureDefinition/Element"/>
          </constraint>
          <mustSupport value="false"/>
          <isModifier value="false"/>
          <isSummary value="true"/>
          <mapping>
            <identity value="idmp-substance"/>
            <map value="Substance_Name.Reference_Source"/>
          </mapping>
        </element>
        <element id="SubstanceDefinition.name:sub">
          <path value="SubstanceDefinition.name"/>
          <sliceName value="sub"/>
          <short value="Names applicable to this substance"/>
          <definition value="Names applicable to this substance."/>
          <min value="0"/>
          <max value="1"/>
          <base>
            <path value="SubstanceDefinition.name"/>
            <min value="0"/>
            <max value="*"/>
          </base>
          <type>
            <code value="BackboneElement"/>
          </type>
          <constraint>
            <key value="ele-1"/>
            <severity value="error"/>
            <human value="All FHIR elements must have a @value or children"/>
            <expression
                        value="hasValue() or (children().count() &gt; id.count())"/>
            <source value="http://hl7.org/fhir/StructureDefinition/Element"/>
          </constraint>
          <mustSupport value="true"/>
          <isModifier value="false"/>
          <isSummary value="true"/>
          <mapping>
            <identity value="idmp-substance"/>
            <map value="Substance.Substance_Name"/>
          </mapping>
        </element>
        <element id="SubstanceDefinition.name:sub.id">
          <path value="SubstanceDefinition.name.id"/>
          <representation value="xmlAttr"/>
          <short value="Unique id for inter-element referencing"/>
          <definition
                      value="Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces."/>
          <min value="0"/>
          <max value="1"/>
          <base>
            <path value="Element.id"/>
            <min value="0"/>
            <max value="1"/>
          </base>
          <type>
            <extension
                       url="http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type">
              <valueUrl value="string"/>
            </extension>
            <code value="http://hl7.org/fhirpath/System.String"/>
          </type>
          <condition value="ele-1"/>
          <isModifier value="false"/>
          <isSummary value="false"/>
          <mapping>
            <identity value="rim"/>
            <map value="n/a"/>
          </mapping>
        </element>
        <element id="SubstanceDefinition.name:sub.extension">
          <path value="SubstanceDefinition.name.extension"/>
          <short value="Additional content defined by implementations"/>
          <definition
                      value="May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension."/>
          <comment
                   value="There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions.  The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone."/>
          <alias value="extensions"/>
          <alias value="user content"/>
          <min value="0"/>
          <max value="*"/>
          <base>
            <path value="Element.extension"/>
            <min value="0"/>
            <max value="*"/>
          </base>
          <type>
            <code value="Extension"/>
          </type>
          <constraint>
            <key value="ele-1"/>
            <severity value="error"/>
            <human value="All FHIR elements must have a @value or children"/>
            <expression
                        value="hasValue() or (children().count() &gt; id.count())"/>
            <source value="http://hl7.org/fhir/StructureDefinition/Element"/>
          </constraint>
          <constraint>
            <key value="ext-1"/>
            <severity value="error"/>
            <human value="Must have either extensions or value[x], not both"/>
            <expression value="extension.exists() != value.exists()"/>
            <source value="http://hl7.org/fhir/StructureDefinition/Extension"/>
          </constraint>
          <isModifier value="false"/>
          <isSummary value="false"/>
          <mapping>
            <identity value="rim"/>
            <map value="n/a"/>
          </mapping>
        </element>
        <element id="SubstanceDefinition.name:sub.modifierExtension">
          <path value="SubstanceDefinition.name.modifierExtension"/>
          <short value="Extensions that cannot be ignored even if unrecognized"/>
          <definition
                      value="May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.

    Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself)."/>
          <comment
                   value="There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions.  The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone."/>
          <requirements
                        value="Modifier extensions allow for extensions that *cannot* be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored.  This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the [definition of modifier extensions](http://hl7.org/fhir/R5/extensibility.html#modifierExtension)."/>
          <alias value="extensions"/>
          <alias value="user content"/>
          <alias value="modifiers"/>
          <min value="0"/>
          <max value="*"/>
          <base>
            <path value="BackboneElement.modifierExtension"/>
            <min value="0"/>
            <max value="*"/>
          </base>
          <type>
            <code value="Extension"/>
          </type>
          <constraint>
            <key value="ele-1"/>
            <severity value="error"/>
            <human value="All FHIR elements must have a @value or children"/>
            <expression
                        value="hasValue() or (children().count() &gt; id.count())"/>
            <source value="http://hl7.org/fhir/StructureDefinition/Element"/>
          </constraint>
          <constraint>
            <key value="ext-1"/>
            <severity value="error"/>
            <human value="Must have either extensions or value[x], not both"/>
            <expression value="extension.exists() != value.exists()"/>
            <source value="http://hl7.org/fhir/StructureDefinition/Extension"/>
          </constraint>
          <isModifier value="true"/>
          <isModifierReason
                            value="Modifier extensions are expected to modify the meaning or interpretation of the element that contains them"/>
          <isSummary value="true"/>
          <mapping>
            <identity value="rim"/>
            <map value="N/A"/>
          </mapping>
        </element>
        <element id="SubstanceDefinition.name:sub.name">
          <path value="SubstanceDefinition.name.name"/>
          <short value="Generic Name"/>
          <definition
                      value="A non-branded nor registered name that meant for common use."/>
          <min value="1"/>
          <max value="1"/>
          <base>
            <path value="SubstanceDefinition.name.name"/>
            <min value="1"/>
            <max value="1"/>
          </base>
          <type>
            <code value="string"/>
          </type>
          <constraint>
            <key value="ele-1"/>
            <severity value="error"/>
            <human value="All FHIR elements must have a @value or children"/>
            <expression
                        value="hasValue() or (children().count() &gt; id.count())"/>
            <source value="http://hl7.org/fhir/StructureDefinition/Element"/>
          </constraint>
          <mustSupport value="true"/>
          <isModifier value="false"/>
          <isSummary value="true"/>
          <mapping>
            <identity value="idmp-substance"/>
            <map value="Substance_Name.Substance_Name"/>
          </mapping>
        </element>
        <element id="SubstanceDefinition.name:sub.type">
          <path value="SubstanceDefinition.name.type"/>
          <short value="Name type e.g. 'systematic',  'scientific, 'brand'"/>
          <definition
                      value="Name type, for example 'systematic',  'scientific, 'brand'."/>
          <min value="1"/>
          <max value="1"/>
          <base>
            <path value="SubstanceDefinition.name.type"/>
            <min value="0"/>
            <max value="1"/>
          </base>
          <type>
            <code value="CodeableConcept"/>
          </type>
          <patternCodeableConcept>
            <coding>
              <system value="http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl"/>
              <code value="C97054"/>
              <display value="Generic Name"/>
            </coding>
          </patternCodeableConcept>
          <constraint>
            <key value="ele-1"/>
            <severity value="error"/>
            <human value="All FHIR elements must have a @value or children"/>
            <expression
                        value="hasValue() or (children().count() &gt; id.count())"/>
            <source value="http://hl7.org/fhir/StructureDefinition/Element"/>
          </constraint>
          <mustSupport value="true"/>
          <isModifier value="false"/>
          <isSummary value="true"/>
          <binding>
            <strength value="required"/>
            <valueSet
                      value="http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-substance-name-type"/>
          </binding>
          <mapping>
            <identity value="idmp-substance"/>
            <map value="Substance_Name.Substance_Name_Type"/>
          </mapping>
        </element>
        <element id="SubstanceDefinition.name:sub.status">
          <path value="SubstanceDefinition.name.status"/>
          <short value="The status of the name e.g. 'current', 'proposed'"/>
          <definition
                      value="The status of the name, for example 'current', 'proposed'."/>
          <min value="0"/>
          <max value="1"/>
          <base>
            <path value="SubstanceDefinition.name.status"/>
            <min value="0"/>
            <max value="1"/>
          </base>
          <type>
            <code value="CodeableConcept"/>
          </type>
          <constraint>
            <key value="ele-1"/>
            <severity value="error"/>
            <human value="All FHIR elements must have a @value or children"/>
            <expression
                        value="hasValue() or (children().count() &gt; id.count())"/>
            <source value="http://hl7.org/fhir/StructureDefinition/Element"/>
          </constraint>
          <mustSupport value="false"/>
          <isModifier value="false"/>
          <isSummary value="true"/>
          <binding>
            <extension
                       url="http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName">
              <valueString value="PublicationStatus"/>
            </extension>
            <strength value="preferred"/>
            <description value="The lifecycle status of an artifact."/>
            <valueSet value="http://hl7.org/fhir/ValueSet/publication-status"/>
          </binding>
          <mapping>
            <identity value="idmp-substance"/>
            <map value="n/a"/>
          </mapping>
        </element>
        <element id="SubstanceDefinition.name:sub.preferred">
          <path value="SubstanceDefinition.name.preferred"/>
          <short value="True when the name type is Substance Name"/>
          <definition value="If this is the preferred name for this substance."/>
          <min value="0"/>
          <max value="1"/>
          <base>
            <path value="SubstanceDefinition.name.preferred"/>
            <min value="0"/>
            <max value="1"/>
          </base>
          <type>
            <code value="boolean"/>
          </type>
          <meaningWhenMissing
                              value="If this value is not present, there is no statement being made about whether this is the preferred name or not. No inference can be made"/>
          <constraint>
            <key value="ele-1"/>
            <severity value="error"/>
            <human value="All FHIR elements must have a @value or children"/>
            <expression
                        value="hasValue() or (children().count() &gt; id.count())"/>
            <source value="http://hl7.org/fhir/StructureDefinition/Element"/>
          </constraint>
          <mustSupport value="true"/>
          <isModifier value="false"/>
          <isSummary value="true"/>
          <mapping>
            <identity value="idmp-substance"/>
            <map value="n/a"/>
          </mapping>
        </element>
        <element id="SubstanceDefinition.name:sub.language">
          <path value="SubstanceDefinition.name.language"/>
          <short value="Human language that the name is written in"/>
          <definition value="Human language that the name is written in."/>
          <min value="0"/>
          <max value="*"/>
          <base>
            <path value="SubstanceDefinition.name.language"/>
            <min value="0"/>
            <max value="*"/>
          </base>
          <type>
            <code value="CodeableConcept"/>
          </type>
          <constraint>
            <key value="ele-1"/>
            <severity value="error"/>
            <human value="All FHIR elements must have a @value or children"/>
            <expression
                        value="hasValue() or (children().count() &gt; id.count())"/>
            <source value="http://hl7.org/fhir/StructureDefinition/Element"/>
          </constraint>
          <mustSupport value="false"/>
          <isModifier value="false"/>
          <isSummary value="true"/>
          <binding>
            <extension
                       url="http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName">
              <valueString value="Language"/>
            </extension>
            <strength value="required"/>
            <description value="IETF language tag for a human language"/>
            <valueSet value="http://hl7.org/fhir/ValueSet/all-languages|5.0.0"/>
            <additional>
              <purpose value="starter"/>
              <valueSet value="http://hl7.org/fhir/ValueSet/languages"/>
            </additional>
          </binding>
          <mapping>
            <identity value="idmp-substance"/>
            <map value="Substance_Name.Language"/>
          </mapping>
        </element>
        <element id="SubstanceDefinition.name:sub.domain">
          <path value="SubstanceDefinition.name.domain"/>
          <short
                 value="The use context of this name e.g. as an active ingredient or as a food colour additive"/>
          <definition
                      value="The use context of this name for example if there is a different name a drug active ingredient as opposed to a food colour additive."/>
          <min value="0"/>
          <max value="*"/>
          <base>
            <path value="SubstanceDefinition.name.domain"/>
            <min value="0"/>
            <max value="*"/>
          </base>
          <type>
            <code value="CodeableConcept"/>
          </type>
          <constraint>
            <key value="ele-1"/>
            <severity value="error"/>
            <human value="All FHIR elements must have a @value or children"/>
            <expression
                        value="hasValue() or (children().count() &gt; id.count())"/>
            <source value="http://hl7.org/fhir/StructureDefinition/Element"/>
          </constraint>
          <mustSupport value="false"/>
          <isModifier value="false"/>
          <isSummary value="true"/>
          <binding>
            <extension
                       url="http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName">
              <valueString value="SubstanceNameDomain"/>
            </extension>
            <strength value="example"/>
            <description
                         value="The use context of a substance name for example if there is a different name when used as a drug active ingredient as opposed to a food colour additive."/>
            <valueSet value="http://hl7.org/fhir/ValueSet/substance-name-domain"/>
          </binding>
          <mapping>
            <identity value="idmp-substance"/>
            <map value="Substance_Name.Substance_Name_Domain"/>
          </mapping>
        </element>
        <element id="SubstanceDefinition.name:sub.jurisdiction">
          <path value="SubstanceDefinition.name.jurisdiction"/>
          <short value="The jurisdiction where this name applies"/>
          <definition value="The jurisdiction where this name applies."/>
          <min value="0"/>
          <max value="*"/>
          <base>
            <path value="SubstanceDefinition.name.jurisdiction"/>
            <min value="0"/>
            <max value="*"/>
          </base>
          <type>
            <code value="CodeableConcept"/>
          </type>
          <constraint>
            <key value="ele-1"/>
            <severity value="error"/>
            <human value="All FHIR elements must have a @value or children"/>
            <expression
                        value="hasValue() or (children().count() &gt; id.count())"/>
            <source value="http://hl7.org/fhir/StructureDefinition/Element"/>
          </constraint>
          <mustSupport value="false"/>
          <isModifier value="false"/>
          <isSummary value="true"/>
          <binding>
            <extension
                       url="http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName">
              <valueString value="Jurisdiction"/>
            </extension>
            <strength value="example"/>
            <description value="Jurisdiction codes"/>
            <valueSet value="http://hl7.org/fhir/ValueSet/jurisdiction"/>
          </binding>
          <mapping>
            <identity value="idmp-substance"/>
            <map value="Substance_Name.Jurisdiction"/>
          </mapping>
        </element>
        <element id="SubstanceDefinition.name:sub.synonym">
          <path value="SubstanceDefinition.name.synonym"/>
          <short
                 value="A synonym of this particular name, by which the substance is also known"/>
          <definition
                      value="A synonym of this particular name, by which the substance is also known."/>
          <min value="0"/>
          <max value="*"/>
          <base>
            <path value="SubstanceDefinition.name.synonym"/>
            <min value="0"/>
            <max value="*"/>
          </base>
          <contentReference
                            value="http://hl7.org/fhir/StructureDefinition/SubstanceDefinition#SubstanceDefinition.name"/>
          <constraint>
            <key value="ele-1"/>
            <severity value="error"/>
            <human value="All FHIR elements must have a @value or children"/>
            <expression
                        value="hasValue() or (children().count() &gt; id.count())"/>
            <source value="http://hl7.org/fhir/StructureDefinition/Element"/>
          </constraint>
          <mustSupport value="false"/>
          <isModifier value="false"/>
          <isSummary value="true"/>
          <mapping>
            <identity value="idmp-substance"/>
            <map value="n/a"/>
          </mapping>
        </element>
        <element id="SubstanceDefinition.name:sub.translation">
          <path value="SubstanceDefinition.name.translation"/>
          <short value="A translation for this name into another human language"/>
          <definition
                      value="A translation for this name into another human language."/>
          <min value="0"/>
          <max value="*"/>
          <base>
            <path value="SubstanceDefinition.name.translation"/>
            <min value="0"/>
            <max value="*"/>
          </base>
          <contentReference
                            value="http://hl7.org/fhir/StructureDefinition/SubstanceDefinition#SubstanceDefinition.name"/>
          <constraint>
            <key value="ele-1"/>
            <severity value="error"/>
            <human value="All FHIR elements must have a @value or children"/>
            <expression
                        value="hasValue() or (children().count() &gt; id.count())"/>
            <source value="http://hl7.org/fhir/StructureDefinition/Element"/>
          </constraint>
          <mustSupport value="false"/>
          <isModifier value="false"/>
          <isSummary value="true"/>
          <mapping>
            <identity value="idmp-substance"/>
            <map value="n/a"/>
          </mapping>
        </element>
        <element id="SubstanceDefinition.name:sub.official">
          <path value="SubstanceDefinition.name.official"/>
          <short value="Details of the official nature of this name"/>
          <definition value="Details of the official nature of this name."/>
          <min value="0"/>
          <max value="*"/>
          <base>
            <path value="SubstanceDefinition.name.official"/>
            <min value="0"/>
            <max value="*"/>
          </base>
          <type>
            <code value="BackboneElement"/>
          </type>
          <constraint>
            <key value="ele-1"/>
            <severity value="error"/>
            <human value="All FHIR elements must have a @value or children"/>
            <expression
                        value="hasValue() or (children().count() &gt; id.count())"/>
            <source value="http://hl7.org/fhir/StructureDefinition/Element"/>
          </constraint>
          <mustSupport value="false"/>
          <isModifier value="false"/>
          <isSummary value="true"/>
          <mapping>
            <identity value="idmp-substance"/>
            <map value="Substance_Name.Official_Name"/>
          </mapping>
        </element>
        <element id="SubstanceDefinition.name:sub.official.id">
          <path value="SubstanceDefinition.name.official.id"/>
          <representation value="xmlAttr"/>
          <short value="Unique id for inter-element referencing"/>
          <definition
                      value="Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces."/>
          <min value="0"/>
          <max value="1"/>
          <base>
            <path value="Element.id"/>
            <min value="0"/>
            <max value="1"/>
          </base>
          <type>
            <extension
                       url="http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type">
              <valueUrl value="string"/>
            </extension>
            <code value="http://hl7.org/fhirpath/System.String"/>
          </type>
          <condition value="ele-1"/>
          <isModifier value="false"/>
          <isSummary value="false"/>
          <mapping>
            <identity value="rim"/>
            <map value="n/a"/>
          </mapping>
        </element>
        <element id="SubstanceDefinition.name:sub.official.extension">
          <path value="SubstanceDefinition.name.official.extension"/>
          <short value="Additional content defined by implementations"/>
          <definition
                      value="May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension."/>
          <comment
                   value="There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions.  The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone."/>
          <alias value="extensions"/>
          <alias value="user content"/>
          <min value="0"/>
          <max value="*"/>
          <base>
            <path value="Element.extension"/>
            <min value="0"/>
            <max value="*"/>
          </base>
          <type>
            <code value="Extension"/>
          </type>
          <constraint>
            <key value="ele-1"/>
            <severity value="error"/>
            <human value="All FHIR elements must have a @value or children"/>
            <expression
                        value="hasValue() or (children().count() &gt; id.count())"/>
            <source value="http://hl7.org/fhir/StructureDefinition/Element"/>
          </constraint>
          <constraint>
            <key value="ext-1"/>
            <severity value="error"/>
            <human value="Must have either extensions or value[x], not both"/>
            <expression value="extension.exists() != value.exists()"/>
            <source value="http://hl7.org/fhir/StructureDefinition/Extension"/>
          </constraint>
          <isModifier value="false"/>
          <isSummary value="false"/>
          <mapping>
            <identity value="rim"/>
            <map value="n/a"/>
          </mapping>
        </element>
        <element id="SubstanceDefinition.name:sub.official.modifierExtension">
          <path value="SubstanceDefinition.name.official.modifierExtension"/>
          <short value="Extensions that cannot be ignored even if unrecognized"/>
          <definition
                      value="May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.

    Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself)."/>
          <comment
                   value="There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions.  The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone."/>
          <requirements
                        value="Modifier extensions allow for extensions that *cannot* be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored.  This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the [definition of modifier extensions](http://hl7.org/fhir/R5/extensibility.html#modifierExtension)."/>
          <alias value="extensions"/>
          <alias value="user content"/>
          <alias value="modifiers"/>
          <min value="0"/>
          <max value="*"/>
          <base>
            <path value="BackboneElement.modifierExtension"/>
            <min value="0"/>
            <max value="*"/>
          </base>
          <type>
            <code value="Extension"/>
          </type>
          <constraint>
            <key value="ele-1"/>
            <severity value="error"/>
            <human value="All FHIR elements must have a @value or children"/>
            <expression
                        value="hasValue() or (children().count() &gt; id.count())"/>
            <source value="http://hl7.org/fhir/StructureDefinition/Element"/>
          </constraint>
          <constraint>
            <key value="ext-1"/>
            <severity value="error"/>
            <human value="Must have either extensions or value[x], not both"/>
            <expression value="extension.exists() != value.exists()"/>
            <source value="http://hl7.org/fhir/StructureDefinition/Extension"/>
          </constraint>
          <isModifier value="true"/>
          <isModifierReason
                            value="Modifier extensions are expected to modify the meaning or interpretation of the element that contains them"/>
          <isSummary value="true"/>
          <mapping>
            <identity value="rim"/>
            <map value="N/A"/>
          </mapping>
        </element>
        <element id="SubstanceDefinition.name:sub.official.authority">
          <path value="SubstanceDefinition.name.official.authority"/>
          <short value="Which authority uses this official name"/>
          <definition value="Which authority uses this official name."/>
          <min value="0"/>
          <max value="1"/>
          <base>
            <path value="SubstanceDefinition.name.official.authority"/>
            <min value="0"/>
            <max value="1"/>
          </base>
          <type>
            <code value="CodeableConcept"/>
          </type>
          <constraint>
            <key value="ele-1"/>
            <severity value="error"/>
            <human value="All FHIR elements must have a @value or children"/>
            <expression
                        value="hasValue() or (children().count() &gt; id.count())"/>
            <source value="http://hl7.org/fhir/StructureDefinition/Element"/>
          </constraint>
          <mustSupport value="false"/>
          <isModifier value="false"/>
          <isSummary value="true"/>
          <binding>
            <extension
                       url="http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName">
              <valueString value="SubstanceNameAuthority"/>
            </extension>
            <strength value="preferred"/>
            <description value="An authority that officates substance names."/>
            <valueSet
                      value="http://hl7.org/fhir/ValueSet/substance-name-authority"/>
          </binding>
          <mapping>
            <identity value="idmp-substance"/>
            <map value="Official_Name.Official_Name_Type"/>
          </mapping>
        </element>
        <element id="SubstanceDefinition.name:sub.official.status">
          <path value="SubstanceDefinition.name.official.status"/>
          <short
                 value="The status of the official name, for example 'draft', 'active'"/>
          <definition
                      value="The status of the official name, for example 'draft', 'active', 'retired'."/>
          <min value="0"/>
          <max value="1"/>
          <base>
            <path value="SubstanceDefinition.name.official.status"/>
            <min value="0"/>
            <max value="1"/>
          </base>
          <type>
            <code value="CodeableConcept"/>
          </type>
          <constraint>
            <key value="ele-1"/>
            <severity value="error"/>
            <human value="All FHIR elements must have a @value or children"/>
            <expression
                        value="hasValue() or (children().count() &gt; id.count())"/>
            <source value="http://hl7.org/fhir/StructureDefinition/Element"/>
          </constraint>
          <mustSupport value="false"/>
          <isModifier value="false"/>
          <isSummary value="true"/>
          <binding>
            <extension
                       url="http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName">
              <valueString value="PublicationStatus"/>
            </extension>
            <strength value="preferred"/>
            <description value="The lifecycle status of an artifact."/>
            <valueSet value="http://hl7.org/fhir/ValueSet/publication-status"/>
          </binding>
          <mapping>
            <identity value="idmp-substance"/>
            <map value="Official_Name.Official_Name_Status"/>
          </mapping>
        </element>
        <element id="SubstanceDefinition.name:sub.official.date">
          <path value="SubstanceDefinition.name.official.date"/>
          <short value="Date of official name change"/>
          <definition value="Date of the official name change."/>
          <min value="0"/>
          <max value="1"/>
          <base>
            <path value="SubstanceDefinition.name.official.date"/>
            <min value="0"/>
            <max value="1"/>
          </base>
          <type>
            <code value="dateTime"/>
          </type>
          <constraint>
            <key value="ele-1"/>
            <severity value="error"/>
            <human value="All FHIR elements must have a @value or children"/>
            <expression
                        value="hasValue() or (children().count() &gt; id.count())"/>
            <source value="http://hl7.org/fhir/StructureDefinition/Element"/>
          </constraint>
          <mustSupport value="false"/>
          <isModifier value="false"/>
          <isSummary value="true"/>
          <mapping>
            <identity value="idmp-substance"/>
            <map value="Official_Name.Official_Name_Status_Change_Date"/>
          </mapping>
        </element>
        <element id="SubstanceDefinition.name:sub.source">
          <path value="SubstanceDefinition.name.source"/>
          <short value="Supporting literature"/>
          <definition value="Supporting literature."/>
          <min value="0"/>
          <max value="*"/>
          <base>
            <path value="SubstanceDefinition.name.source"/>
            <min value="0"/>
            <max value="*"/>
          </base>
          <type>
            <code value="Reference"/>
            <targetProfile
                           value="http://hl7.org/fhir/StructureDefinition/DocumentReference"/>
          </type>
          <constraint>
            <key value="ele-1"/>
            <severity value="error"/>
            <human value="All FHIR elements must have a @value or children"/>
            <expression
                        value="hasValue() or (children().count() &gt; id.count())"/>
            <source value="http://hl7.org/fhir/StructureDefinition/Element"/>
          </constraint>
          <mustSupport value="false"/>
          <isModifier value="false"/>
          <isSummary value="true"/>
          <mapping>
            <identity value="idmp-substance"/>
            <map value="Substance_Name.Reference_Source"/>
          </mapping>
        </element>
        <element id="SubstanceDefinition.name:gsrs">
          <path value="SubstanceDefinition.name"/>
          <sliceName value="gsrs"/>
          <short value="Names applicable to this substance"/>
          <definition value="Names applicable to this substance."/>
          <min value="0"/>
          <max value="1"/>
          <base>
            <path value="SubstanceDefinition.name"/>
            <min value="0"/>
            <max value="*"/>
          </base>
          <type>
            <code value="BackboneElement"/>
          </type>
          <constraint>
            <key value="ele-1"/>
            <severity value="error"/>
            <human value="All FHIR elements must have a @value or children"/>
            <expression
                        value="hasValue() or (children().count() &gt; id.count())"/>
            <source value="http://hl7.org/fhir/StructureDefinition/Element"/>
          </constraint>
          <mustSupport value="true"/>
          <isModifier value="false"/>
          <isSummary value="true"/>
          <mapping>
            <identity value="idmp-substance"/>
            <map value="Substance.Substance_Name"/>
          </mapping>
        </element>
        <element id="SubstanceDefinition.name:gsrs.id">
          <path value="SubstanceDefinition.name.id"/>
          <representation value="xmlAttr"/>
          <short value="Unique id for inter-element referencing"/>
          <definition
                      value="Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces."/>
          <min value="0"/>
          <max value="1"/>
          <base>
            <path value="Element.id"/>
            <min value="0"/>
            <max value="1"/>
          </base>
          <type>
            <extension
                       url="http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type">
              <valueUrl value="string"/>
            </extension>
            <code value="http://hl7.org/fhirpath/System.String"/>
          </type>
          <condition value="ele-1"/>
          <isModifier value="false"/>
          <isSummary value="false"/>
          <mapping>
            <identity value="rim"/>
            <map value="n/a"/>
          </mapping>
        </element>
        <element id="SubstanceDefinition.name:gsrs.extension">
          <path value="SubstanceDefinition.name.extension"/>
          <short value="Additional content defined by implementations"/>
          <definition
                      value="May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension."/>
          <comment
                   value="There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions.  The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone."/>
          <alias value="extensions"/>
          <alias value="user content"/>
          <min value="0"/>
          <max value="*"/>
          <base>
            <path value="Element.extension"/>
            <min value="0"/>
            <max value="*"/>
          </base>
          <type>
            <code value="Extension"/>
          </type>
          <constraint>
            <key value="ele-1"/>
            <severity value="error"/>
            <human value="All FHIR elements must have a @value or children"/>
            <expression
                        value="hasValue() or (children().count() &gt; id.count())"/>
            <source value="http://hl7.org/fhir/StructureDefinition/Element"/>
          </constraint>
          <constraint>
            <key value="ext-1"/>
            <severity value="error"/>
            <human value="Must have either extensions or value[x], not both"/>
            <expression value="extension.exists() != value.exists()"/>
            <source value="http://hl7.org/fhir/StructureDefinition/Extension"/>
          </constraint>
          <isModifier value="false"/>
          <isSummary value="false"/>
          <mapping>
            <identity value="rim"/>
            <map value="n/a"/>
          </mapping>
        </element>
        <element id="SubstanceDefinition.name:gsrs.modifierExtension">
          <path value="SubstanceDefinition.name.modifierExtension"/>
          <short value="Extensions that cannot be ignored even if unrecognized"/>
          <definition
                      value="May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.

    Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself)."/>
          <comment
                   value="There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions.  The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone."/>
          <requirements
                        value="Modifier extensions allow for extensions that *cannot* be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored.  This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the [definition of modifier extensions](http://hl7.org/fhir/R5/extensibility.html#modifierExtension)."/>
          <alias value="extensions"/>
          <alias value="user content"/>
          <alias value="modifiers"/>
          <min value="0"/>
          <max value="*"/>
          <base>
            <path value="BackboneElement.modifierExtension"/>
            <min value="0"/>
            <max value="*"/>
          </base>
          <type>
            <code value="Extension"/>
          </type>
          <constraint>
            <key value="ele-1"/>
            <severity value="error"/>
            <human value="All FHIR elements must have a @value or children"/>
            <expression
                        value="hasValue() or (children().count() &gt; id.count())"/>
            <source value="http://hl7.org/fhir/StructureDefinition/Element"/>
          </constraint>
          <constraint>
            <key value="ext-1"/>
            <severity value="error"/>
            <human value="Must have either extensions or value[x], not both"/>
            <expression value="extension.exists() != value.exists()"/>
            <source value="http://hl7.org/fhir/StructureDefinition/Extension"/>
          </constraint>
          <isModifier value="true"/>
          <isModifierReason
                            value="Modifier extensions are expected to modify the meaning or interpretation of the element that contains them"/>
          <isSummary value="true"/>
          <mapping>
            <identity value="rim"/>
            <map value="N/A"/>
          </mapping>
        </element>
        <element id="SubstanceDefinition.name:gsrs.name">
          <path value="SubstanceDefinition.name.name"/>
          <short value="GSRS Preferred Term"/>
          <definition
                      value="Default display name identified within FDA Global Substance Registration System (GSRS)."/>
          <min value="1"/>
          <max value="1"/>
          <base>
            <path value="SubstanceDefinition.name.name"/>
            <min value="1"/>
            <max value="1"/>
          </base>
          <type>
            <code value="string"/>
          </type>
          <constraint>
            <key value="ele-1"/>
            <severity value="error"/>
            <human value="All FHIR elements must have a @value or children"/>
            <expression
                        value="hasValue() or (children().count() &gt; id.count())"/>
            <source value="http://hl7.org/fhir/StructureDefinition/Element"/>
          </constraint>
          <mustSupport value="true"/>
          <isModifier value="false"/>
          <isSummary value="true"/>
          <mapping>
            <identity value="idmp-substance"/>
            <map value="Substance_Name.Substance_Name"/>
          </mapping>
        </element>
        <element id="SubstanceDefinition.name:gsrs.type">
          <path value="SubstanceDefinition.name.type"/>
          <short value="Name type e.g. 'systematic',  'scientific, 'brand'"/>
          <definition
                      value="Name type, for example 'systematic',  'scientific, 'brand'."/>
          <min value="1"/>
          <max value="1"/>
          <base>
            <path value="SubstanceDefinition.name.type"/>
            <min value="0"/>
            <max value="1"/>
          </base>
          <type>
            <code value="CodeableConcept"/>
          </type>
          <patternCodeableConcept>
            <coding>
              <system value="http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl"/>
              <code value="C203355"/>
              <display value="GSRS Preferred Term"/>
            </coding>
          </patternCodeableConcept>
          <constraint>
            <key value="ele-1"/>
            <severity value="error"/>
            <human value="All FHIR elements must have a @value or children"/>
            <expression
                        value="hasValue() or (children().count() &gt; id.count())"/>
            <source value="http://hl7.org/fhir/StructureDefinition/Element"/>
          </constraint>
          <mustSupport value="true"/>
          <isModifier value="false"/>
          <isSummary value="true"/>
          <binding>
            <strength value="required"/>
            <valueSet
                      value="http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-substance-name-type"/>
          </binding>
          <mapping>
            <identity value="idmp-substance"/>
            <map value="Substance_Name.Substance_Name_Type"/>
          </mapping>
        </element>
        <element id="SubstanceDefinition.name:gsrs.status">
          <path value="SubstanceDefinition.name.status"/>
          <short value="The status of the name e.g. 'current', 'proposed'"/>
          <definition
                      value="The status of the name, for example 'current', 'proposed'."/>
          <min value="0"/>
          <max value="1"/>
          <base>
            <path value="SubstanceDefinition.name.status"/>
            <min value="0"/>
            <max value="1"/>
          </base>
          <type>
            <code value="CodeableConcept"/>
          </type>
          <constraint>
            <key value="ele-1"/>
            <severity value="error"/>
            <human value="All FHIR elements must have a @value or children"/>
            <expression
                        value="hasValue() or (children().count() &gt; id.count())"/>
            <source value="http://hl7.org/fhir/StructureDefinition/Element"/>
          </constraint>
          <mustSupport value="false"/>
          <isModifier value="false"/>
          <isSummary value="true"/>
          <binding>
            <extension
                       url="http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName">
              <valueString value="PublicationStatus"/>
            </extension>
            <strength value="preferred"/>
            <description value="The lifecycle status of an artifact."/>
            <valueSet value="http://hl7.org/fhir/ValueSet/publication-status"/>
          </binding>
          <mapping>
            <identity value="idmp-substance"/>
            <map value="n/a"/>
          </mapping>
        </element>
        <element id="SubstanceDefinition.name:gsrs.preferred">
          <path value="SubstanceDefinition.name.preferred"/>
          <short value="True when the name type is Substance Name"/>
          <definition value="If this is the preferred name for this substance."/>
          <min value="0"/>
          <max value="1"/>
          <base>
            <path value="SubstanceDefinition.name.preferred"/>
            <min value="0"/>
            <max value="1"/>
          </base>
          <type>
            <code value="boolean"/>
          </type>
          <meaningWhenMissing
                              value="If this value is not present, there is no statement being made about whether this is the preferred name or not. No inference can be made"/>
          <constraint>
            <key value="ele-1"/>
            <severity value="error"/>
            <human value="All FHIR elements must have a @value or children"/>
            <expression
                        value="hasValue() or (children().count() &gt; id.count())"/>
            <source value="http://hl7.org/fhir/StructureDefinition/Element"/>
          </constraint>
          <mustSupport value="true"/>
          <isModifier value="false"/>
          <isSummary value="true"/>
          <mapping>
            <identity value="idmp-substance"/>
            <map value="n/a"/>
          </mapping>
        </element>
        <element id="SubstanceDefinition.name:gsrs.language">
          <path value="SubstanceDefinition.name.language"/>
          <short value="Human language that the name is written in"/>
          <definition value="Human language that the name is written in."/>
          <min value="0"/>
          <max value="*"/>
          <base>
            <path value="SubstanceDefinition.name.language"/>
            <min value="0"/>
            <max value="*"/>
          </base>
          <type>
            <code value="CodeableConcept"/>
          </type>
          <constraint>
            <key value="ele-1"/>
            <severity value="error"/>
            <human value="All FHIR elements must have a @value or children"/>
            <expression
                        value="hasValue() or (children().count() &gt; id.count())"/>
            <source value="http://hl7.org/fhir/StructureDefinition/Element"/>
          </constraint>
          <mustSupport value="false"/>
          <isModifier value="false"/>
          <isSummary value="true"/>
          <binding>
            <extension
                       url="http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName">
              <valueString value="Language"/>
            </extension>
            <strength value="required"/>
            <description value="IETF language tag for a human language"/>
            <valueSet value="http://hl7.org/fhir/ValueSet/all-languages|5.0.0"/>
            <additional>
              <purpose value="starter"/>
              <valueSet value="http://hl7.org/fhir/ValueSet/languages"/>
            </additional>
          </binding>
          <mapping>
            <identity value="idmp-substance"/>
            <map value="Substance_Name.Language"/>
          </mapping>
        </element>
        <element id="SubstanceDefinition.name:gsrs.domain">
          <path value="SubstanceDefinition.name.domain"/>
          <short
                 value="The use context of this name e.g. as an active ingredient or as a food colour additive"/>
          <definition
                      value="The use context of this name for example if there is a different name a drug active ingredient as opposed to a food colour additive."/>
          <min value="0"/>
          <max value="*"/>
          <base>
            <path value="SubstanceDefinition.name.domain"/>
            <min value="0"/>
            <max value="*"/>
          </base>
          <type>
            <code value="CodeableConcept"/>
          </type>
          <constraint>
            <key value="ele-1"/>
            <severity value="error"/>
            <human value="All FHIR elements must have a @value or children"/>
            <expression
                        value="hasValue() or (children().count() &gt; id.count())"/>
            <source value="http://hl7.org/fhir/StructureDefinition/Element"/>
          </constraint>
          <mustSupport value="false"/>
          <isModifier value="false"/>
          <isSummary value="true"/>
          <binding>
            <extension
                       url="http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName">
              <valueString value="SubstanceNameDomain"/>
            </extension>
            <strength value="example"/>
            <description
                         value="The use context of a substance name for example if there is a different name when used as a drug active ingredient as opposed to a food colour additive."/>
            <valueSet value="http://hl7.org/fhir/ValueSet/substance-name-domain"/>
          </binding>
          <mapping>
            <identity value="idmp-substance"/>
            <map value="Substance_Name.Substance_Name_Domain"/>
          </mapping>
        </element>
        <element id="SubstanceDefinition.name:gsrs.jurisdiction">
          <path value="SubstanceDefinition.name.jurisdiction"/>
          <short value="The jurisdiction where this name applies"/>
          <definition value="The jurisdiction where this name applies."/>
          <min value="0"/>
          <max value="*"/>
          <base>
            <path value="SubstanceDefinition.name.jurisdiction"/>
            <min value="0"/>
            <max value="*"/>
          </base>
          <type>
            <code value="CodeableConcept"/>
          </type>
          <constraint>
            <key value="ele-1"/>
            <severity value="error"/>
            <human value="All FHIR elements must have a @value or children"/>
            <expression
                        value="hasValue() or (children().count() &gt; id.count())"/>
            <source value="http://hl7.org/fhir/StructureDefinition/Element"/>
          </constraint>
          <mustSupport value="false"/>
          <isModifier value="false"/>
          <isSummary value="true"/>
          <binding>
            <extension
                       url="http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName">
              <valueString value="Jurisdiction"/>
            </extension>
            <strength value="example"/>
            <description value="Jurisdiction codes"/>
            <valueSet value="http://hl7.org/fhir/ValueSet/jurisdiction"/>
          </binding>
          <mapping>
            <identity value="idmp-substance"/>
            <map value="Substance_Name.Jurisdiction"/>
          </mapping>
        </element>
        <element id="SubstanceDefinition.name:gsrs.synonym">
          <path value="SubstanceDefinition.name.synonym"/>
          <short
                 value="A synonym of this particular name, by which the substance is also known"/>
          <definition
                      value="A synonym of this particular name, by which the substance is also known."/>
          <min value="0"/>
          <max value="*"/>
          <base>
            <path value="SubstanceDefinition.name.synonym"/>
            <min value="0"/>
            <max value="*"/>
          </base>
          <contentReference
                            value="http://hl7.org/fhir/StructureDefinition/SubstanceDefinition#SubstanceDefinition.name"/>
          <constraint>
            <key value="ele-1"/>
            <severity value="error"/>
            <human value="All FHIR elements must have a @value or children"/>
            <expression
                        value="hasValue() or (children().count() &gt; id.count())"/>
            <source value="http://hl7.org/fhir/StructureDefinition/Element"/>
          </constraint>
          <mustSupport value="false"/>
          <isModifier value="false"/>
          <isSummary value="true"/>
          <mapping>
            <identity value="idmp-substance"/>
            <map value="n/a"/>
          </mapping>
        </element>
        <element id="SubstanceDefinition.name:gsrs.translation">
          <path value="SubstanceDefinition.name.translation"/>
          <short value="A translation for this name into another human language"/>
          <definition
                      value="A translation for this name into another human language."/>
          <min value="0"/>
          <max value="*"/>
          <base>
            <path value="SubstanceDefinition.name.translation"/>
            <min value="0"/>
            <max value="*"/>
          </base>
          <contentReference
                            value="http://hl7.org/fhir/StructureDefinition/SubstanceDefinition#SubstanceDefinition.name"/>
          <constraint>
            <key value="ele-1"/>
            <severity value="error"/>
            <human value="All FHIR elements must have a @value or children"/>
            <expression
                        value="hasValue() or (children().count() &gt; id.count())"/>
            <source value="http://hl7.org/fhir/StructureDefinition/Element"/>
          </constraint>
          <mustSupport value="false"/>
          <isModifier value="false"/>
          <isSummary value="true"/>
          <mapping>
            <identity value="idmp-substance"/>
            <map value="n/a"/>
          </mapping>
        </element>
        <element id="SubstanceDefinition.name:gsrs.official">
          <path value="SubstanceDefinition.name.official"/>
          <short value="Details of the official nature of this name"/>
          <definition value="Details of the official nature of this name."/>
          <min value="0"/>
          <max value="*"/>
          <base>
            <path value="SubstanceDefinition.name.official"/>
            <min value="0"/>
            <max value="*"/>
          </base>
          <type>
            <code value="BackboneElement"/>
          </type>
          <constraint>
            <key value="ele-1"/>
            <severity value="error"/>
            <human value="All FHIR elements must have a @value or children"/>
            <expression
                        value="hasValue() or (children().count() &gt; id.count())"/>
            <source value="http://hl7.org/fhir/StructureDefinition/Element"/>
          </constraint>
          <mustSupport value="false"/>
          <isModifier value="false"/>
          <isSummary value="true"/>
          <mapping>
            <identity value="idmp-substance"/>
            <map value="Substance_Name.Official_Name"/>
          </mapping>
        </element>
        <element id="SubstanceDefinition.name:gsrs.official.id">
          <path value="SubstanceDefinition.name.official.id"/>
          <representation value="xmlAttr"/>
          <short value="Unique id for inter-element referencing"/>
          <definition
                      value="Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces."/>
          <min value="0"/>
          <max value="1"/>
          <base>
            <path value="Element.id"/>
            <min value="0"/>
            <max value="1"/>
          </base>
          <type>
            <extension
                       url="http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type">
              <valueUrl value="string"/>
            </extension>
            <code value="http://hl7.org/fhirpath/System.String"/>
          </type>
          <condition value="ele-1"/>
          <isModifier value="false"/>
          <isSummary value="false"/>
          <mapping>
            <identity value="rim"/>
            <map value="n/a"/>
          </mapping>
        </element>
        <element id="SubstanceDefinition.name:gsrs.official.extension">
          <path value="SubstanceDefinition.name.official.extension"/>
          <short value="Additional content defined by implementations"/>
          <definition
                      value="May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension."/>
          <comment
                   value="There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions.  The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone."/>
          <alias value="extensions"/>
          <alias value="user content"/>
          <min value="0"/>
          <max value="*"/>
          <base>
            <path value="Element.extension"/>
            <min value="0"/>
            <max value="*"/>
          </base>
          <type>
            <code value="Extension"/>
          </type>
          <constraint>
            <key value="ele-1"/>
            <severity value="error"/>
            <human value="All FHIR elements must have a @value or children"/>
            <expression
                        value="hasValue() or (children().count() &gt; id.count())"/>
            <source value="http://hl7.org/fhir/StructureDefinition/Element"/>
          </constraint>
          <constraint>
            <key value="ext-1"/>
            <severity value="error"/>
            <human value="Must have either extensions or value[x], not both"/>
            <expression value="extension.exists() != value.exists()"/>
            <source value="http://hl7.org/fhir/StructureDefinition/Extension"/>
          </constraint>
          <isModifier value="false"/>
          <isSummary value="false"/>
          <mapping>
            <identity value="rim"/>
            <map value="n/a"/>
          </mapping>
        </element>
        <element id="SubstanceDefinition.name:gsrs.official.modifierExtension">
          <path value="SubstanceDefinition.name.official.modifierExtension"/>
          <short value="Extensions that cannot be ignored even if unrecognized"/>
          <definition
                      value="May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.

    Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself)."/>
          <comment
                   value="There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions.  The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone."/>
          <requirements
                        value="Modifier extensions allow for extensions that *cannot* be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored.  This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the [definition of modifier extensions](http://hl7.org/fhir/R5/extensibility.html#modifierExtension)."/>
          <alias value="extensions"/>
          <alias value="user content"/>
          <alias value="modifiers"/>
          <min value="0"/>
          <max value="*"/>
          <base>
            <path value="BackboneElement.modifierExtension"/>
            <min value="0"/>
            <max value="*"/>
          </base>
          <type>
            <code value="Extension"/>
          </type>
          <constraint>
            <key value="ele-1"/>
            <severity value="error"/>
            <human value="All FHIR elements must have a @value or children"/>
            <expression
                        value="hasValue() or (children().count() &gt; id.count())"/>
            <source value="http://hl7.org/fhir/StructureDefinition/Element"/>
          </constraint>
          <constraint>
            <key value="ext-1"/>
            <severity value="error"/>
            <human value="Must have either extensions or value[x], not both"/>
            <expression value="extension.exists() != value.exists()"/>
            <source value="http://hl7.org/fhir/StructureDefinition/Extension"/>
          </constraint>
          <isModifier value="true"/>
          <isModifierReason
                            value="Modifier extensions are expected to modify the meaning or interpretation of the element that contains them"/>
          <isSummary value="true"/>
          <mapping>
            <identity value="rim"/>
            <map value="N/A"/>
          </mapping>
        </element>
        <element id="SubstanceDefinition.name:gsrs.official.authority">
          <path value="SubstanceDefinition.name.official.authority"/>
          <short value="Which authority uses this official name"/>
          <definition value="Which authority uses this official name."/>
          <min value="0"/>
          <max value="1"/>
          <base>
            <path value="SubstanceDefinition.name.official.authority"/>
            <min value="0"/>
            <max value="1"/>
          </base>
          <type>
            <code value="CodeableConcept"/>
          </type>
          <constraint>
            <key value="ele-1"/>
            <severity value="error"/>
            <human value="All FHIR elements must have a @value or children"/>
            <expression
                        value="hasValue() or (children().count() &gt; id.count())"/>
            <source value="http://hl7.org/fhir/StructureDefinition/Element"/>
          </constraint>
          <mustSupport value="false"/>
          <isModifier value="false"/>
          <isSummary value="true"/>
          <binding>
            <extension
                       url="http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName">
              <valueString value="SubstanceNameAuthority"/>
            </extension>
            <strength value="preferred"/>
            <description value="An authority that officates substance names."/>
            <valueSet
                      value="http://hl7.org/fhir/ValueSet/substance-name-authority"/>
          </binding>
          <mapping>
            <identity value="idmp-substance"/>
            <map value="Official_Name.Official_Name_Type"/>
          </mapping>
        </element>
        <element id="SubstanceDefinition.name:gsrs.official.status">
          <path value="SubstanceDefinition.name.official.status"/>
          <short
                 value="The status of the official name, for example 'draft', 'active'"/>
          <definition
                      value="The status of the official name, for example 'draft', 'active', 'retired'."/>
          <min value="0"/>
          <max value="1"/>
          <base>
            <path value="SubstanceDefinition.name.official.status"/>
            <min value="0"/>
            <max value="1"/>
          </base>
          <type>
            <code value="CodeableConcept"/>
          </type>
          <constraint>
            <key value="ele-1"/>
            <severity value="error"/>
            <human value="All FHIR elements must have a @value or children"/>
            <expression
                        value="hasValue() or (children().count() &gt; id.count())"/>
            <source value="http://hl7.org/fhir/StructureDefinition/Element"/>
          </constraint>
          <mustSupport value="false"/>
          <isModifier value="false"/>
          <isSummary value="true"/>
          <binding>
            <extension
                       url="http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName">
              <valueString value="PublicationStatus"/>
            </extension>
            <strength value="preferred"/>
            <description value="The lifecycle status of an artifact."/>
            <valueSet value="http://hl7.org/fhir/ValueSet/publication-status"/>
          </binding>
          <mapping>
            <identity value="idmp-substance"/>
            <map value="Official_Name.Official_Name_Status"/>
          </mapping>
        </element>
        <element id="SubstanceDefinition.name:gsrs.official.date">
          <path value="SubstanceDefinition.name.official.date"/>
          <short value="Date of official name change"/>
          <definition value="Date of the official name change."/>
          <min value="0"/>
          <max value="1"/>
          <base>
            <path value="SubstanceDefinition.name.official.date"/>
            <min value="0"/>
            <max value="1"/>
          </base>
          <type>
            <code value="dateTime"/>
          </type>
          <constraint>
            <key value="ele-1"/>
            <severity value="error"/>
            <human value="All FHIR elements must have a @value or children"/>
            <expression
                        value="hasValue() or (children().count() &gt; id.count())"/>
            <source value="http://hl7.org/fhir/StructureDefinition/Element"/>
          </constraint>
          <mustSupport value="false"/>
          <isModifier value="false"/>
          <isSummary value="true"/>
          <mapping>
            <identity value="idmp-substance"/>
            <map value="Official_Name.Official_Name_Status_Change_Date"/>
          </mapping>
        </element>
        <element id="SubstanceDefinition.name:gsrs.source">
          <path value="SubstanceDefinition.name.source"/>
          <short value="Supporting literature"/>
          <definition value="Supporting literature."/>
          <min value="0"/>
          <max value="*"/>
          <base>
            <path value="SubstanceDefinition.name.source"/>
            <min value="0"/>
            <max value="*"/>
          </base>
          <type>
            <code value="Reference"/>
            <targetProfile
                           value="http://hl7.org/fhir/StructureDefinition/DocumentReference"/>
          </type>
          <constraint>
            <key value="ele-1"/>
            <severity value="error"/>
            <human value="All FHIR elements must have a @value or children"/>
            <expression
                        value="hasValue() or (children().count() &gt; id.count())"/>
            <source value="http://hl7.org/fhir/StructureDefinition/Element"/>
          </constraint>
          <mustSupport value="false"/>
          <isModifier value="false"/>
          <isSummary value="true"/>
          <mapping>
            <identity value="idmp-substance"/>
            <map value="Substance_Name.Reference_Source"/>
          </mapping>
        </element>
        <element id="SubstanceDefinition.name:isbt">
          <path value="SubstanceDefinition.name"/>
          <sliceName value="isbt"/>
          <short value="Names applicable to this substance"/>
          <definition value="Names applicable to this substance."/>
          <min value="0"/>
          <max value="1"/>
          <base>
            <path value="SubstanceDefinition.name"/>
            <min value="0"/>
            <max value="*"/>
          </base>
          <type>
            <code value="BackboneElement"/>
          </type>
          <constraint>
            <key value="ele-1"/>
            <severity value="error"/>
            <human value="All FHIR elements must have a @value or children"/>
            <expression
                        value="hasValue() or (children().count() &gt; id.count())"/>
            <source value="http://hl7.org/fhir/StructureDefinition/Element"/>
          </constraint>
          <mustSupport value="true"/>
          <isModifier value="false"/>
          <isSummary value="true"/>
          <mapping>
            <identity value="idmp-substance"/>
            <map value="Substance.Substance_Name"/>
          </mapping>
        </element>
        <element id="SubstanceDefinition.name:isbt.id">
          <path value="SubstanceDefinition.name.id"/>
          <representation value="xmlAttr"/>
          <short value="Unique id for inter-element referencing"/>
          <definition
                      value="Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces."/>
          <min value="0"/>
          <max value="1"/>
          <base>
            <path value="Element.id"/>
            <min value="0"/>
            <max value="1"/>
          </base>
          <type>
            <extension
                       url="http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type">
              <valueUrl value="string"/>
            </extension>
            <code value="http://hl7.org/fhirpath/System.String"/>
          </type>
          <condition value="ele-1"/>
          <isModifier value="false"/>
          <isSummary value="false"/>
          <mapping>
            <identity value="rim"/>
            <map value="n/a"/>
          </mapping>
        </element>
        <element id="SubstanceDefinition.name:isbt.extension">
          <path value="SubstanceDefinition.name.extension"/>
          <short value="Additional content defined by implementations"/>
          <definition
                      value="May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension."/>
          <comment
                   value="There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions.  The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone."/>
          <alias value="extensions"/>
          <alias value="user content"/>
          <min value="0"/>
          <max value="*"/>
          <base>
            <path value="Element.extension"/>
            <min value="0"/>
            <max value="*"/>
          </base>
          <type>
            <code value="Extension"/>
          </type>
          <constraint>
            <key value="ele-1"/>
            <severity value="error"/>
            <human value="All FHIR elements must have a @value or children"/>
            <expression
                        value="hasValue() or (children().count() &gt; id.count())"/>
            <source value="http://hl7.org/fhir/StructureDefinition/Element"/>
          </constraint>
          <constraint>
            <key value="ext-1"/>
            <severity value="error"/>
            <human value="Must have either extensions or value[x], not both"/>
            <expression value="extension.exists() != value.exists()"/>
            <source value="http://hl7.org/fhir/StructureDefinition/Extension"/>
          </constraint>
          <isModifier value="false"/>
          <isSummary value="false"/>
          <mapping>
            <identity value="rim"/>
            <map value="n/a"/>
          </mapping>
        </element>
        <element id="SubstanceDefinition.name:isbt.modifierExtension">
          <path value="SubstanceDefinition.name.modifierExtension"/>
          <short value="Extensions that cannot be ignored even if unrecognized"/>
          <definition
                      value="May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.

    Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself)."/>
          <comment
                   value="There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions.  The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone."/>
          <requirements
                        value="Modifier extensions allow for extensions that *cannot* be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored.  This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the [definition of modifier extensions](http://hl7.org/fhir/R5/extensibility.html#modifierExtension)."/>
          <alias value="extensions"/>
          <alias value="user content"/>
          <alias value="modifiers"/>
          <min value="0"/>
          <max value="*"/>
          <base>
            <path value="BackboneElement.modifierExtension"/>
            <min value="0"/>
            <max value="*"/>
          </base>
          <type>
            <code value="Extension"/>
          </type>
          <constraint>
            <key value="ele-1"/>
            <severity value="error"/>
            <human value="All FHIR elements must have a @value or children"/>
            <expression
                        value="hasValue() or (children().count() &gt; id.count())"/>
            <source value="http://hl7.org/fhir/StructureDefinition/Element"/>
          </constraint>
          <constraint>
            <key value="ext-1"/>
            <severity value="error"/>
            <human value="Must have either extensions or value[x], not both"/>
            <expression value="extension.exists() != value.exists()"/>
            <source value="http://hl7.org/fhir/StructureDefinition/Extension"/>
          </constraint>
          <isModifier value="true"/>
          <isModifierReason
                            value="Modifier extensions are expected to modify the meaning or interpretation of the element that contains them"/>
          <isSummary value="true"/>
          <mapping>
            <identity value="rim"/>
            <map value="N/A"/>
          </mapping>
        </element>
        <element id="SubstanceDefinition.name:isbt.name">
          <path value="SubstanceDefinition.name.name"/>
          <short value="ISBT-128 DIN"/>
          <definition
                      value="It is the global standard for the terminology, identification, coding and labeling of medical products of human origin (including blood, cell, tissue, milk, and organ products). [Source: https://www.iccbba.org/]"/>
          <min value="1"/>
          <max value="1"/>
          <base>
            <path value="SubstanceDefinition.name.name"/>
            <min value="1"/>
            <max value="1"/>
          </base>
          <type>
            <code value="string"/>
          </type>
          <constraint>
            <key value="ele-1"/>
            <severity value="error"/>
            <human value="All FHIR elements must have a @value or children"/>
            <expression
                        value="hasValue() or (children().count() &gt; id.count())"/>
            <source value="http://hl7.org/fhir/StructureDefinition/Element"/>
          </constraint>
          <mustSupport value="true"/>
          <isModifier value="false"/>
          <isSummary value="true"/>
          <mapping>
            <identity value="idmp-substance"/>
            <map value="Substance_Name.Substance_Name"/>
          </mapping>
        </element>
        <element id="SubstanceDefinition.name:isbt.type">
          <path value="SubstanceDefinition.name.type"/>
          <short value="Name type e.g. 'systematic',  'scientific, 'brand'"/>
          <definition
                      value="Name type, for example 'systematic',  'scientific, 'brand'."/>
          <min value="1"/>
          <max value="1"/>
          <base>
            <path value="SubstanceDefinition.name.type"/>
            <min value="0"/>
            <max value="1"/>
          </base>
          <type>
            <code value="CodeableConcept"/>
          </type>
          <patternCodeableConcept>
            <coding>
              <system value="http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl"/>
              <code value="C95517"/>
              <display value="ISBT-128 DIN"/>
            </coding>
          </patternCodeableConcept>
          <constraint>
            <key value="ele-1"/>
            <severity value="error"/>
            <human value="All FHIR elements must have a @value or children"/>
            <expression
                        value="hasValue() or (children().count() &gt; id.count())"/>
            <source value="http://hl7.org/fhir/StructureDefinition/Element"/>
          </constraint>
          <mustSupport value="true"/>
          <isModifier value="false"/>
          <isSummary value="true"/>
          <binding>
            <strength value="required"/>
            <valueSet
                      value="http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-substance-name-type"/>
          </binding>
          <mapping>
            <identity value="idmp-substance"/>
            <map value="Substance_Name.Substance_Name_Type"/>
          </mapping>
        </element>
        <element id="SubstanceDefinition.name:isbt.status">
          <path value="SubstanceDefinition.name.status"/>
          <short value="The status of the name e.g. 'current', 'proposed'"/>
          <definition
                      value="The status of the name, for example 'current', 'proposed'."/>
          <min value="0"/>
          <max value="1"/>
          <base>
            <path value="SubstanceDefinition.name.status"/>
            <min value="0"/>
            <max value="1"/>
          </base>
          <type>
            <code value="CodeableConcept"/>
          </type>
          <constraint>
            <key value="ele-1"/>
            <severity value="error"/>
            <human value="All FHIR elements must have a @value or children"/>
            <expression
                        value="hasValue() or (children().count() &gt; id.count())"/>
            <source value="http://hl7.org/fhir/StructureDefinition/Element"/>
          </constraint>
          <mustSupport value="false"/>
          <isModifier value="false"/>
          <isSummary value="true"/>
          <binding>
            <extension
                       url="http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName">
              <valueString value="PublicationStatus"/>
            </extension>
            <strength value="preferred"/>
            <description value="The lifecycle status of an artifact."/>
            <valueSet value="http://hl7.org/fhir/ValueSet/publication-status"/>
          </binding>
          <mapping>
            <identity value="idmp-substance"/>
            <map value="n/a"/>
          </mapping>
        </element>
        <element id="SubstanceDefinition.name:isbt.preferred">
          <path value="SubstanceDefinition.name.preferred"/>
          <short value="True when the name type is Substance Name"/>
          <definition value="If this is the preferred name for this substance."/>
          <min value="0"/>
          <max value="1"/>
          <base>
            <path value="SubstanceDefinition.name.preferred"/>
            <min value="0"/>
            <max value="1"/>
          </base>
          <type>
            <code value="boolean"/>
          </type>
          <meaningWhenMissing
                              value="If this value is not present, there is no statement being made about whether this is the preferred name or not. No inference can be made"/>
          <constraint>
            <key value="ele-1"/>
            <severity value="error"/>
            <human value="All FHIR elements must have a @value or children"/>
            <expression
                        value="hasValue() or (children().count() &gt; id.count())"/>
            <source value="http://hl7.org/fhir/StructureDefinition/Element"/>
          </constraint>
          <mustSupport value="true"/>
          <isModifier value="false"/>
          <isSummary value="true"/>
          <mapping>
            <identity value="idmp-substance"/>
            <map value="n/a"/>
          </mapping>
        </element>
        <element id="SubstanceDefinition.name:isbt.language">
          <path value="SubstanceDefinition.name.language"/>
          <short value="Human language that the name is written in"/>
          <definition value="Human language that the name is written in."/>
          <min value="0"/>
          <max value="*"/>
          <base>
            <path value="SubstanceDefinition.name.language"/>
            <min value="0"/>
            <max value="*"/>
          </base>
          <type>
            <code value="CodeableConcept"/>
          </type>
          <constraint>
            <key value="ele-1"/>
            <severity value="error"/>
            <human value="All FHIR elements must have a @value or children"/>
            <expression
                        value="hasValue() or (children().count() &gt; id.count())"/>
            <source value="http://hl7.org/fhir/StructureDefinition/Element"/>
          </constraint>
          <mustSupport value="false"/>
          <isModifier value="false"/>
          <isSummary value="true"/>
          <binding>
            <extension
                       url="http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName">
              <valueString value="Language"/>
            </extension>
            <strength value="required"/>
            <description value="IETF language tag for a human language"/>
            <valueSet value="http://hl7.org/fhir/ValueSet/all-languages|5.0.0"/>
            <additional>
              <purpose value="starter"/>
              <valueSet value="http://hl7.org/fhir/ValueSet/languages"/>
            </additional>
          </binding>
          <mapping>
            <identity value="idmp-substance"/>
            <map value="Substance_Name.Language"/>
          </mapping>
        </element>
        <element id="SubstanceDefinition.name:isbt.domain">
          <path value="SubstanceDefinition.name.domain"/>
          <short
                 value="The use context of this name e.g. as an active ingredient or as a food colour additive"/>
          <definition
                      value="The use context of this name for example if there is a different name a drug active ingredient as opposed to a food colour additive."/>
          <min value="0"/>
          <max value="*"/>
          <base>
            <path value="SubstanceDefinition.name.domain"/>
            <min value="0"/>
            <max value="*"/>
          </base>
          <type>
            <code value="CodeableConcept"/>
          </type>
          <constraint>
            <key value="ele-1"/>
            <severity value="error"/>
            <human value="All FHIR elements must have a @value or children"/>
            <expression
                        value="hasValue() or (children().count() &gt; id.count())"/>
            <source value="http://hl7.org/fhir/StructureDefinition/Element"/>
          </constraint>
          <mustSupport value="false"/>
          <isModifier value="false"/>
          <isSummary value="true"/>
          <binding>
            <extension
                       url="http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName">
              <valueString value="SubstanceNameDomain"/>
            </extension>
            <strength value="example"/>
            <description
                         value="The use context of a substance name for example if there is a different name when used as a drug active ingredient as opposed to a food colour additive."/>
            <valueSet value="http://hl7.org/fhir/ValueSet/substance-name-domain"/>
          </binding>
          <mapping>
            <identity value="idmp-substance"/>
            <map value="Substance_Name.Substance_Name_Domain"/>
          </mapping>
        </element>
        <element id="SubstanceDefinition.name:isbt.jurisdiction">
          <path value="SubstanceDefinition.name.jurisdiction"/>
          <short value="The jurisdiction where this name applies"/>
          <definition value="The jurisdiction where this name applies."/>
          <min value="0"/>
          <max value="*"/>
          <base>
            <path value="SubstanceDefinition.name.jurisdiction"/>
            <min value="0"/>
            <max value="*"/>
          </base>
          <type>
            <code value="CodeableConcept"/>
          </type>
          <constraint>
            <key value="ele-1"/>
            <severity value="error"/>
            <human value="All FHIR elements must have a @value or children"/>
            <expression
                        value="hasValue() or (children().count() &gt; id.count())"/>
            <source value="http://hl7.org/fhir/StructureDefinition/Element"/>
          </constraint>
          <mustSupport value="false"/>
          <isModifier value="false"/>
          <isSummary value="true"/>
          <binding>
            <extension
                       url="http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName">
              <valueString value="Jurisdiction"/>
            </extension>
            <strength value="example"/>
            <description value="Jurisdiction codes"/>
            <valueSet value="http://hl7.org/fhir/ValueSet/jurisdiction"/>
          </binding>
          <mapping>
            <identity value="idmp-substance"/>
            <map value="Substance_Name.Jurisdiction"/>
          </mapping>
        </element>
        <element id="SubstanceDefinition.name:isbt.synonym">
          <path value="SubstanceDefinition.name.synonym"/>
          <short
                 value="A synonym of this particular name, by which the substance is also known"/>
          <definition
                      value="A synonym of this particular name, by which the substance is also known."/>
          <min value="0"/>
          <max value="*"/>
          <base>
            <path value="SubstanceDefinition.name.synonym"/>
            <min value="0"/>
            <max value="*"/>
          </base>
          <contentReference
                            value="http://hl7.org/fhir/StructureDefinition/SubstanceDefinition#SubstanceDefinition.name"/>
          <constraint>
            <key value="ele-1"/>
            <severity value="error"/>
            <human value="All FHIR elements must have a @value or children"/>
            <expression
                        value="hasValue() or (children().count() &gt; id.count())"/>
            <source value="http://hl7.org/fhir/StructureDefinition/Element"/>
          </constraint>
          <mustSupport value="false"/>
          <isModifier value="false"/>
          <isSummary value="true"/>
          <mapping>
            <identity value="idmp-substance"/>
            <map value="n/a"/>
          </mapping>
        </element>
        <element id="SubstanceDefinition.name:isbt.translation">
          <path value="SubstanceDefinition.name.translation"/>
          <short value="A translation for this name into another human language"/>
          <definition
                      value="A translation for this name into another human language."/>
          <min value="0"/>
          <max value="*"/>
          <base>
            <path value="SubstanceDefinition.name.translation"/>
            <min value="0"/>
            <max value="*"/>
          </base>
          <contentReference
                            value="http://hl7.org/fhir/StructureDefinition/SubstanceDefinition#SubstanceDefinition.name"/>
          <constraint>
            <key value="ele-1"/>
            <severity value="error"/>
            <human value="All FHIR elements must have a @value or children"/>
            <expression
                        value="hasValue() or (children().count() &gt; id.count())"/>
            <source value="http://hl7.org/fhir/StructureDefinition/Element"/>
          </constraint>
          <mustSupport value="false"/>
          <isModifier value="false"/>
          <isSummary value="true"/>
          <mapping>
            <identity value="idmp-substance"/>
            <map value="n/a"/>
          </mapping>
        </element>
        <element id="SubstanceDefinition.name:isbt.official">
          <path value="SubstanceDefinition.name.official"/>
          <short value="Details of the official nature of this name"/>
          <definition value="Details of the official nature of this name."/>
          <min value="0"/>
          <max value="*"/>
          <base>
            <path value="SubstanceDefinition.name.official"/>
            <min value="0"/>
            <max value="*"/>
          </base>
          <type>
            <code value="BackboneElement"/>
          </type>
          <constraint>
            <key value="ele-1"/>
            <severity value="error"/>
            <human value="All FHIR elements must have a @value or children"/>
            <expression
                        value="hasValue() or (children().count() &gt; id.count())"/>
            <source value="http://hl7.org/fhir/StructureDefinition/Element"/>
          </constraint>
          <mustSupport value="false"/>
          <isModifier value="false"/>
          <isSummary value="true"/>
          <mapping>
            <identity value="idmp-substance"/>
            <map value="Substance_Name.Official_Name"/>
          </mapping>
        </element>
        <element id="SubstanceDefinition.name:isbt.official.id">
          <path value="SubstanceDefinition.name.official.id"/>
          <representation value="xmlAttr"/>
          <short value="Unique id for inter-element referencing"/>
          <definition
                      value="Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces."/>
          <min value="0"/>
          <max value="1"/>
          <base>
            <path value="Element.id"/>
            <min value="0"/>
            <max value="1"/>
          </base>
          <type>
            <extension
                       url="http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type">
              <valueUrl value="string"/>
            </extension>
            <code value="http://hl7.org/fhirpath/System.String"/>
          </type>
          <condition value="ele-1"/>
          <isModifier value="false"/>
          <isSummary value="false"/>
          <mapping>
            <identity value="rim"/>
            <map value="n/a"/>
          </mapping>
        </element>
        <element id="SubstanceDefinition.name:isbt.official.extension">
          <path value="SubstanceDefinition.name.official.extension"/>
          <short value="Additional content defined by implementations"/>
          <definition
                      value="May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension."/>
          <comment
                   value="There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions.  The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone."/>
          <alias value="extensions"/>
          <alias value="user content"/>
          <min value="0"/>
          <max value="*"/>
          <base>
            <path value="Element.extension"/>
            <min value="0"/>
            <max value="*"/>
          </base>
          <type>
            <code value="Extension"/>
          </type>
          <constraint>
            <key value="ele-1"/>
            <severity value="error"/>
            <human value="All FHIR elements must have a @value or children"/>
            <expression
                        value="hasValue() or (children().count() &gt; id.count())"/>
            <source value="http://hl7.org/fhir/StructureDefinition/Element"/>
          </constraint>
          <constraint>
            <key value="ext-1"/>
            <severity value="error"/>
            <human value="Must have either extensions or value[x], not both"/>
            <expression value="extension.exists() != value.exists()"/>
            <source value="http://hl7.org/fhir/StructureDefinition/Extension"/>
          </constraint>
          <isModifier value="false"/>
          <isSummary value="false"/>
          <mapping>
            <identity value="rim"/>
            <map value="n/a"/>
          </mapping>
        </element>
        <element id="SubstanceDefinition.name:isbt.official.modifierExtension">
          <path value="SubstanceDefinition.name.official.modifierExtension"/>
          <short value="Extensions that cannot be ignored even if unrecognized"/>
          <definition
                      value="May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.

    Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself)."/>
          <comment
                   value="There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions.  The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone."/>
          <requirements
                        value="Modifier extensions allow for extensions that *cannot* be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored.  This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the [definition of modifier extensions](http://hl7.org/fhir/R5/extensibility.html#modifierExtension)."/>
          <alias value="extensions"/>
          <alias value="user content"/>
          <alias value="modifiers"/>
          <min value="0"/>
          <max value="*"/>
          <base>
            <path value="BackboneElement.modifierExtension"/>
            <min value="0"/>
            <max value="*"/>
          </base>
          <type>
            <code value="Extension"/>
          </type>
          <constraint>
            <key value="ele-1"/>
            <severity value="error"/>
            <human value="All FHIR elements must have a @value or children"/>
            <expression
                        value="hasValue() or (children().count() &gt; id.count())"/>
            <source value="http://hl7.org/fhir/StructureDefinition/Element"/>
          </constraint>
          <constraint>
            <key value="ext-1"/>
            <severity value="error"/>
            <human value="Must have either extensions or value[x], not both"/>
            <expression value="extension.exists() != value.exists()"/>
            <source value="http://hl7.org/fhir/StructureDefinition/Extension"/>
          </constraint>
          <isModifier value="true"/>
          <isModifierReason
                            value="Modifier extensions are expected to modify the meaning or interpretation of the element that contains them"/>
          <isSummary value="true"/>
          <mapping>
            <identity value="rim"/>
            <map value="N/A"/>
          </mapping>
        </element>
        <element id="SubstanceDefinition.name:isbt.official.authority">
          <path value="SubstanceDefinition.name.official.authority"/>
          <short value="Which authority uses this official name"/>
          <definition value="Which authority uses this official name."/>
          <min value="0"/>
          <max value="1"/>
          <base>
            <path value="SubstanceDefinition.name.official.authority"/>
            <min value="0"/>
            <max value="1"/>
          </base>
          <type>
            <code value="CodeableConcept"/>
          </type>
          <constraint>
            <key value="ele-1"/>
            <severity value="error"/>
            <human value="All FHIR elements must have a @value or children"/>
            <expression
                        value="hasValue() or (children().count() &gt; id.count())"/>
            <source value="http://hl7.org/fhir/StructureDefinition/Element"/>
          </constraint>
          <mustSupport value="false"/>
          <isModifier value="false"/>
          <isSummary value="true"/>
          <binding>
            <extension
                       url="http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName">
              <valueString value="SubstanceNameAuthority"/>
            </extension>
            <strength value="preferred"/>
            <description value="An authority that officates substance names."/>
            <valueSet
                      value="http://hl7.org/fhir/ValueSet/substance-name-authority"/>
          </binding>
          <mapping>
            <identity value="idmp-substance"/>
            <map value="Official_Name.Official_Name_Type"/>
          </mapping>
        </element>
        <element id="SubstanceDefinition.name:isbt.official.status">
          <path value="SubstanceDefinition.name.official.status"/>
          <short
                 value="The status of the official name, for example 'draft', 'active'"/>
          <definition
                      value="The status of the official name, for example 'draft', 'active', 'retired'."/>
          <min value="0"/>
          <max value="1"/>
          <base>
            <path value="SubstanceDefinition.name.official.status"/>
            <min value="0"/>
            <max value="1"/>
          </base>
          <type>
            <code value="CodeableConcept"/>
          </type>
          <constraint>
            <key value="ele-1"/>
            <severity value="error"/>
            <human value="All FHIR elements must have a @value or children"/>
            <expression
                        value="hasValue() or (children().count() &gt; id.count())"/>
            <source value="http://hl7.org/fhir/StructureDefinition/Element"/>
          </constraint>
          <mustSupport value="false"/>
          <isModifier value="false"/>
          <isSummary value="true"/>
          <binding>
            <extension
                       url="http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName">
              <valueString value="PublicationStatus"/>
            </extension>
            <strength value="preferred"/>
            <description value="The lifecycle status of an artifact."/>
            <valueSet value="http://hl7.org/fhir/ValueSet/publication-status"/>
          </binding>
          <mapping>
            <identity value="idmp-substance"/>
            <map value="Official_Name.Official_Name_Status"/>
          </mapping>
        </element>
        <element id="SubstanceDefinition.name:isbt.official.date">
          <path value="SubstanceDefinition.name.official.date"/>
          <short value="Date of official name change"/>
          <definition value="Date of the official name change."/>
          <min value="0"/>
          <max value="1"/>
          <base>
            <path value="SubstanceDefinition.name.official.date"/>
            <min value="0"/>
            <max value="1"/>
          </base>
          <type>
            <code value="dateTime"/>
          </type>
          <constraint>
            <key value="ele-1"/>
            <severity value="error"/>
            <human value="All FHIR elements must have a @value or children"/>
            <expression
                        value="hasValue() or (children().count() &gt; id.count())"/>
            <source value="http://hl7.org/fhir/StructureDefinition/Element"/>
          </constraint>
          <mustSupport value="false"/>
          <isModifier value="false"/>
          <isSummary value="true"/>
          <mapping>
            <identity value="idmp-substance"/>
            <map value="Official_Name.Official_Name_Status_Change_Date"/>
          </mapping>
        </element>
        <element id="SubstanceDefinition.name:isbt.source">
          <path value="SubstanceDefinition.name.source"/>
          <short value="Supporting literature"/>
          <definition value="Supporting literature."/>
          <min value="0"/>
          <max value="*"/>
          <base>
            <path value="SubstanceDefinition.name.source"/>
            <min value="0"/>
            <max value="*"/>
          </base>
          <type>
            <code value="Reference"/>
            <targetProfile
                           value="http://hl7.org/fhir/StructureDefinition/DocumentReference"/>
          </type>
          <constraint>
            <key value="ele-1"/>
            <severity value="error"/>
            <human value="All FHIR elements must have a @value or children"/>
            <expression
                        value="hasValue() or (children().count() &gt; id.count())"/>
            <source value="http://hl7.org/fhir/StructureDefinition/Element"/>
          </constraint>
          <mustSupport value="false"/>
          <isModifier value="false"/>
          <isSummary value="true"/>
          <mapping>
            <identity value="idmp-substance"/>
            <map value="Substance_Name.Reference_Source"/>
          </mapping>
        </element>
        <element id="SubstanceDefinition.relationship">
          <path value="SubstanceDefinition.relationship"/>
          <short value="A link between this substance and another"/>
          <definition
                      value="A link between this substance and another, with details of the relationship."/>
          <min value="0"/>
          <max value="*"/>
          <base>
            <path value="SubstanceDefinition.relationship"/>
            <min value="0"/>
            <max value="*"/>
          </base>
          <type>
            <code value="BackboneElement"/>
          </type>
          <constraint>
            <key value="ele-1"/>
            <severity value="error"/>
            <human value="All FHIR elements must have a @value or children"/>
            <expression
                        value="hasValue() or (children().count() &gt; id.count())"/>
            <source value="http://hl7.org/fhir/StructureDefinition/Element"/>
          </constraint>
          <mustSupport value="false"/>
          <isModifier value="false"/>
          <isSummary value="true"/>
          <mapping>
            <identity value="idmp-substance"/>
            <map value="Substance.Reference_Information.Relationship"/>
          </mapping>
        </element>
        <element id="SubstanceDefinition.relationship.id">
          <path value="SubstanceDefinition.relationship.id"/>
          <representation value="xmlAttr"/>
          <short value="Unique id for inter-element referencing"/>
          <definition
                      value="Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces."/>
          <min value="0"/>
          <max value="1"/>
          <base>
            <path value="Element.id"/>
            <min value="0"/>
            <max value="1"/>
          </base>
          <type>
            <extension
                       url="http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type">
              <valueUrl value="string"/>
            </extension>
            <code value="http://hl7.org/fhirpath/System.String"/>
          </type>
          <condition value="ele-1"/>
          <isModifier value="false"/>
          <isSummary value="false"/>
          <mapping>
            <identity value="rim"/>
            <map value="n/a"/>
          </mapping>
        </element>
        <element id="SubstanceDefinition.relationship.extension">
          <path value="SubstanceDefinition.relationship.extension"/>
          <short value="Additional content defined by implementations"/>
          <definition
                      value="May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension."/>
          <comment
                   value="There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions.  The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone."/>
          <alias value="extensions"/>
          <alias value="user content"/>
          <min value="0"/>
          <max value="*"/>
          <base>
            <path value="Element.extension"/>
            <min value="0"/>
            <max value="*"/>
          </base>
          <type>
            <code value="Extension"/>
          </type>
          <constraint>
            <key value="ele-1"/>
            <severity value="error"/>
            <human value="All FHIR elements must have a @value or children"/>
            <expression
                        value="hasValue() or (children().count() &gt; id.count())"/>
            <source value="http://hl7.org/fhir/StructureDefinition/Element"/>
          </constraint>
          <constraint>
            <key value="ext-1"/>
            <severity value="error"/>
            <human value="Must have either extensions or value[x], not both"/>
            <expression value="extension.exists() != value.exists()"/>
            <source value="http://hl7.org/fhir/StructureDefinition/Extension"/>
          </constraint>
          <isModifier value="false"/>
          <isSummary value="false"/>
          <mapping>
            <identity value="rim"/>
            <map value="n/a"/>
          </mapping>
        </element>
        <element id="SubstanceDefinition.relationship.modifierExtension">
          <path value="SubstanceDefinition.relationship.modifierExtension"/>
          <short value="Extensions that cannot be ignored even if unrecognized"/>
          <definition
                      value="May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.

    Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself)."/>
          <comment
                   value="There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions.  The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone."/>
          <requirements
                        value="Modifier extensions allow for extensions that *cannot* be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored.  This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the [definition of modifier extensions](http://hl7.org/fhir/R5/extensibility.html#modifierExtension)."/>
          <alias value="extensions"/>
          <alias value="user content"/>
          <alias value="modifiers"/>
          <min value="0"/>
          <max value="*"/>
          <base>
            <path value="BackboneElement.modifierExtension"/>
            <min value="0"/>
            <max value="*"/>
          </base>
          <type>
            <code value="Extension"/>
          </type>
          <constraint>
            <key value="ele-1"/>
            <severity value="error"/>
            <human value="All FHIR elements must have a @value or children"/>
            <expression
                        value="hasValue() or (children().count() &gt; id.count())"/>
            <source value="http://hl7.org/fhir/StructureDefinition/Element"/>
          </constraint>
          <constraint>
            <key value="ext-1"/>
            <severity value="error"/>
            <human value="Must have either extensions or value[x], not both"/>
            <expression value="extension.exists() != value.exists()"/>
            <source value="http://hl7.org/fhir/StructureDefinition/Extension"/>
          </constraint>
          <isModifier value="true"/>
          <isModifierReason
                            value="Modifier extensions are expected to modify the meaning or interpretation of the element that contains them"/>
          <isSummary value="true"/>
          <mapping>
            <identity value="rim"/>
            <map value="N/A"/>
          </mapping>
        </element>
        <element id="SubstanceDefinition.relationship.substanceDefinition[x]">
          <path value="SubstanceDefinition.relationship.substanceDefinition[x]"/>
          <short
                 value="A pointer to another substance, as a resource or a representational code"/>
          <definition
                      value="A pointer to another substance, as a resource or just a representational code."/>
          <min value="0"/>
          <max value="1"/>
          <base>
            <path
                  value="SubstanceDefinition.relationship.substanceDefinition[x]"/>
            <min value="0"/>
            <max value="1"/>
          </base>
          <type>
            <code value="Reference"/>
            <targetProfile
                           value="http://hl7.org/fhir/StructureDefinition/SubstanceDefinition"/>
          </type>
          <type>
            <code value="CodeableConcept"/>
          </type>
          <constraint>
            <key value="ele-1"/>
            <severity value="error"/>
            <human value="All FHIR elements must have a @value or children"/>
            <expression
                        value="hasValue() or (children().count() &gt; id.count())"/>
            <source value="http://hl7.org/fhir/StructureDefinition/Element"/>
          </constraint>
          <mustSupport value="false"/>
          <isModifier value="false"/>
          <isSummary value="true"/>
          <mapping>
            <identity value="idmp-substance"/>
            <map value="Substance_Relationship.Related_Substance_Id"/>
          </mapping>
        </element>
        <element id="SubstanceDefinition.relationship.type">
          <path value="SubstanceDefinition.relationship.type"/>
          <short
                 value="For example &quot;salt to parent&quot;, &quot;active moiety&quot;"/>
          <definition
                      value="For example &quot;salt to parent&quot;, &quot;active moiety&quot;, &quot;starting material&quot;, &quot;polymorph&quot;, &quot;impurity of&quot;."/>
          <min value="1"/>
          <max value="1"/>
          <base>
            <path value="SubstanceDefinition.relationship.type"/>
            <min value="1"/>
            <max value="1"/>
          </base>
          <type>
            <code value="CodeableConcept"/>
          </type>
          <constraint>
            <key value="ele-1"/>
            <severity value="error"/>
            <human value="All FHIR elements must have a @value or children"/>
            <expression
                        value="hasValue() or (children().count() &gt; id.count())"/>
            <source value="http://hl7.org/fhir/StructureDefinition/Element"/>
          </constraint>
          <mustSupport value="false"/>
          <isModifier value="false"/>
          <isSummary value="true"/>
          <binding>
            <extension
                       url="http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName">
              <valueString value="SubstanceRelationshipType"/>
            </extension>
            <strength value="example"/>
            <description value="The relationship between two substance types."/>
            <valueSet
                      value="http://hl7.org/fhir/ValueSet/substance-relationship-type"/>
          </binding>
          <mapping>
            <identity value="idmp-substance"/>
            <map value="Substance_Relationship.Relationship_Type"/>
          </mapping>
        </element>
        <element id="SubstanceDefinition.relationship.isDefining">
          <path value="SubstanceDefinition.relationship.isDefining"/>
          <short
                 value="For example where an enzyme strongly bonds with a particular substance, this is a defining relationship for that enzyme, out of several possible relationships"/>
          <definition
                      value="For example where an enzyme strongly bonds with a particular substance, this is a defining relationship for that enzyme, out of several possible substance relationships."/>
          <min value="0"/>
          <max value="1"/>
          <base>
            <path value="SubstanceDefinition.relationship.isDefining"/>
            <min value="0"/>
            <max value="1"/>
          </base>
          <type>
            <code value="boolean"/>
          </type>
          <meaningWhenMissing
                              value="If this value is not present, there is no statement being made about whether this is a defining relationship or not. No inference can be made"/>
          <constraint>
            <key value="ele-1"/>
            <severity value="error"/>
            <human value="All FHIR elements must have a @value or children"/>
            <expression
                        value="hasValue() or (children().count() &gt; id.count())"/>
            <source value="http://hl7.org/fhir/StructureDefinition/Element"/>
          </constraint>
          <mustSupport value="false"/>
          <isModifier value="false"/>
          <isSummary value="true"/>
          <mapping>
            <identity value="idmp-substance"/>
            <map value="Substance_Relationship.Is_Defining"/>
          </mapping>
        </element>
        <element id="SubstanceDefinition.relationship.amount[x]">
          <path value="SubstanceDefinition.relationship.amount[x]"/>
          <short
                 value="A numeric factor for the relationship, e.g. that a substance salt has some percentage of active substance in relation to some other"/>
          <definition
                      value="A numeric factor for the relationship, for instance to express that the salt of a substance has some percentage of the active substance in relation to some other."/>
          <min value="0"/>
          <max value="1"/>
          <base>
            <path value="SubstanceDefinition.relationship.amount[x]"/>
            <min value="0"/>
            <max value="1"/>
          </base>
          <type>
            <code value="Quantity"/>
          </type>
          <type>
            <code value="Ratio"/>
          </type>
          <type>
            <code value="string"/>
          </type>
          <constraint>
            <key value="ele-1"/>
            <severity value="error"/>
            <human value="All FHIR elements must have a @value or children"/>
            <expression
                        value="hasValue() or (children().count() &gt; id.count())"/>
            <source value="http://hl7.org/fhir/StructureDefinition/Element"/>
          </constraint>
          <mustSupport value="false"/>
          <isModifier value="false"/>
          <isSummary value="true"/>
          <mapping>
            <identity value="idmp-substance"/>
            <map value="Substance_Relationship.Amount.Quantity"/>
          </mapping>
        </element>
        <element id="SubstanceDefinition.relationship.ratioHighLimitAmount">
          <path value="SubstanceDefinition.relationship.ratioHighLimitAmount"/>
          <short value="For use when the numeric has an uncertain range"/>
          <definition value="For use when the numeric has an uncertain range."/>
          <min value="0"/>
          <max value="1"/>
          <base>
            <path value="SubstanceDefinition.relationship.ratioHighLimitAmount"/>
            <min value="0"/>
            <max value="1"/>
          </base>
          <type>
            <code value="Ratio"/>
          </type>
          <constraint>
            <key value="ele-1"/>
            <severity value="error"/>
            <human value="All FHIR elements must have a @value or children"/>
            <expression
                        value="hasValue() or (children().count() &gt; id.count())"/>
            <source value="http://hl7.org/fhir/StructureDefinition/Element"/>
          </constraint>
          <mustSupport value="false"/>
          <isModifier value="false"/>
          <isSummary value="true"/>
          <mapping>
            <identity value="idmp-substance"/>
            <map value="Substance_Relationship.Amount.Quantity.High_Limit"/>
          </mapping>
        </element>
        <element id="SubstanceDefinition.relationship.comparator">
          <path value="SubstanceDefinition.relationship.comparator"/>
          <short
                 value="An operator for the amount, for example &quot;average&quot;, &quot;approximately&quot;, &quot;less than&quot;"/>
          <definition
                      value="An operator for the amount, for example &quot;average&quot;, &quot;approximately&quot;, &quot;less than&quot;."/>
          <min value="0"/>
          <max value="1"/>
          <base>
            <path value="SubstanceDefinition.relationship.comparator"/>
            <min value="0"/>
            <max value="1"/>
          </base>
          <type>
            <code value="CodeableConcept"/>
          </type>
          <constraint>
            <key value="ele-1"/>
            <severity value="error"/>
            <human value="All FHIR elements must have a @value or children"/>
            <expression
                        value="hasValue() or (children().count() &gt; id.count())"/>
            <source value="http://hl7.org/fhir/StructureDefinition/Element"/>
          </constraint>
          <mustSupport value="false"/>
          <isModifier value="false"/>
          <isSummary value="true"/>
          <binding>
            <extension
                       url="http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName">
              <valueString value="SubstanceAmountType"/>
            </extension>
            <strength value="example"/>
            <description value="The relationship between two substance types."/>
            <valueSet value="http://hl7.org/fhir/ValueSet/substance-amount-type"/>
          </binding>
          <mapping>
            <identity value="idmp-substance"/>
            <map value="Substance_Relationship.Amount_Type"/>
          </mapping>
        </element>
        <element id="SubstanceDefinition.relationship.source">
          <path value="SubstanceDefinition.relationship.source"/>
          <short value="Supporting literature"/>
          <definition value="Supporting literature."/>
          <min value="0"/>
          <max value="*"/>
          <base>
            <path value="SubstanceDefinition.relationship.source"/>
            <min value="0"/>
            <max value="*"/>
          </base>
          <type>
            <code value="Reference"/>
            <targetProfile
                           value="http://hl7.org/fhir/StructureDefinition/DocumentReference"/>
          </type>
          <constraint>
            <key value="ele-1"/>
            <severity value="error"/>
            <human value="All FHIR elements must have a @value or children"/>
            <expression
                        value="hasValue() or (children().count() &gt; id.count())"/>
            <source value="http://hl7.org/fhir/StructureDefinition/Element"/>
          </constraint>
          <mustSupport value="false"/>
          <isModifier value="false"/>
          <isSummary value="true"/>
          <mapping>
            <identity value="idmp-substance"/>
            <map value="Substance_Relationship.Reference_Source"/>
          </mapping>
        </element>
        <element id="SubstanceDefinition.nucleicAcid">
          <path value="SubstanceDefinition.nucleicAcid"/>
          <short value="Data items specific to nucleic acids"/>
          <definition value="Data items specific to nucleic acids."/>
          <min value="0"/>
          <max value="1"/>
          <base>
            <path value="SubstanceDefinition.nucleicAcid"/>
            <min value="0"/>
            <max value="1"/>
          </base>
          <type>
            <code value="Reference"/>
            <targetProfile
                           value="http://hl7.org/fhir/StructureDefinition/SubstanceNucleicAcid"/>
          </type>
          <constraint>
            <key value="ele-1"/>
            <severity value="error"/>
            <human value="All FHIR elements must have a @value or children"/>
            <expression
                        value="hasValue() or (children().count() &gt; id.count())"/>
            <source value="http://hl7.org/fhir/StructureDefinition/Element"/>
          </constraint>
          <mustSupport value="false"/>
          <isModifier value="false"/>
          <isSummary value="true"/>
          <mapping>
            <identity value="idmp-substance"/>
            <map value="(used to add specifics of Nucleic Acids to Substances)"/>
          </mapping>
        </element>
        <element id="SubstanceDefinition.polymer">
          <path value="SubstanceDefinition.polymer"/>
          <short value="Data items specific to polymers"/>
          <definition value="Data items specific to polymers."/>
          <min value="0"/>
          <max value="1"/>
          <base>
            <path value="SubstanceDefinition.polymer"/>
            <min value="0"/>
            <max value="1"/>
          </base>
          <type>
            <code value="Reference"/>
            <targetProfile
                           value="http://hl7.org/fhir/StructureDefinition/SubstancePolymer"/>
          </type>
          <constraint>
            <key value="ele-1"/>
            <severity value="error"/>
            <human value="All FHIR elements must have a @value or children"/>
            <expression
                        value="hasValue() or (children().count() &gt; id.count())"/>
            <source value="http://hl7.org/fhir/StructureDefinition/Element"/>
          </constraint>
          <mustSupport value="false"/>
          <isModifier value="false"/>
          <isSummary value="true"/>
          <mapping>
            <identity value="idmp-substance"/>
            <map value="(used to  add specifics of Polymers to Substances)"/>
          </mapping>
        </element>
        <element id="SubstanceDefinition.protein">
          <path value="SubstanceDefinition.protein"/>
          <short value="Data items specific to proteins"/>
          <definition value="Data items specific to proteins."/>
          <min value="0"/>
          <max value="1"/>
          <base>
            <path value="SubstanceDefinition.protein"/>
            <min value="0"/>
            <max value="1"/>
          </base>
          <type>
            <code value="Reference"/>
            <targetProfile
                           value="http://hl7.org/fhir/StructureDefinition/SubstanceProtein"/>
          </type>
          <constraint>
            <key value="ele-1"/>
            <severity value="error"/>
            <human value="All FHIR elements must have a @value or children"/>
            <expression
                        value="hasValue() or (children().count() &gt; id.count())"/>
            <source value="http://hl7.org/fhir/StructureDefinition/Element"/>
          </constraint>
          <mustSupport value="false"/>
          <isModifier value="false"/>
          <isSummary value="true"/>
          <mapping>
            <identity value="idmp-substance"/>
            <map value="(used to  add specifics of Proteins to Substances)"/>
          </mapping>
        </element>
        <element id="SubstanceDefinition.sourceMaterial">
          <path value="SubstanceDefinition.sourceMaterial"/>
          <short value="Material or taxonomic/anatomical source"/>
          <definition
                      value="Material or taxonomic/anatomical source for the substance."/>
          <min value="0"/>
          <max value="1"/>
          <base>
            <path value="SubstanceDefinition.sourceMaterial"/>
            <min value="0"/>
            <max value="1"/>
          </base>
          <type>
            <code value="BackboneElement"/>
          </type>
          <constraint>
            <key value="ele-1"/>
            <severity value="error"/>
            <human value="All FHIR elements must have a @value or children"/>
            <expression
                        value="hasValue() or (children().count() &gt; id.count())"/>
            <source value="http://hl7.org/fhir/StructureDefinition/Element"/>
          </constraint>
          <mustSupport value="true"/>
          <isModifier value="false"/>
          <isSummary value="true"/>
          <mapping>
            <identity value="idmp-substance"/>
            <map value="Substance.Source_Material"/>
          </mapping>
        </element>
        <element id="SubstanceDefinition.sourceMaterial.id">
          <path value="SubstanceDefinition.sourceMaterial.id"/>
          <representation value="xmlAttr"/>
          <short value="Unique id for inter-element referencing"/>
          <definition
                      value="Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces."/>
          <min value="0"/>
          <max value="1"/>
          <base>
            <path value="Element.id"/>
            <min value="0"/>
            <max value="1"/>
          </base>
          <type>
            <extension
                       url="http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type">
              <valueUrl value="string"/>
            </extension>
            <code value="http://hl7.org/fhirpath/System.String"/>
          </type>
          <condition value="ele-1"/>
          <isModifier value="false"/>
          <isSummary value="false"/>
          <mapping>
            <identity value="rim"/>
            <map value="n/a"/>
          </mapping>
        </element>
        <element id="SubstanceDefinition.sourceMaterial.extension">
          <path value="SubstanceDefinition.sourceMaterial.extension"/>
          <short value="Additional content defined by implementations"/>
          <definition
                      value="May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension."/>
          <comment
                   value="There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions.  The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone."/>
          <alias value="extensions"/>
          <alias value="user content"/>
          <min value="0"/>
          <max value="*"/>
          <base>
            <path value="Element.extension"/>
            <min value="0"/>
            <max value="*"/>
          </base>
          <type>
            <code value="Extension"/>
          </type>
          <constraint>
            <key value="ele-1"/>
            <severity value="error"/>
            <human value="All FHIR elements must have a @value or children"/>
            <expression
                        value="hasValue() or (children().count() &gt; id.count())"/>
            <source value="http://hl7.org/fhir/StructureDefinition/Element"/>
          </constraint>
          <constraint>
            <key value="ext-1"/>
            <severity value="error"/>
            <human value="Must have either extensions or value[x], not both"/>
            <expression value="extension.exists() != value.exists()"/>
            <source value="http://hl7.org/fhir/StructureDefinition/Extension"/>
          </constraint>
          <isModifier value="false"/>
          <isSummary value="false"/>
          <mapping>
            <identity value="rim"/>
            <map value="n/a"/>
          </mapping>
        </element>
        <element id="SubstanceDefinition.sourceMaterial.modifierExtension">
          <path value="SubstanceDefinition.sourceMaterial.modifierExtension"/>
          <short value="Extensions that cannot be ignored even if unrecognized"/>
          <definition
                      value="May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.

    Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself)."/>
          <comment
                   value="There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions.  The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone."/>
          <requirements
                        value="Modifier extensions allow for extensions that *cannot* be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored.  This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the [definition of modifier extensions](http://hl7.org/fhir/R5/extensibility.html#modifierExtension)."/>
          <alias value="extensions"/>
          <alias value="user content"/>
          <alias value="modifiers"/>
          <min value="0"/>
          <max value="*"/>
          <base>
            <path value="BackboneElement.modifierExtension"/>
            <min value="0"/>
            <max value="*"/>
          </base>
          <type>
            <code value="Extension"/>
          </type>
          <constraint>
            <key value="ele-1"/>
            <severity value="error"/>
            <human value="All FHIR elements must have a @value or children"/>
            <expression
                        value="hasValue() or (children().count() &gt; id.count())"/>
            <source value="http://hl7.org/fhir/StructureDefinition/Element"/>
          </constraint>
          <constraint>
            <key value="ext-1"/>
            <severity value="error"/>
            <human value="Must have either extensions or value[x], not both"/>
            <expression value="extension.exists() != value.exists()"/>
            <source value="http://hl7.org/fhir/StructureDefinition/Extension"/>
          </constraint>
          <isModifier value="true"/>
          <isModifierReason
                            value="Modifier extensions are expected to modify the meaning or interpretation of the element that contains them"/>
          <isSummary value="true"/>
          <mapping>
            <identity value="rim"/>
            <map value="N/A"/>
          </mapping>
        </element>
        <element id="SubstanceDefinition.sourceMaterial.type">
          <path value="SubstanceDefinition.sourceMaterial.type"/>
          <short value="Source Type"/>
          <definition
                      value="A classification that provides the origin of the raw material. [Source: SME Defined]"/>
          <min value="0"/>
          <max value="1"/>
          <base>
            <path value="SubstanceDefinition.sourceMaterial.type"/>
            <min value="0"/>
            <max value="1"/>
          </base>
          <type>
            <code value="CodeableConcept"/>
          </type>
          <constraint>
            <key value="ele-1"/>
            <severity value="error"/>
            <human value="All FHIR elements must have a @value or children"/>
            <expression
                        value="hasValue() or (children().count() &gt; id.count())"/>
            <source value="http://hl7.org/fhir/StructureDefinition/Element"/>
          </constraint>
          <mustSupport value="true"/>
          <isModifier value="false"/>
          <isSummary value="true"/>
          <binding>
            <strength value="required"/>
            <valueSet
                      value="http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-source-type-terminology"/>
          </binding>
          <mapping>
            <identity value="idmp-substance"/>
            <map value="Source_Material.Source_Material_Type"/>
          </mapping>
        </element>
        <element id="SubstanceDefinition.sourceMaterial.genus">
          <path value="SubstanceDefinition.sourceMaterial.genus"/>
          <short value="Source Organism Genus"/>
          <definition
                      value="The name, genus or genus and species of the organism from which the material is derived. [Source: SME Defined]
    Examples: human or Homo Sapiens, chicken, dog or canine, cow or bovine, rat or rattus."/>
          <min value="0"/>
          <max value="1"/>
          <base>
            <path value="SubstanceDefinition.sourceMaterial.genus"/>
            <min value="0"/>
            <max value="1"/>
          </base>
          <type>
            <code value="CodeableConcept"/>
            <profile
                     value="http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/codeable-concept-text-only"/>
          </type>
          <constraint>
            <key value="ele-1"/>
            <severity value="error"/>
            <human value="All FHIR elements must have a @value or children"/>
            <expression
                        value="hasValue() or (children().count() &gt; id.count())"/>
            <source value="http://hl7.org/fhir/StructureDefinition/Element"/>
          </constraint>
          <mustSupport value="true"/>
          <isModifier value="false"/>
          <isSummary value="true"/>
          <binding>
            <extension
                       url="http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName">
              <valueString value="SourceMaterialGenus"/>
            </extension>
            <strength value="example"/>
            <description
                         value="The genus of an organism, typically referring to the Latin epithet of the genus element of the plant/animal scientific name."/>
            <valueSet
                      value="http://hl7.org/fhir/ValueSet/substance-source-material-genus"/>
          </binding>
          <mapping>
            <identity value="idmp-substance"/>
            <map value="Source_Material.Organism.Genus"/>
          </mapping>
        </element>
        <element id="SubstanceDefinition.sourceMaterial.species">
          <path value="SubstanceDefinition.sourceMaterial.species"/>
          <short value="Source Organism Species"/>
          <definition
                      value="The name, genus or genus and species of the organism from which the material is derived. [Source: SME Defined]
    Examples: Examples: human or Homo Sapiens, chicken, dog or canine, cow or bovine, rat or rattus."/>
          <min value="0"/>
          <max value="1"/>
          <base>
            <path value="SubstanceDefinition.sourceMaterial.species"/>
            <min value="0"/>
            <max value="1"/>
          </base>
          <type>
            <code value="CodeableConcept"/>
            <profile
                     value="http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/codeable-concept-text-only"/>
          </type>
          <constraint>
            <key value="ele-1"/>
            <severity value="error"/>
            <human value="All FHIR elements must have a @value or children"/>
            <expression
                        value="hasValue() or (children().count() &gt; id.count())"/>
            <source value="http://hl7.org/fhir/StructureDefinition/Element"/>
          </constraint>
          <mustSupport value="true"/>
          <isModifier value="false"/>
          <isSummary value="true"/>
          <binding>
            <extension
                       url="http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName">
              <valueString value="SourceMaterialSpecies"/>
            </extension>
            <strength value="example"/>
            <description value="A species of origin a substance raw material."/>
            <valueSet
                      value="http://hl7.org/fhir/ValueSet/substance-source-material-species"/>
          </binding>
          <mapping>
            <identity value="idmp-substance"/>
            <map value="Source_Material.Organism.Species"/>
          </mapping>
        </element>
        <element id="SubstanceDefinition.sourceMaterial.part">
          <path value="SubstanceDefinition.sourceMaterial.part"/>
          <short value="Source Organism Part"/>
          <definition
                      value="A fragment of the source organism. [Source: SME Defined]
    Examples: secretions, material from a specific organ, tissue or portion of the organism such as liver, pancreas, blood or from bark or seed of a plant.
    IDMP 11238 definition &amp; examples: Entity of anatomical origin of source material within an organism.
    Cartilage, Root and Stolon, whole plant is considered as a part, Aerial part of the plant, Leaf, Tuberous Root, whole animal"/>
          <min value="0"/>
          <max value="1"/>
          <base>
            <path value="SubstanceDefinition.sourceMaterial.part"/>
            <min value="0"/>
            <max value="1"/>
          </base>
          <type>
            <code value="CodeableConcept"/>
            <profile
                     value="http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/codeable-concept-text-only"/>
          </type>
          <constraint>
            <key value="ele-1"/>
            <severity value="error"/>
            <human value="All FHIR elements must have a @value or children"/>
            <expression
                        value="hasValue() or (children().count() &gt; id.count())"/>
            <source value="http://hl7.org/fhir/StructureDefinition/Element"/>
          </constraint>
          <mustSupport value="true"/>
          <isModifier value="false"/>
          <isSummary value="true"/>
          <binding>
            <extension
                       url="http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName">
              <valueString value="SourceMaterialPart"/>
            </extension>
            <strength value="example"/>
            <description
                         value="An anatomical origin of the source material within an organism."/>
            <valueSet
                      value="http://hl7.org/fhir/ValueSet/substance-source-material-part"/>
          </binding>
          <mapping>
            <identity value="idmp-substance"/>
            <map value="Source_Material.Part_Description.Part"/>
          </mapping>
        </element>
        <element id="SubstanceDefinition.sourceMaterial.countryOfOrigin">
          <path value="SubstanceDefinition.sourceMaterial.countryOfOrigin"/>
          <short value="Source Organism Country of Origin"/>
          <definition
                      value="The name of the country where the organism was reared. [Source: SME Defined]"/>
          <min value="0"/>
          <max value="1"/>
          <base>
            <path value="SubstanceDefinition.sourceMaterial.countryOfOrigin"/>
            <min value="0"/>
            <max value="*"/>
          </base>
          <type>
            <code value="CodeableConcept"/>
          </type>
          <constraint>
            <key value="ele-1"/>
            <severity value="error"/>
            <human value="All FHIR elements must have a @value or children"/>
            <expression
                        value="hasValue() or (children().count() &gt; id.count())"/>
            <source value="http://hl7.org/fhir/StructureDefinition/Element"/>
          </constraint>
          <mustSupport value="true"/>
          <isModifier value="false"/>
          <isSummary value="true"/>
          <binding>
            <strength value="required"/>
            <valueSet
                      value="http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-genc-and-iso-intersect"/>
          </binding>
          <mapping>
            <identity value="idmp-substance"/>
            <map value="Source_Material.Country_Of_Origin"/>
          </mapping>
        </element>
      </snapshot>
      <differential>
        <element id="SubstanceDefinition">
          <path value="SubstanceDefinition"/>
          <constraint>
            <key value="cmc-when-unii-required"/>
            <severity value="error"/>
            <human
                   value="A UNII is required in code for any of these categories: 'Chemical', 'Mixture', 'Nucleic Acids','Polymer'. A UniProt code is required for any of these categories: 'Protein'"/>
            <expression
                        value="(classification.coding.where(system = 'http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl' and (code in ('C48807' | 'C45305' | 'C706' | 'C48803'))).exists()
    implies code.where(
      code.coding.exists(system = 'http://fdasis.nlm.nih.gov')
    ).exists())
     and (classification.coding.where(
      system = 'http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl' and
      code = 'C17021'
    ).exists() implies code.where(
      code.coding.exists(system = 'http://terminology.hl7.org/NamingSystem/UniProt')
    ).exists())"/>
            <source
                    value="http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pqcmc-component-substance"/>
          </constraint>
          <constraint>
            <key value="cmc-name-isbt"/>
            <severity value="error"/>
            <human value="Name.type ISBT 128 required for blood products."/>
            <expression
                        value="classification.where(coding.where(code = '8' and system = 'http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl').exists()).exists() implies name.type.coding.exists(code = '226' and system = 'http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl')"/>
            <source
                    value="http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pqcmc-component-substance"/>
          </constraint>
          <constraint>
            <key value="cmc-source-material"/>
            <severity value="error"/>
            <human
                   value="IF raw material source type equals Microbial, Animal, Plant, Insect or Human THEN the 4 source related attributes are required and the manufacturer and supplier information is highly desirable."/>
            <expression
                        value="sourceMaterial.type.coding.where(system = 'http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl' and (code in 'C14182' | 'C14225' | 'C14227' | 'C14329' | 'C14258')).exists()
    implies (sourceMaterial.genus.exists() and  sourceMaterial.species.exists() and sourceMaterial.part.exists() and sourceMaterial.countryOfOrigin.exists())"/>
            <source
                    value="http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pqcmc-component-substance"/>
          </constraint>
        </element>
        <element id="SubstanceDefinition.identifier">
          <path value="SubstanceDefinition.identifier"/>
          <short value="optional user designated identifier"/>
          <max value="1"/>
        </element>
        <element id="SubstanceDefinition.classification">
          <path value="SubstanceDefinition.classification"/>
          <short value="Substance Type"/>
          <definition
                      value="A controlled vocabulary as provided by the prEN ISO 11238 - Health informatics identification of medicinal products - Structures and controlled vocabularies for drug substances to group drug substances at a relatively high level acording to the Substance and the Substance Preparation Model.
    [Source: Adapted from 'Logical model of the classification and identification of pharmaceutical and medicinal Products', HL7]"/>
          <min value="1"/>
          <max value="1"/>
          <mustSupport value="true"/>
          <binding>
            <strength value="required"/>
            <valueSet
                      value="http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/substance-classification"/>
          </binding>
        </element>
        <element id="SubstanceDefinition.grade">
          <path value="SubstanceDefinition.grade"/>
          <short value="Quality Standard"/>
          <definition
                      value="The established benchmark to which the component complies. [Source: SME Defined]
    Examples: USP/NF, EP, Company Standard"/>
          <min value="1"/>
          <binding>
            <strength value="required"/>
            <valueSet
                      value="http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-quality-benchmark-terminology"/>
          </binding>
        </element>
        <element id="SubstanceDefinition.manufacturer">
          <path value="SubstanceDefinition.manufacturer"/>
          <max value="1"/>
          <type>
            <code value="Reference"/>
            <profile
                     value="http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/literal-reference"/>
            <targetProfile
                           value="http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/cmc-organization"/>
            <aggregation value="bundled"/>
          </type>
          <mustSupport value="true"/>
        </element>
        <element id="SubstanceDefinition.supplier">
          <path value="SubstanceDefinition.supplier"/>
          <max value="1"/>
          <type>
            <code value="Reference"/>
            <profile
                     value="http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/literal-reference"/>
            <targetProfile
                           value="http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/cmc-organization"/>
            <aggregation value="bundled"/>
          </type>
          <mustSupport value="true"/>
        </element>
        <element id="SubstanceDefinition.structure">
          <path value="SubstanceDefinition.structure"/>
          <constraint>
            <key value="cmc-structure-representation-required"/>
            <severity value="error"/>
            <human
                   value="Either a file or string structure representation is required"/>
            <expression
                        value="representation.type.coding.where(
      system = 'http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl'
      and (code in 'C45253' | 'C103240')
    ).exists()"/>
            <source
                    value="http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pqcmc-component-substance"/>
          </constraint>
        </element>
        <element id="SubstanceDefinition.structure.representation">
          <path value="SubstanceDefinition.structure.representation"/>
          <slicing>
            <discriminator>
              <type value="value"/>
              <path value="type"/>
            </discriminator>
            <ordered value="false"/>
            <rules value="closed"/>
          </slicing>
          <short
                 value="Impurity Structure Graphic | Impurity Structure Data File"/>
          <mustSupport value="true"/>
        </element>
        <element id="SubstanceDefinition.structure.representation.type">
          <path value="SubstanceDefinition.structure.representation.type"/>
          <min value="1"/>
          <mustSupport value="true"/>
          <binding>
            <strength value="required"/>
            <valueSet
                      value="http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-representation-types"/>
          </binding>
        </element>
        <element id="SubstanceDefinition.structure.representation:graphic">
          <path value="SubstanceDefinition.structure.representation"/>
          <sliceName value="graphic"/>
          <short
                 value="A graphical, displayable depiction of the structure (e.g. an SVG, PNG)"/>
          <min value="0"/>
          <max value="1"/>
          <mustSupport value="true"/>
        </element>
        <element id="SubstanceDefinition.structure.representation:graphic.type">
          <path value="SubstanceDefinition.structure.representation.type"/>
          <short value="Graphic"/>
          <patternCodeableConcept>
            <coding>
              <system value="http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl"/>
              <code value="C54273"/>
            </coding>
          </patternCodeableConcept>
        </element>
        <element
                 id="SubstanceDefinition.structure.representation:graphic.document">
          <path value="SubstanceDefinition.structure.representation.document"/>
          <short value="Impurity Structure Graphic"/>
          <definition
                      value="A pictorial representation of the structure of the impurity substance.
    [Source: SME Defined] Note: Refer to the 'Acceptable File Formats for
    use in eCTD' Example: This is the representation of the molecule CH3OH,
    or the sequence SHLVEALALVAGERG."/>
          <min value="1"/>
          <type>
            <code value="Reference"/>
            <profile
                     value="http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/literal-reference"/>
            <targetProfile
                           value="http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pqcmc-graphic-reference"/>
            <aggregation value="bundled"/>
          </type>
        </element>
        <element id="SubstanceDefinition.structure.representation:structureFile">
          <path value="SubstanceDefinition.structure.representation"/>
          <sliceName value="structureFile"/>
          <short value="machine-readable representation -- attached file"/>
          <min value="0"/>
          <max value="*"/>
          <mustSupport value="true"/>
        </element>
        <element
                 id="SubstanceDefinition.structure.representation:structureFile.type">
          <path value="SubstanceDefinition.structure.representation.type"/>
          <short value="Structure File"/>
          <patternCodeableConcept>
            <coding>
              <system value="http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl"/>
              <code value="C103240"/>
            </coding>
          </patternCodeableConcept>
        </element>
        <element
                 id="SubstanceDefinition.structure.representation:structureFile.document">
          <path value="SubstanceDefinition.structure.representation.document"/>
          <short
                 value="Impurity Chemical Structure Data (files, e.g. .SDF, .CIF)"/>
          <min value="1"/>
          <type>
            <code value="Reference"/>
            <profile
                     value="http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/literal-reference"/>
            <targetProfile
                           value="http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pqcmc-structure-reference"/>
            <aggregation value="bundled"/>
          </type>
          <mustSupport value="true"/>
        </element>
        <element
                 id="SubstanceDefinition.structure.representation:structureString">
          <path value="SubstanceDefinition.structure.representation"/>
          <sliceName value="structureString"/>
          <short value="machine-readable representation -- plain text"/>
          <min value="0"/>
          <max value="*"/>
          <mustSupport value="true"/>
        </element>
        <element
                 id="SubstanceDefinition.structure.representation:structureString.type">
          <path value="SubstanceDefinition.structure.representation.type"/>
          <short value="Structure Textual"/>
          <patternCodeableConcept>
            <coding>
              <system value="http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl"/>
              <code value="C45253"/>
            </coding>
          </patternCodeableConcept>
        </element>
        <element
                 id="SubstanceDefinition.structure.representation:structureString.representation">
          <path
                value="SubstanceDefinition.structure.representation.representation"/>
          <short
                 value="Impurity Chemical Structure Data (short, plain text representations, e.g. SMILES)"/>
          <definition
                      value="A machine-readable representation of the structure of the chemical. [Source: SME Defined]
    Examples: SMILES, INCHI"/>
          <min value="1"/>
          <mustSupport value="true"/>
        </element>
        <element
                 id="SubstanceDefinition.structure.representation:structureString.format">
          <path value="SubstanceDefinition.structure.representation.format"/>
          <short value="Drug Substance Impurity Method Type"/>
          <min value="1"/>
          <mustSupport value="true"/>
          <binding>
            <strength value="required"/>
            <valueSet
                      value="http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-chemical-structure-datafile-type-terminology"/>
          </binding>
        </element>
        <element id="SubstanceDefinition.code">
          <path value="SubstanceDefinition.code"/>
          <slicing>
            <discriminator>
              <type value="value"/>
              <path value="code.coding.system"/>
            </discriminator>
            <rules value="open"/>
          </slicing>
          <min value="1"/>
          <mustSupport value="true"/>
        </element>
        <element id="SubstanceDefinition.code:unii">
          <path value="SubstanceDefinition.code"/>
          <sliceName value="unii"/>
          <short value="UNII"/>
          <definition
                      value="The UNII is a non-proprietary, free, unique, unambiguous, non-semantic, alphanumeric identifier based on a substance’s molecular structure and/or descriptive information. [Source: http://www.fda.gov/ForIndustry/DataStandards/SubstanceRegistrationSystem-UniqueIngredientIdentifierUNII/]
    Example: 362O9ITL9D
    Note: If a UNII does not exist, please go to http://www.fda.gov/ForIndustry/DataStandards/SubstanceRegistrationSystem-UniqueIngredientIdentifierUNII/"/>
          <min value="0"/>
          <max value="1"/>
          <mustSupport value="true"/>
        </element>
        <element id="SubstanceDefinition.code:unii.code">
          <path value="SubstanceDefinition.code.code"/>
          <min value="1"/>
          <mustSupport value="true"/>
        </element>
        <element id="SubstanceDefinition.code:unii.code.coding">
          <path value="SubstanceDefinition.code.code.coding"/>
          <min value="1"/>
          <max value="1"/>
          <mustSupport value="true"/>
        </element>
        <element id="SubstanceDefinition.code:unii.code.coding.system">
          <path value="SubstanceDefinition.code.code.coding.system"/>
          <min value="1"/>
          <patternUri value="http://fdasis.nlm.nih.gov"/>
          <mustSupport value="true"/>
        </element>
        <element id="SubstanceDefinition.code:uniProt">
          <path value="SubstanceDefinition.code"/>
          <sliceName value="uniProt"/>
          <short value="UniProt ID"/>
          <definition
                      value="The  UniProt ID is an index to the UniProt knowledgebase,  a large resource of protein sequences and associated detailed annotation.
    It is accessible at https://www.uniprot.org/"/>
          <min value="0"/>
          <max value="1"/>
          <mustSupport value="true"/>
        </element>
        <element id="SubstanceDefinition.code:uniProt.code">
          <path value="SubstanceDefinition.code.code"/>
          <min value="1"/>
          <mustSupport value="true"/>
        </element>
        <element id="SubstanceDefinition.code:uniProt.code.coding">
          <path value="SubstanceDefinition.code.code.coding"/>
          <min value="1"/>
          <max value="1"/>
          <mustSupport value="true"/>
        </element>
        <element id="SubstanceDefinition.code:uniProt.code.coding.system">
          <path value="SubstanceDefinition.code.code.coding.system"/>
          <min value="1"/>
          <patternUri value="http://terminology.hl7.org/NamingSystem/UniProt"/>
          <mustSupport value="true"/>
        </element>
        <element id="SubstanceDefinition.name">
          <path value="SubstanceDefinition.name"/>
          <slicing>
            <discriminator>
              <type value="value"/>
              <path value="type"/>
            </discriminator>
            <description value="Slice based on value pattern"/>
            <rules value="closed"/>
          </slicing>
          <short value="Substance Name"/>
          <definition
                      value="Substance Name is identified by its Substance Type.
    Substance Type | Product Part Ingredient Name Type: Identifies the source that assigned the product ingredient name. [Source: SME Defined]
    Examples: GSRS Preferred Term, Systematic Name, INN, USP/NF"/>
          <min value="1"/>
          <constraint>
            <key value="cmc-name-preferred"/>
            <severity value="error"/>
            <human value="Name.preferred: at most one = true"/>
            <expression value="select(preferred = true).count() &lt; 2"/>
            <source
                    value="http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pqcmc-component-substance"/>
          </constraint>
          <mustSupport value="true"/>
        </element>
        <element id="SubstanceDefinition.name.type">
          <path value="SubstanceDefinition.name.type"/>
          <binding>
            <strength value="required"/>
            <valueSet
                      value="http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-substance-name-type"/>
          </binding>
        </element>
        <element id="SubstanceDefinition.name.preferred">
          <path value="SubstanceDefinition.name.preferred"/>
          <short value="True when the name type is Substance Name"/>
          <mustSupport value="true"/>
        </element>
        <element id="SubstanceDefinition.name:sub">
          <path value="SubstanceDefinition.name"/>
          <sliceName value="sub"/>
          <min value="0"/>
          <max value="1"/>
          <mustSupport value="true"/>
        </element>
        <element id="SubstanceDefinition.name:sub.name">
          <path value="SubstanceDefinition.name.name"/>
          <short value="Generic Name"/>
          <definition
                      value="A non-branded nor registered name that meant for common use."/>
          <mustSupport value="true"/>
        </element>
        <element id="SubstanceDefinition.name:sub.type">
          <path value="SubstanceDefinition.name.type"/>
          <min value="1"/>
          <patternCodeableConcept>
            <coding>
              <system value="http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl"/>
              <code value="C97054"/>
              <display value="Generic Name"/>
            </coding>
          </patternCodeableConcept>
          <mustSupport value="true"/>
        </element>
        <element id="SubstanceDefinition.name:sub.preferred">
          <path value="SubstanceDefinition.name.preferred"/>
          <mustSupport value="true"/>
        </element>
        <element id="SubstanceDefinition.name:gsrs">
          <path value="SubstanceDefinition.name"/>
          <sliceName value="gsrs"/>
          <min value="0"/>
          <max value="1"/>
          <mustSupport value="true"/>
        </element>
        <element id="SubstanceDefinition.name:gsrs.name">
          <path value="SubstanceDefinition.name.name"/>
          <short value="GSRS Preferred Term"/>
          <definition
                      value="Default display name identified within FDA Global Substance Registration System (GSRS)."/>
          <mustSupport value="true"/>
        </element>
        <element id="SubstanceDefinition.name:gsrs.type">
          <path value="SubstanceDefinition.name.type"/>
          <min value="1"/>
          <patternCodeableConcept>
            <coding>
              <system value="http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl"/>
              <code value="C203355"/>
              <display value="GSRS Preferred Term"/>
            </coding>
          </patternCodeableConcept>
          <mustSupport value="true"/>
        </element>
        <element id="SubstanceDefinition.name:gsrs.preferred">
          <path value="SubstanceDefinition.name.preferred"/>
          <mustSupport value="true"/>
        </element>
        <element id="SubstanceDefinition.name:isbt">
          <path value="SubstanceDefinition.name"/>
          <sliceName value="isbt"/>
          <min value="0"/>
          <max value="1"/>
          <mustSupport value="true"/>
        </element>
        <element id="SubstanceDefinition.name:isbt.name">
          <path value="SubstanceDefinition.name.name"/>
          <short value="ISBT-128 DIN"/>
          <definition
                      value="It is the global standard for the terminology, identification, coding and labeling of medical products of human origin (including blood, cell, tissue, milk, and organ products). [Source: https://www.iccbba.org/]"/>
          <mustSupport value="true"/>
        </element>
        <element id="SubstanceDefinition.name:isbt.type">
          <path value="SubstanceDefinition.name.type"/>
          <min value="1"/>
          <patternCodeableConcept>
            <coding>
              <system value="http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl"/>
              <code value="C95517"/>
              <display value="ISBT-128 DIN"/>
            </coding>
          </patternCodeableConcept>
          <mustSupport value="true"/>
        </element>
        <element id="SubstanceDefinition.name:isbt.preferred">
          <path value="SubstanceDefinition.name.preferred"/>
          <mustSupport value="true"/>
        </element>
        <element id="SubstanceDefinition.sourceMaterial">
          <path value="SubstanceDefinition.sourceMaterial"/>
          <mustSupport value="true"/>
        </element>
        <element id="SubstanceDefinition.sourceMaterial.type">
          <path value="SubstanceDefinition.sourceMaterial.type"/>
          <short value="Source Type"/>
          <definition
                      value="A classification that provides the origin of the raw material. [Source: SME Defined]"/>
          <mustSupport value="true"/>
          <binding>
            <strength value="required"/>
            <valueSet
                      value="http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-source-type-terminology"/>
          </binding>
        </element>
        <element id="SubstanceDefinition.sourceMaterial.genus">
          <path value="SubstanceDefinition.sourceMaterial.genus"/>
          <short value="Source Organism Genus"/>
          <definition
                      value="The name, genus or genus and species of the organism from which the material is derived. [Source: SME Defined]
    Examples: human or Homo Sapiens, chicken, dog or canine, cow or bovine, rat or rattus."/>
          <type>
            <code value="CodeableConcept"/>
            <profile
                     value="http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/codeable-concept-text-only"/>
          </type>
          <mustSupport value="true"/>
        </element>
        <element id="SubstanceDefinition.sourceMaterial.species">
          <path value="SubstanceDefinition.sourceMaterial.species"/>
          <short value="Source Organism Species"/>
          <definition
                      value="The name, genus or genus and species of the organism from which the material is derived. [Source: SME Defined]
    Examples: Examples: human or Homo Sapiens, chicken, dog or canine, cow or bovine, rat or rattus."/>
          <type>
            <code value="CodeableConcept"/>
            <profile
                     value="http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/codeable-concept-text-only"/>
          </type>
          <mustSupport value="true"/>
        </element>
        <element id="SubstanceDefinition.sourceMaterial.part">
          <path value="SubstanceDefinition.sourceMaterial.part"/>
          <short value="Source Organism Part"/>
          <definition
                      value="A fragment of the source organism. [Source: SME Defined]
    Examples: secretions, material from a specific organ, tissue or portion of the organism such as liver, pancreas, blood or from bark or seed of a plant.
    IDMP 11238 definition &amp; examples: Entity of anatomical origin of source material within an organism.
    Cartilage, Root and Stolon, whole plant is considered as a part, Aerial part of the plant, Leaf, Tuberous Root, whole animal"/>
          <type>
            <code value="CodeableConcept"/>
            <profile
                     value="http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/codeable-concept-text-only"/>
          </type>
          <mustSupport value="true"/>
        </element>
        <element id="SubstanceDefinition.sourceMaterial.countryOfOrigin">
          <path value="SubstanceDefinition.sourceMaterial.countryOfOrigin"/>
          <short value="Source Organism Country of Origin"/>
          <definition
                      value="The name of the country where the organism was reared. [Source: SME Defined]"/>
          <max value="1"/>
          <mustSupport value="true"/>
          <binding>
            <strength value="required"/>
            <valueSet
                      value="http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-genc-and-iso-intersect"/>
          </binding>
        </element>
      </differential>
    </StructureDefinition>