Prototype ISO IDMP Compliant Datafeed to eHealth (Deliverable D4.12)
1.0.0 - STU1
Prototype ISO IDMP Compliant Datafeed to eHealth (Deliverable D4.12)
1.0.0 - STU1
Prototype ISO IDMP Compliant Datafeed to eHealth (Deliverable D4.12), published by UNICOM. This guide is not an authorized publication; it is the continuous build for version 1.0.0 built by the FHIR (HL7® FHIR® Standard) CI Build. This version is based on the current content of https://github.com/unicom-project-eu/d4.12/ and changes regularly. See the Directory of published versions
| Draft as of 2024-08-20 |
XML representation of the MedicinalProductD412 resource profile.
<StructureDefinition xmlns="http://hl7.org/fhir">
<id value="MedicinalProductD412"/>
<text>
<status value="extensions"/>
<div xmlns="http://www.w3.org/1999/xhtml"><p class="res-header-id"><b>Generated Narrative: StructureDefinition MedicinalProductD412</b></p><a name="MedicinalProductD412"> </a><a name="hcMedicinalProductD412"> </a><a name="MedicinalProductD412-en-US"> </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 : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" 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 : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" 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 : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" 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="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 : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="https://build.fhir.org/ig/FHIR/ig-guidance/readingIgs.html#table-views" title="Additional information about the element">Description & 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,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" 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 : 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-MedicinalProductD412-definitions.html#MedicinalProductDefinition">MedicinalProductDefinition</a><a name="MedicinalProductDefinition"> </a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="http://hl7.org/fhir/R5/medicinalproductdefinition.html">MedicinalProductDefinition</a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7"><td style="vertical-align: top; text-align : 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" href="StructureDefinition-MedicinalProductD412-definitions.html#MedicinalProductDefinition.identifier" title="EMA IG 1.2 & 1.3. Identifier for the medicinal product: MPID, EMA PMS ID, national ID, or other. Not to be used for package or pharmaceutical product identifiers.">Slices for identifier</a><a name="MedicinalProductDefinition.identifier"> </a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : 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 : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a style="opacity: 0.5; font-style: italic" href="http://hl7.org/fhir/R5/datatypes.html#Identifier">Identifier</a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><span style="font-style: italic">Identifier for the medicinal product: MPID, EMA PMS ID, national ID, or other</span><br style="font-style: italic"/><span style="font-weight:bold; font-style: italic">Slice: </span><span style="font-style: italic">Unordered, Open by pattern: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 : 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-MedicinalProductD412-definitions.html#MedicinalProductDefinition.identifier:mpid" title="Slice mpid: EMA IG 1.2. MPID if exists. For UNICOM testing data fake MPIDs are used (Country code + MAH LocID + unique code). ">identifier:mpid</a><a name="MedicinalProductDefinition.identifier.2"> </a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : 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 : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a style="opacity: 0.5" href="http://hl7.org/fhir/R5/datatypes.html#Identifier">Identifier</a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">MPID</td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7"><td style="vertical-align: top; text-align : 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-MedicinalProductD412-definitions.html#MedicinalProductDefinition.identifier:mpid.system">system</a><a name="MedicinalProductDefinition.identifier.system"> </a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : 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 : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a style="opacity: 0.5" href="http://hl7.org/fhir/R5/datatypes.html#uri">uri</a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><span style="opacity: 0.5">The namespace for the identifier value</span><br/><span style="font-weight:bold">Required Pattern: </span><span style="color: darkgreen">http://ema.europa.eu/fhir/mpId</span></td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white"><td style="vertical-align: top; text-align : 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-MedicinalProductD412-definitions.html#MedicinalProductDefinition.identifier:pmsid" title="Slice pmsid: EMA IG 1.1. EMA Product Management System identifier if exists. For UNICOM testing data fake PMS IDs can be used">identifier:pmsid</a><a name="MedicinalProductDefinition.identifier.3"> </a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : 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 : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a style="opacity: 0.5" href="http://hl7.org/fhir/R5/datatypes.html#Identifier">Identifier</a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">PMS ID</td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7"><td style="vertical-align: top; text-align : 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-MedicinalProductD412-definitions.html#MedicinalProductDefinition.identifier:pmsid.system">system</a><a name="MedicinalProductDefinition.identifier.system.2"> </a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : 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 : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a style="opacity: 0.5" href="http://hl7.org/fhir/R5/datatypes.html#uri">uri</a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><span style="opacity: 0.5">The namespace for the identifier value</span><br/><span style="font-weight:bold">Required Pattern: </span><span style="color: darkgreen">http://ema.europa.eu/fhir/pmsId</span></td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white"><td style="vertical-align: top; text-align : 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-MedicinalProductD412-definitions.html#MedicinalProductDefinition.domain" title="EMA IG 1.3">domain</a><a name="MedicinalProductDefinition.domain"> </a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : 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 : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a style="opacity: 0.5" href="http://hl7.org/fhir/R5/datatypes.html#CodeableConcept">CodeableConcept</a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><span style="opacity: 0.5">If this medicine applies to human or veterinary uses</span><br/><span style="font-weight:bold">Binding: </span><a href="ValueSet-domain-vs.html" title="http://unicom-project.eu/fhir/d4-12/ValueSet/domain-vs">EMA SPOR Domain</a> (<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.">required</a>)</td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7"><td style="vertical-align: top; text-align : 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-MedicinalProductD412-definitions.html#MedicinalProductDefinition.status">status</a><a name="MedicinalProductDefinition.status"> </a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : 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 : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a style="opacity: 0.5" href="http://hl7.org/fhir/R5/datatypes.html#CodeableConcept">CodeableConcept</a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">Status of the product's data. Default 200000005004 'Current'</td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white"><td style="vertical-align: top; text-align : 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-MedicinalProductD412-definitions.html#MedicinalProductDefinition.combinedPharmaceuticalDoseForm" title="EMA IG 1.5 & 1.6. Authorised dose form for the whole product. As applicable in one of the SPOR RMS list Combined pharmaceutical dose form, Pharmaceutical dose form, Combined term, Combination Package">combinedPharmaceuticalDoseForm</a><a name="MedicinalProductDefinition.combinedPharmaceuticalDoseForm"> </a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : 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 : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a style="opacity: 0.5" href="http://hl7.org/fhir/R5/datatypes.html#CodeableConcept">CodeableConcept</a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">Authorised dose form for the product, incl combination package dose forms<br/><span style="font-weight:bold">Binding: </span><a href="ValueSet-authorised-doseform-vs.html" title="http://unicom-project.eu/fhir/d4-12/ValueSet/authorised-doseform-vs">EMA SPOR Authorised Dose Form</a> (<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.">required</a>)</td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7"><td style="vertical-align: top; text-align : 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-MedicinalProductD412-definitions.html#MedicinalProductDefinition.legalStatusOfSupply" title="EMA IG 1.7. Legal status of supply on the medicinal product level. The same information can be repeated/differentiated on the package level">legalStatusOfSupply</a><a name="MedicinalProductDefinition.legalStatusOfSupply"> </a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : 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 : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a style="opacity: 0.5" href="http://hl7.org/fhir/R5/datatypes.html#CodeableConcept">CodeableConcept</a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">Legal status of supply on the medicinal product level.<br/><span style="font-weight:bold">Binding: </span><a href="ValueSet-legal-status-for-the-supply-vs.html" title="http://unicom-project.eu/fhir/d4-12/ValueSet/legal-status-for-the-supply-vs">EMA SPOR Legal Status for the Supply</a> (<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.">required</a>)</td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white"><td style="vertical-align: top; text-align : 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" href="StructureDefinition-MedicinalProductD412-definitions.html#MedicinalProductDefinition.classification" title="EMA IG 1.13">Slices for classification</a><a name="MedicinalProductDefinition.classification"> </a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: white; 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 : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a style="opacity: 0.5; font-style: italic" href="http://hl7.org/fhir/R5/datatypes.html#CodeableConcept">CodeableConcept</a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><span style="font-style: italic">ATC or other classification</span><br style="font-style: italic"/><span style="font-weight:bold; font-style: italic">Slice: </span><span style="font-style: italic">Unordered, Open by pattern:coding.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 : left; background-color: #F7F7F7; 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: #F7F7F7; background-color: inherit" title="Slice Item" class="hierarchy"/> <a href="StructureDefinition-MedicinalProductD412-definitions.html#MedicinalProductDefinition.classification:atc" title="Slice atc">classification:atc</a><a name="MedicinalProductDefinition.classification.2"> </a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">0..*</td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a style="opacity: 0.5" href="http://hl7.org/fhir/R5/datatypes.html#CodeableConcept">CodeableConcept</a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><span style="opacity: 0.5">Allows the product to be classified by various systems</span><br/></td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white"><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck1243.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_slice.png" alt="." style="background-color: white; background-color: inherit" title="Slice Definition" class="hierarchy"/> <a style="font-style: italic" href="StructureDefinition-MedicinalProductD412-definitions.html#MedicinalProductDefinition.classification:atc.coding" title="EMA IG 1.13.3">Slices for coding</a><a name="MedicinalProductDefinition.classification.coding"> </a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: white; 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 : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a style="opacity: 0.5; font-style: italic" href="http://hl7.org/fhir/R5/datatypes.html#Coding">Coding</a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><span style="font-style: italic">ATC classification</span><br style="font-style: italic"/><span style="font-weight:bold; font-style: italic">Slice: </span><span style="font-style: italic">Unordered, Open by pattern: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 : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck12435.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_slicer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_slice_item.png" alt="." style="background-color: #F7F7F7; background-color: inherit" title="Slice Item" class="hierarchy"/> <a href="StructureDefinition-MedicinalProductD412-definitions.html#MedicinalProductDefinition.classification:atc.coding:ema" title="Slice ema">coding:ema</a><a name="MedicinalProductDefinition.classification.coding.2"> </a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">0..1</td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a style="opacity: 0.5" href="http://hl7.org/fhir/R5/datatypes.html#Coding">Coding</a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">ATC classification as EMA SPOR code</td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white"><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck124340.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_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: white; background-color: inherit" title="Element" class="hierarchy"/> <a href="StructureDefinition-MedicinalProductD412-definitions.html#MedicinalProductDefinition.classification:atc.coding:ema.system">system</a><a name="MedicinalProductDefinition.classification.coding.system"> </a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : 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 : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a style="opacity: 0.5" href="http://hl7.org/fhir/R5/datatypes.html#uri">uri</a></td><td style="vertical-align: top; text-align : left; background-color: white; 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">https://spor.ema.europa.eu/v1/lists/100000093533</span></td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7"><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck12425.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_slicer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_slice_item.png" alt="." style="background-color: #F7F7F7; background-color: inherit" title="Slice Item" class="hierarchy"/> <a href="StructureDefinition-MedicinalProductD412-definitions.html#MedicinalProductDefinition.classification:atc.coding:who" title="Slice who">coding:who</a><a name="MedicinalProductDefinition.classification.coding.3"> </a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">0..1</td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a style="opacity: 0.5" href="http://hl7.org/fhir/R5/datatypes.html#Coding">Coding</a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">ATC classification as WHO ATC code</td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white"><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck124240.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_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-MedicinalProductD412-definitions.html#MedicinalProductDefinition.classification:atc.coding:who.system">system</a><a name="MedicinalProductDefinition.classification.coding.system.2"> </a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : 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 : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a style="opacity: 0.5" href="http://hl7.org/fhir/R5/datatypes.html#uri">uri</a></td><td style="vertical-align: top; text-align : left; background-color: white; 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://www.whocc.no/atc</span></td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7"><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; 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: #F7F7F7; background-color: inherit" title="Element" class="hierarchy"/> <a href="StructureDefinition-MedicinalProductD412-definitions.html#MedicinalProductDefinition.name" title="EMA IG 1.14">name</a><a name="MedicinalProductDefinition.name"> </a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : 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">*</span></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a style="opacity: 0.5" href="http://hl7.org/fhir/R5/types.html#BackboneElement">BackboneElement</a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><span style="opacity: 0.5">The product's name, including full name and possibly coded parts</span></td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white"><td style="vertical-align: top; text-align : 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_element.gif" alt="." style="background-color: white; background-color: inherit" title="Element" class="hierarchy"/> <a href="StructureDefinition-MedicinalProductD412-definitions.html#MedicinalProductDefinition.name.productName" title="EMA IG 1.14.1">productName</a><a name="MedicinalProductDefinition.name.productName"> </a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: white; 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 : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a style="opacity: 0.5" href="http://hl7.org/fhir/R5/datatypes.html#string">string</a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><span style="opacity: 0.5">The full product 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 : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck001.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-MedicinalProductD412-definitions.html#MedicinalProductDefinition.name.usage" title="EMA IG 1.14.2">usage</a><a name="MedicinalProductDefinition.name.usage"> </a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : 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">*</span></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a style="opacity: 0.5" href="http://hl7.org/fhir/R5/types.html#BackboneElement">BackboneElement</a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><span style="opacity: 0.5">Country and jurisdiction where the name applies</span></td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white"><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck0011.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_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: white; background-color: inherit" title="Element" class="hierarchy"/> <a href="StructureDefinition-MedicinalProductD412-definitions.html#MedicinalProductDefinition.name.usage.country">country</a><a name="MedicinalProductDefinition.name.usage.country"> </a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7"><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck00103.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_blank.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" href="StructureDefinition-MedicinalProductD412-definitions.html#MedicinalProductDefinition.name.usage.country.coding">Slices for coding</a><a name="MedicinalProductDefinition.name.usage.country.coding"> </a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : 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 : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a style="opacity: 0.5; font-style: italic" href="http://hl7.org/fhir/R5/datatypes.html#Coding">Coding</a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><span style="font-style: italic">EMA or ISO codes for country</span><br style="font-style: italic"/><span style="font-weight:bold; font-style: italic">Slice: </span><span style="font-style: italic">Unordered, Open by pattern: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 : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck001035.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_blank.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-MedicinalProductD412-definitions.html#MedicinalProductDefinition.name.usage.country.coding:ema" title="Slice ema">coding:ema</a><a name="MedicinalProductDefinition.name.usage.country.coding.2"> </a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : 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 : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a style="opacity: 0.5" href="http://hl7.org/fhir/R5/datatypes.html#Coding">Coding</a></td><td style="vertical-align: top; text-align : 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 : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck0010340.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_blank.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_element.gif" alt="." style="background-color: #F7F7F7; background-color: inherit" title="Element" class="hierarchy"/> <a href="StructureDefinition-MedicinalProductD412-definitions.html#MedicinalProductDefinition.name.usage.country.coding:ema.system">system</a><a name="MedicinalProductDefinition.name.usage.country.coding.system"> </a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : 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 : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a style="opacity: 0.5" href="http://hl7.org/fhir/R5/datatypes.html#uri">uri</a></td><td style="vertical-align: top; text-align : 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">https://spor.ema.europa.eu/v1/lists/100000000002</span></td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white"><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck001025.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_blank.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-MedicinalProductD412-definitions.html#MedicinalProductDefinition.name.usage.country.coding:iso" title="Slice iso">coding:iso</a><a name="MedicinalProductDefinition.name.usage.country.coding.3"> </a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : 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 : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a style="opacity: 0.5" href="http://hl7.org/fhir/R5/datatypes.html#Coding">Coding</a></td><td style="vertical-align: top; text-align : 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 : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck0010240.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_blank.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: #F7F7F7; background-color: inherit" title="Element" class="hierarchy"/> <a href="StructureDefinition-MedicinalProductD412-definitions.html#MedicinalProductDefinition.name.usage.country.coding:iso.system">system</a><a name="MedicinalProductDefinition.name.usage.country.coding.system.2"> </a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : 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 : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a style="opacity: 0.5" href="http://hl7.org/fhir/R5/datatypes.html#uri">uri</a></td><td style="vertical-align: top; text-align : 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">https://www.hl7.org/fhir/valueset-country.html</span></td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white"><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck0001.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_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-MedicinalProductD412-definitions.html#MedicinalProductDefinition.name.usage.language">language</a><a name="MedicinalProductDefinition.name.usage.language"> </a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7"><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck00003.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_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_slice.png" alt="." style="background-color: #F7F7F7; background-color: inherit" title="Slice Definition" class="hierarchy"/> <a style="font-style: italic" href="StructureDefinition-MedicinalProductD412-definitions.html#MedicinalProductDefinition.name.usage.language.coding">Slices for coding</a><a name="MedicinalProductDefinition.name.usage.language.coding"> </a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : 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 : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a style="opacity: 0.5; font-style: italic" href="http://hl7.org/fhir/R5/datatypes.html#Coding">Coding</a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><span style="font-style: italic">EMA or ISO codes for country</span><br style="font-style: italic"/><span style="font-weight:bold; font-style: italic">Slice: </span><span style="font-style: italic">Unordered, Open by pattern: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 : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck000035.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_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_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-MedicinalProductD412-definitions.html#MedicinalProductDefinition.name.usage.language.coding:ema" title="Slice ema">coding:ema</a><a name="MedicinalProductDefinition.name.usage.language.coding.2"> </a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : 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 : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a style="opacity: 0.5" href="http://hl7.org/fhir/R5/datatypes.html#Coding">Coding</a></td><td style="vertical-align: top; text-align : 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 : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck0000340.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_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_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-MedicinalProductD412-definitions.html#MedicinalProductDefinition.name.usage.language.coding:ema.system">system</a><a name="MedicinalProductDefinition.name.usage.language.coding.system"> </a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : 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 : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a style="opacity: 0.5" href="http://hl7.org/fhir/R5/datatypes.html#uri">uri</a></td><td style="vertical-align: top; text-align : 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">https://spor.ema.europa.eu/v1/lists/100000072057</span></td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white"><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck000025.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_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_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-MedicinalProductD412-definitions.html#MedicinalProductDefinition.name.usage.language.coding:bcp" title="Slice bcp">coding:bcp</a><a name="MedicinalProductDefinition.name.usage.language.coding.3"> </a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : 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 : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a style="opacity: 0.5" href="http://hl7.org/fhir/R5/datatypes.html#Coding">Coding</a></td><td style="vertical-align: top; text-align : 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 : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck0000240.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_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_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-MedicinalProductD412-definitions.html#MedicinalProductDefinition.name.usage.language.coding:bcp.system">system</a><a name="MedicinalProductDefinition.name.usage.language.coding.system.2"> </a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : 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 : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a style="opacity: 0.5" href="http://hl7.org/fhir/R5/datatypes.html#uri">uri</a></td><td style="vertical-align: top; text-align : 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://hl7.org/fhir/ValueSet/all-languages</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,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" alt="doco" style="background-color: inherit"/> Documentation for this format</a></td></tr></table></div>
</text>
<url
value="http://unicom-project.eu/fhir/d4-12/StructureDefinition/MedicinalProductD412"/>
<version value="1.0.0"/>
<name value="MedicinalProductD412"/>
<title value="Medicinal Product"/>
<status value="draft"/>
<date value="2024-08-20T21:53:59+00:00"/>
<publisher value="UNICOM"/>
<contact>
<name value="UNICOM"/>
<telecom>
<system value="url"/>
<value value="https://unicom-project.eu/"/>
</telecom>
</contact>
<contact>
<name value="Rutt Lindström"/>
<telecom>
<system value="email"/>
<value value="rutt.lindstrom@tehik.ee"/>
<use value="work"/>
</telecom>
</contact>
<description value="Medicinal Product data"/>
<jurisdiction>
<coding>
<system value="http://unstats.un.org/unsd/methods/m49/m49.htm"/>
<code value="001"/>
<display value="World"/>
</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"/>
<uri value="https://www.iso.org/obp/ui/#iso:std:iso:11615"/>
<name value="IDMP Mapping"/>
</mapping>
<mapping>
<identity value="rim"/>
<uri value="http://hl7.org/v3"/>
<name value="RIM Mapping"/>
</mapping>
<kind value="resource"/>
<abstract value="false"/>
<type value="MedicinalProductDefinition"/>
<baseDefinition
value="http://hl7.org/fhir/StructureDefinition/MedicinalProductDefinition"/>
<derivation value="constraint"/>
<snapshot>
<element id="MedicinalProductDefinition">
<path value="MedicinalProductDefinition"/>
<short value="Detailed definition of a medicinal product"/>
<definition
value="A medicinal product, being a substance or combination of substances that is intended to treat, prevent or diagnose a disease, or to restore, correct or modify physiological functions by exerting a pharmacological, immunological or metabolic action. This resource is intended to define and detail such products and their properties, for uses other than direct patient care (e.g. regulatory use, or drug catalogs)."/>
<min value="0"/>
<max value="*"/>
<base>
<path value="MedicinalProductDefinition"/>
<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>
<mustSupport value="false"/>
<isModifier value="false"/>
<isSummary value="false"/>
<mapping>
<identity value="rim"/>
<map
value="Entity, Role, or Act,ManufacturedProduct[classCode='MANU'].manufacturedProduct[classCode='MMAT']"/>
</mapping>
<mapping>
<identity value="w5"/>
<map value="administrative.medication"/>
</mapping>
<mapping>
<identity value="idmp"/>
<map value="Medicinal Product and Investigational Medicinal Product"/>
</mapping>
</element>
<element id="MedicinalProductDefinition.id">
<path value="MedicinalProductDefinition.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="MedicinalProductDefinition.meta">
<path value="MedicinalProductDefinition.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() > id.count())"/>
<source value="http://hl7.org/fhir/StructureDefinition/Element"/>
</constraint>
<mustSupport value="false"/>
<isModifier value="false"/>
<isSummary value="true"/>
</element>
<element id="MedicinalProductDefinition.implicitRules">
<path value="MedicinalProductDefinition.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() > 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="MedicinalProductDefinition.language">
<path value="MedicinalProductDefinition.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() > 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="MedicinalProductDefinition.text">
<path value="MedicinalProductDefinition.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 "clinically safe" 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 "text blob" 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() > 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="MedicinalProductDefinition.contained">
<path value="MedicinalProductDefinition.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="MedicinalProductDefinition.extension">
<path value="MedicinalProductDefinition.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() > 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="MedicinalProductDefinition.modifierExtension">
<path value="MedicinalProductDefinition.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() > 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="MedicinalProductDefinition.identifier">
<path value="MedicinalProductDefinition.identifier"/>
<slicing>
<discriminator>
<type value="pattern"/>
<path value="system"/>
</discriminator>
<rules value="open"/>
</slicing>
<short
value="Identifier for the medicinal product: MPID, EMA PMS ID, national ID, or other"/>
<definition
value="EMA IG 1.2 & 1.3. Identifier for the medicinal product: MPID, EMA PMS ID, national ID, or other. Not to be used for package or pharmaceutical product identifiers."/>
<alias value="MPID"/>
<min value="0"/>
<max value="*"/>
<base>
<path value="MedicinalProductDefinition.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() > id.count())"/>
<source value="http://hl7.org/fhir/StructureDefinition/Element"/>
</constraint>
<mustSupport value="false"/>
<isModifier value="false"/>
<isSummary value="true"/>
<mapping>
<identity value="w5"/>
<map value="FiveWs.class"/>
</mapping>
<mapping>
<identity value="idmp"/>
<map
value="Medicinal Product.MPID, Investigational Medicinal Product.IMPID"/>
</mapping>
<mapping>
<identity value="rim"/>
<map
value="ManufacturedProduct[classCode='MANU'].manufacturedProduct[classCode='MMAT'].code"/>
</mapping>
</element>
<element id="MedicinalProductDefinition.identifier:mpid">
<path value="MedicinalProductDefinition.identifier"/>
<sliceName value="mpid"/>
<short value="MPID"/>
<definition
value="EMA IG 1.2. MPID if exists. For UNICOM testing data fake MPIDs are used (Country code + MAH LocID + unique code). "/>
<alias value="MPID"/>
<min value="0"/>
<max value="1"/>
<base>
<path value="MedicinalProductDefinition.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() > id.count())"/>
<source value="http://hl7.org/fhir/StructureDefinition/Element"/>
</constraint>
<mustSupport value="false"/>
<isModifier value="false"/>
<isSummary value="true"/>
<mapping>
<identity value="w5"/>
<map value="FiveWs.class"/>
</mapping>
<mapping>
<identity value="idmp"/>
<map
value="Medicinal Product.MPID, Investigational Medicinal Product.IMPID"/>
</mapping>
<mapping>
<identity value="rim"/>
<map
value="ManufacturedProduct[classCode='MANU'].manufacturedProduct[classCode='MMAT'].code"/>
</mapping>
</element>
<element id="MedicinalProductDefinition.identifier:mpid.id">
<path value="MedicinalProductDefinition.identifier.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="MedicinalProductDefinition.identifier:mpid.extension">
<path value="MedicinalProductDefinition.identifier.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() > 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="MedicinalProductDefinition.identifier:mpid.use">
<path value="MedicinalProductDefinition.identifier.use"/>
<short value="usual | official | temp | secondary | old (If known)"/>
<definition value="The purpose of this identifier."/>
<comment
value="Applications can assume that an identifier is permanent unless it explicitly says that it is temporary."/>
<requirements
value="Allows the appropriate identifier for a particular context of use to be selected from among a set of identifiers."/>
<min value="0"/>
<max value="1"/>
<base>
<path value="Identifier.use"/>
<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() > id.count())"/>
<source value="http://hl7.org/fhir/StructureDefinition/Element"/>
</constraint>
<isModifier value="true"/>
<isModifierReason
value="This is labeled as "Is Modifier" because applications should not mistake a temporary id for a permanent one."/>
<isSummary value="true"/>
<binding>
<extension
url="http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName">
<valueString value="IdentifierUse"/>
</extension>
<strength value="required"/>
<description
value="Identifies the purpose for this identifier, if known ."/>
<valueSet value="http://hl7.org/fhir/ValueSet/identifier-use|5.0.0"/>
</binding>
<mapping>
<identity value="v2"/>
<map value="N/A"/>
</mapping>
<mapping>
<identity value="rim"/>
<map value="Role.code or implied by context"/>
</mapping>
</element>
<element id="MedicinalProductDefinition.identifier:mpid.type">
<path value="MedicinalProductDefinition.identifier.type"/>
<short value="Description of identifier"/>
<definition
value="A coded type for the identifier that can be used to determine which identifier to use for a specific purpose."/>
<comment
value="This element deals only with general categories of identifiers. It SHOULD not be used for codes that correspond 1..1 with the Identifier.system. Some identifiers may fall into multiple categories due to common usage. Where the system is known, a type is unnecessary because the type is always part of the system definition. However systems often need to handle identifiers where the system is not known. There is not a 1:1 relationship between type and system, since many different systems have the same type."/>
<requirements
value="Allows users to make use of identifiers when the identifier system is not known."/>
<min value="0"/>
<max value="1"/>
<base>
<path value="Identifier.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() > id.count())"/>
<source value="http://hl7.org/fhir/StructureDefinition/Element"/>
</constraint>
<isModifier value="false"/>
<isSummary value="true"/>
<binding>
<extension
url="http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName">
<valueString value="IdentifierType"/>
</extension>
<strength value="extensible"/>
<description
value="A coded type for an identifier that can be used to determine which identifier to use for a specific purpose."/>
<valueSet value="http://hl7.org/fhir/ValueSet/identifier-type"/>
</binding>
<mapping>
<identity value="v2"/>
<map value="CX.5"/>
</mapping>
<mapping>
<identity value="rim"/>
<map value="Role.code or implied by context"/>
</mapping>
</element>
<element id="MedicinalProductDefinition.identifier:mpid.system">
<path value="MedicinalProductDefinition.identifier.system"/>
<short value="The namespace for the identifier value"/>
<definition
value="Establishes the namespace for the value - that is, an absolute URL that describes a set values that are unique."/>
<comment value="Identifier.system is always case sensitive."/>
<requirements
value="There are many sets of identifiers. To perform matching of two identifiers, we need to know what set we're dealing with. The system identifies a particular set of unique identifiers."/>
<min value="1"/>
<max value="1"/>
<base>
<path value="Identifier.system"/>
<min value="0"/>
<max value="1"/>
</base>
<type>
<code value="uri"/>
</type>
<patternUri value="http://ema.europa.eu/fhir/mpId"/>
<example>
<label value="General"/>
<valueUri value="http://www.acme.com/identifiers/patient"/>
</example>
<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() > id.count())"/>
<source value="http://hl7.org/fhir/StructureDefinition/Element"/>
</constraint>
<isModifier value="false"/>
<isSummary value="true"/>
<mapping>
<identity value="v2"/>
<map value="CX.4 / EI-2-4"/>
</mapping>
<mapping>
<identity value="rim"/>
<map value="II.root or Role.id.root"/>
</mapping>
<mapping>
<identity value="servd"/>
<map value="./IdentifierType"/>
</mapping>
</element>
<element id="MedicinalProductDefinition.identifier:mpid.value">
<path value="MedicinalProductDefinition.identifier.value"/>
<short value="The value that is unique"/>
<definition
value="The portion of the identifier typically relevant to the user and which is unique within the context of the system."/>
<comment
value="If the value is a full URI, then the system SHALL be urn:ietf:rfc:3986. The value's primary purpose is computational mapping. As a result, it may be normalized for comparison purposes (e.g. removing non-significant whitespace, dashes, etc.) A value formatted for human display can be conveyed using the [http://hl7.org/fhir/StructureDefinition/rendered-value](http://hl7.org/fhir/extensions/StructureDefinition-rendered-value.html)). Identifier.value is to be treated as case sensitive unless knowledge of the Identifier.system allows the processer to be confident that non-case-sensitive processing is safe."/>
<min value="0"/>
<max value="1"/>
<base>
<path value="Identifier.value"/>
<min value="0"/>
<max value="1"/>
</base>
<type>
<code value="string"/>
</type>
<example>
<label value="General"/>
<valueString value="123456"/>
</example>
<condition value="ident-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() > id.count())"/>
<source value="http://hl7.org/fhir/StructureDefinition/Element"/>
</constraint>
<isModifier value="false"/>
<isSummary value="true"/>
<mapping>
<identity value="v2"/>
<map value="CX.1 / EI.1"/>
</mapping>
<mapping>
<identity value="rim"/>
<map
value="II.extension or II.root if system indicates OID or GUID (Or Role.id.extension or root)"/>
</mapping>
<mapping>
<identity value="servd"/>
<map value="./Value"/>
</mapping>
</element>
<element id="MedicinalProductDefinition.identifier:mpid.period">
<path value="MedicinalProductDefinition.identifier.period"/>
<short value="Time period when id is/was valid for use"/>
<definition
value="Time period during which identifier is/was valid for use."/>
<min value="0"/>
<max value="1"/>
<base>
<path value="Identifier.period"/>
<min value="0"/>
<max value="1"/>
</base>
<type>
<code value="Period"/>
</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() > id.count())"/>
<source value="http://hl7.org/fhir/StructureDefinition/Element"/>
</constraint>
<isModifier value="false"/>
<isSummary value="true"/>
<mapping>
<identity value="v2"/>
<map value="CX.7 + CX.8"/>
</mapping>
<mapping>
<identity value="rim"/>
<map value="Role.effectiveTime or implied by context"/>
</mapping>
<mapping>
<identity value="servd"/>
<map value="./StartDate and ./EndDate"/>
</mapping>
</element>
<element id="MedicinalProductDefinition.identifier:mpid.assigner">
<path value="MedicinalProductDefinition.identifier.assigner"/>
<short value="Organization that issued id (may be just text)"/>
<definition value="Organization that issued/manages the identifier."/>
<comment
value="The Identifier.assigner may omit the .reference element and only contain a .display element reflecting the name or other textual information about the assigning organization."/>
<min value="0"/>
<max value="1"/>
<base>
<path value="Identifier.assigner"/>
<min value="0"/>
<max value="1"/>
</base>
<type>
<code value="Reference"/>
<targetProfile
value="http://hl7.org/fhir/StructureDefinition/Organization"/>
</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() > id.count())"/>
<source value="http://hl7.org/fhir/StructureDefinition/Element"/>
</constraint>
<isModifier value="false"/>
<isSummary value="true"/>
<mapping>
<identity value="v2"/>
<map value="CX.4 / (CX.4,CX.9,CX.10)"/>
</mapping>
<mapping>
<identity value="rim"/>
<map
value="II.assigningAuthorityName but note that this is an improper use by the definition of the field. Also Role.scoper"/>
</mapping>
<mapping>
<identity value="servd"/>
<map value="./IdentifierIssuingAuthority"/>
</mapping>
</element>
<element id="MedicinalProductDefinition.identifier:pmsid">
<path value="MedicinalProductDefinition.identifier"/>
<sliceName value="pmsid"/>
<short value="PMS ID"/>
<definition
value="EMA IG 1.1. EMA Product Management System identifier if exists. For UNICOM testing data fake PMS IDs can be used"/>
<alias value="MPID"/>
<min value="0"/>
<max value="1"/>
<base>
<path value="MedicinalProductDefinition.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() > id.count())"/>
<source value="http://hl7.org/fhir/StructureDefinition/Element"/>
</constraint>
<mustSupport value="false"/>
<isModifier value="false"/>
<isSummary value="true"/>
<mapping>
<identity value="w5"/>
<map value="FiveWs.class"/>
</mapping>
<mapping>
<identity value="idmp"/>
<map
value="Medicinal Product.MPID, Investigational Medicinal Product.IMPID"/>
</mapping>
<mapping>
<identity value="rim"/>
<map
value="ManufacturedProduct[classCode='MANU'].manufacturedProduct[classCode='MMAT'].code"/>
</mapping>
</element>
<element id="MedicinalProductDefinition.identifier:pmsid.id">
<path value="MedicinalProductDefinition.identifier.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="MedicinalProductDefinition.identifier:pmsid.extension">
<path value="MedicinalProductDefinition.identifier.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() > 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="MedicinalProductDefinition.identifier:pmsid.use">
<path value="MedicinalProductDefinition.identifier.use"/>
<short value="usual | official | temp | secondary | old (If known)"/>
<definition value="The purpose of this identifier."/>
<comment
value="Applications can assume that an identifier is permanent unless it explicitly says that it is temporary."/>
<requirements
value="Allows the appropriate identifier for a particular context of use to be selected from among a set of identifiers."/>
<min value="0"/>
<max value="1"/>
<base>
<path value="Identifier.use"/>
<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() > id.count())"/>
<source value="http://hl7.org/fhir/StructureDefinition/Element"/>
</constraint>
<isModifier value="true"/>
<isModifierReason
value="This is labeled as "Is Modifier" because applications should not mistake a temporary id for a permanent one."/>
<isSummary value="true"/>
<binding>
<extension
url="http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName">
<valueString value="IdentifierUse"/>
</extension>
<strength value="required"/>
<description
value="Identifies the purpose for this identifier, if known ."/>
<valueSet value="http://hl7.org/fhir/ValueSet/identifier-use|5.0.0"/>
</binding>
<mapping>
<identity value="v2"/>
<map value="N/A"/>
</mapping>
<mapping>
<identity value="rim"/>
<map value="Role.code or implied by context"/>
</mapping>
</element>
<element id="MedicinalProductDefinition.identifier:pmsid.type">
<path value="MedicinalProductDefinition.identifier.type"/>
<short value="Description of identifier"/>
<definition
value="A coded type for the identifier that can be used to determine which identifier to use for a specific purpose."/>
<comment
value="This element deals only with general categories of identifiers. It SHOULD not be used for codes that correspond 1..1 with the Identifier.system. Some identifiers may fall into multiple categories due to common usage. Where the system is known, a type is unnecessary because the type is always part of the system definition. However systems often need to handle identifiers where the system is not known. There is not a 1:1 relationship between type and system, since many different systems have the same type."/>
<requirements
value="Allows users to make use of identifiers when the identifier system is not known."/>
<min value="0"/>
<max value="1"/>
<base>
<path value="Identifier.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() > id.count())"/>
<source value="http://hl7.org/fhir/StructureDefinition/Element"/>
</constraint>
<isModifier value="false"/>
<isSummary value="true"/>
<binding>
<extension
url="http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName">
<valueString value="IdentifierType"/>
</extension>
<strength value="extensible"/>
<description
value="A coded type for an identifier that can be used to determine which identifier to use for a specific purpose."/>
<valueSet value="http://hl7.org/fhir/ValueSet/identifier-type"/>
</binding>
<mapping>
<identity value="v2"/>
<map value="CX.5"/>
</mapping>
<mapping>
<identity value="rim"/>
<map value="Role.code or implied by context"/>
</mapping>
</element>
<element id="MedicinalProductDefinition.identifier:pmsid.system">
<path value="MedicinalProductDefinition.identifier.system"/>
<short value="The namespace for the identifier value"/>
<definition
value="Establishes the namespace for the value - that is, an absolute URL that describes a set values that are unique."/>
<comment value="Identifier.system is always case sensitive."/>
<requirements
value="There are many sets of identifiers. To perform matching of two identifiers, we need to know what set we're dealing with. The system identifies a particular set of unique identifiers."/>
<min value="1"/>
<max value="1"/>
<base>
<path value="Identifier.system"/>
<min value="0"/>
<max value="1"/>
</base>
<type>
<code value="uri"/>
</type>
<patternUri value="http://ema.europa.eu/fhir/pmsId"/>
<example>
<label value="General"/>
<valueUri value="http://www.acme.com/identifiers/patient"/>
</example>
<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() > id.count())"/>
<source value="http://hl7.org/fhir/StructureDefinition/Element"/>
</constraint>
<isModifier value="false"/>
<isSummary value="true"/>
<mapping>
<identity value="v2"/>
<map value="CX.4 / EI-2-4"/>
</mapping>
<mapping>
<identity value="rim"/>
<map value="II.root or Role.id.root"/>
</mapping>
<mapping>
<identity value="servd"/>
<map value="./IdentifierType"/>
</mapping>
</element>
<element id="MedicinalProductDefinition.identifier:pmsid.value">
<path value="MedicinalProductDefinition.identifier.value"/>
<short value="The value that is unique"/>
<definition
value="The portion of the identifier typically relevant to the user and which is unique within the context of the system."/>
<comment
value="If the value is a full URI, then the system SHALL be urn:ietf:rfc:3986. The value's primary purpose is computational mapping. As a result, it may be normalized for comparison purposes (e.g. removing non-significant whitespace, dashes, etc.) A value formatted for human display can be conveyed using the [http://hl7.org/fhir/StructureDefinition/rendered-value](http://hl7.org/fhir/extensions/StructureDefinition-rendered-value.html)). Identifier.value is to be treated as case sensitive unless knowledge of the Identifier.system allows the processer to be confident that non-case-sensitive processing is safe."/>
<min value="0"/>
<max value="1"/>
<base>
<path value="Identifier.value"/>
<min value="0"/>
<max value="1"/>
</base>
<type>
<code value="string"/>
</type>
<example>
<label value="General"/>
<valueString value="123456"/>
</example>
<condition value="ident-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() > id.count())"/>
<source value="http://hl7.org/fhir/StructureDefinition/Element"/>
</constraint>
<isModifier value="false"/>
<isSummary value="true"/>
<mapping>
<identity value="v2"/>
<map value="CX.1 / EI.1"/>
</mapping>
<mapping>
<identity value="rim"/>
<map
value="II.extension or II.root if system indicates OID or GUID (Or Role.id.extension or root)"/>
</mapping>
<mapping>
<identity value="servd"/>
<map value="./Value"/>
</mapping>
</element>
<element id="MedicinalProductDefinition.identifier:pmsid.period">
<path value="MedicinalProductDefinition.identifier.period"/>
<short value="Time period when id is/was valid for use"/>
<definition
value="Time period during which identifier is/was valid for use."/>
<min value="0"/>
<max value="1"/>
<base>
<path value="Identifier.period"/>
<min value="0"/>
<max value="1"/>
</base>
<type>
<code value="Period"/>
</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() > id.count())"/>
<source value="http://hl7.org/fhir/StructureDefinition/Element"/>
</constraint>
<isModifier value="false"/>
<isSummary value="true"/>
<mapping>
<identity value="v2"/>
<map value="CX.7 + CX.8"/>
</mapping>
<mapping>
<identity value="rim"/>
<map value="Role.effectiveTime or implied by context"/>
</mapping>
<mapping>
<identity value="servd"/>
<map value="./StartDate and ./EndDate"/>
</mapping>
</element>
<element id="MedicinalProductDefinition.identifier:pmsid.assigner">
<path value="MedicinalProductDefinition.identifier.assigner"/>
<short value="Organization that issued id (may be just text)"/>
<definition value="Organization that issued/manages the identifier."/>
<comment
value="The Identifier.assigner may omit the .reference element and only contain a .display element reflecting the name or other textual information about the assigning organization."/>
<min value="0"/>
<max value="1"/>
<base>
<path value="Identifier.assigner"/>
<min value="0"/>
<max value="1"/>
</base>
<type>
<code value="Reference"/>
<targetProfile
value="http://hl7.org/fhir/StructureDefinition/Organization"/>
</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() > id.count())"/>
<source value="http://hl7.org/fhir/StructureDefinition/Element"/>
</constraint>
<isModifier value="false"/>
<isSummary value="true"/>
<mapping>
<identity value="v2"/>
<map value="CX.4 / (CX.4,CX.9,CX.10)"/>
</mapping>
<mapping>
<identity value="rim"/>
<map
value="II.assigningAuthorityName but note that this is an improper use by the definition of the field. Also Role.scoper"/>
</mapping>
<mapping>
<identity value="servd"/>
<map value="./IdentifierIssuingAuthority"/>
</mapping>
</element>
<element id="MedicinalProductDefinition.type">
<path value="MedicinalProductDefinition.type"/>
<short value="Regulatory type, e.g. Investigational or Authorized"/>
<definition
value="Regulatory type, e.g. Investigational or Authorized."/>
<min value="0"/>
<max value="1"/>
<base>
<path value="MedicinalProductDefinition.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() > 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="Overall defining type of this medicinal product."/>
<valueSet
value="http://hl7.org/fhir/ValueSet/medicinal-product-type"/>
</binding>
<mapping>
<identity value="idmp"/>
<map
value="(indicates if this is Medicinal Product or an Investigational Medicinal Product)"/>
</mapping>
<mapping>
<identity value="rim"/>
<map
value="ManufacturedProduct[classCode='MANU'].manufacturedProduct.asSpecializedKind.generalizedMaterialKind.code"/>
</mapping>
</element>
<element id="MedicinalProductDefinition.domain">
<path value="MedicinalProductDefinition.domain"/>
<short value="If this medicine applies to human or veterinary uses"/>
<definition value="EMA IG 1.3"/>
<min value="0"/>
<max value="1"/>
<base>
<path value="MedicinalProductDefinition.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() > 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://unicom-project.eu/fhir/d4-12/ValueSet/domain-vs"/>
</binding>
<mapping>
<identity value="idmp"/>
<map value="n/a"/>
</mapping>
<mapping>
<identity value="rim"/>
<map
value="ManufacturedProduct[classCode='MANU'].subjectOf.characteristic[@code='{domain}'].value"/>
</mapping>
</element>
<element id="MedicinalProductDefinition.version">
<path value="MedicinalProductDefinition.version"/>
<short
value="A business identifier relating to a specific version of the product"/>
<definition
value="A business identifier relating to a specific version of the product, this is commonly used to support revisions to an existing product."/>
<min value="0"/>
<max value="1"/>
<base>
<path value="MedicinalProductDefinition.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() > id.count())"/>
<source value="http://hl7.org/fhir/StructureDefinition/Element"/>
</constraint>
<mustSupport value="false"/>
<isModifier value="false"/>
<isSummary value="true"/>
<mapping>
<identity value="idmp"/>
<map value="Medicinal Product.Header.Version Number"/>
</mapping>
<mapping>
<identity value="rim"/>
<map value="n/a"/>
</mapping>
</element>
<element id="MedicinalProductDefinition.status">
<path value="MedicinalProductDefinition.status"/>
<short
value="Status of the product's data. Default 200000005004 'Current'"/>
<definition
value="The status within the lifecycle of this product record. A high-level status, this is not intended to duplicate details carried elsewhere such as legal status, or authorization status."/>
<min value="0"/>
<max value="1"/>
<base>
<path value="MedicinalProductDefinition.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() > id.count())"/>
<source value="http://hl7.org/fhir/StructureDefinition/Element"/>
</constraint>
<mustSupport value="false"/>
<isModifier value="true"/>
<isModifierReason
value="This element is labelled as a modifier because it is a status element that can indicate that a record should not be treated as valid"/>
<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"/>
<map value="n/a"/>
</mapping>
<mapping>
<identity value="rim"/>
<map value="n/a"/>
</mapping>
</element>
<element id="MedicinalProductDefinition.statusDate">
<path value="MedicinalProductDefinition.statusDate"/>
<short value="The date at which the given status became applicable"/>
<definition
value="The date at which the given status became applicable."/>
<min value="0"/>
<max value="1"/>
<base>
<path value="MedicinalProductDefinition.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() > id.count())"/>
<source value="http://hl7.org/fhir/StructureDefinition/Element"/>
</constraint>
<mustSupport value="false"/>
<isModifier value="false"/>
<isSummary value="true"/>
<mapping>
<identity value="idmp"/>
<map value="n/a"/>
</mapping>
<mapping>
<identity value="rim"/>
<map value="n/a"/>
</mapping>
</element>
<element id="MedicinalProductDefinition.description">
<path value="MedicinalProductDefinition.description"/>
<short value="General description of this product"/>
<definition value="General description of this product."/>
<min value="0"/>
<max value="1"/>
<base>
<path value="MedicinalProductDefinition.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() > id.count())"/>
<source value="http://hl7.org/fhir/StructureDefinition/Element"/>
</constraint>
<mustSupport value="false"/>
<isModifier value="false"/>
<isSummary value="true"/>
<mapping>
<identity value="idmp"/>
<map value="n/a"/>
</mapping>
<mapping>
<identity value="rim"/>
<map
value="ManufacturedProduct[classCode='MANU'].manufacturedProduct[classCode='MMAT'].desc"/>
</mapping>
</element>
<element id="MedicinalProductDefinition.combinedPharmaceuticalDoseForm">
<path
value="MedicinalProductDefinition.combinedPharmaceuticalDoseForm"/>
<short
value="Authorised dose form for the product, incl combination package dose forms"/>
<definition
value="EMA IG 1.5 & 1.6. Authorised dose form for the whole product. As applicable in one of the SPOR RMS list Combined pharmaceutical dose form, Pharmaceutical dose form, Combined term, Combination Package"/>
<min value="0"/>
<max value="1"/>
<base>
<path
value="MedicinalProductDefinition.combinedPharmaceuticalDoseForm"/>
<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() > 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://unicom-project.eu/fhir/d4-12/ValueSet/authorised-doseform-vs"/>
</binding>
<mapping>
<identity value="idmp"/>
<map value="Medicinal Product.Combined Pharmaceutical Dose Form"/>
</mapping>
<mapping>
<identity value="rim"/>
<map
value="ManufacturedProduct[classCode='MANU'].manufacturedProduct[classCode='MMAT'].formCode"/>
</mapping>
</element>
<element id="MedicinalProductDefinition.route">
<path value="MedicinalProductDefinition.route"/>
<short
value="The path by which the product is taken into or makes contact with the body"/>
<definition
value="The path by which the product is taken into or makes contact with the body. In some regions this is referred to as the licenced or approved route. See also AdministrableProductDefinition resource. MedicinalProductDefinition.route is the same concept as AdministrableProductDefinition.routeOfAdministration.code, and they cannot be used together."/>
<min value="0"/>
<max value="*"/>
<base>
<path value="MedicinalProductDefinition.route"/>
<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() > 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="SNOMEDCTRouteCodes"/>
</extension>
<strength value="example"/>
<description
value="A code specifying the route or physiological path of administration of a therapeutic agent into or onto a patient's body."/>
<valueSet value="http://hl7.org/fhir/ValueSet/route-codes"/>
</binding>
<mapping>
<identity value="idmp"/>
<map value="Pharmaceutical Product.Route of Administration"/>
</mapping>
<mapping>
<identity value="rim"/>
<map
value="ManufacturedProduct[classCode='MANU'].productOf.reconstitution.consumable.administerableMaterial.consumedIn.substanceAdministration1.routeCode"/>
</mapping>
</element>
<element id="MedicinalProductDefinition.indication">
<path value="MedicinalProductDefinition.indication"/>
<short
value="Description of indication(s) for this product, used when structured indications are not required"/>
<definition
value="Description of indication(s) for this product, used when structured indications are not required. In cases where structured indications are required, they are captured using the ClinicalUseDefinition resource. An indication is a medical situation for which using the product is appropriate."/>
<min value="0"/>
<max value="1"/>
<base>
<path value="MedicinalProductDefinition.indication"/>
<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() > id.count())"/>
<source value="http://hl7.org/fhir/StructureDefinition/Element"/>
</constraint>
<mustSupport value="false"/>
<isModifier value="false"/>
<isSummary value="true"/>
<mapping>
<identity value="idmp"/>
<map
value="(roll up of all text in Therapeutic Indication.Indication Text, for common case where information is not granular)"/>
</mapping>
<mapping>
<identity value="rim"/>
<map
value="ManufacturedProduct[classCode='MANU'].consumedIn.substanceAdministration1.reason.indicationObservationCriterion[@code='{Observation_MedicalProblem}'].value.originalText.@value"/>
</mapping>
</element>
<element id="MedicinalProductDefinition.legalStatusOfSupply">
<path value="MedicinalProductDefinition.legalStatusOfSupply"/>
<short value="Legal status of supply on the medicinal product level."/>
<definition
value="EMA IG 1.7. Legal status of supply on the medicinal product level. The same information can be repeated/differentiated on the package level"/>
<min value="0"/>
<max value="1"/>
<base>
<path value="MedicinalProductDefinition.legalStatusOfSupply"/>
<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() > 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://unicom-project.eu/fhir/d4-12/ValueSet/legal-status-for-the-supply-vs"/>
</binding>
<mapping>
<identity value="idmp"/>
<map
value="Marketing Authorisation.Legal Status of Supply (moved here for practicality)"/>
</mapping>
<mapping>
<identity value="rim"/>
<map
value="ManufacturedProduct[classCode='MANU'].subjectOf.approval[@code='{Approval_MarketingAuthorization}'].pertinentInformation.policy.code"/>
</mapping>
</element>
<element id="MedicinalProductDefinition.additionalMonitoringIndicator">
<path value="MedicinalProductDefinition.additionalMonitoringIndicator"/>
<short
value="Whether the Medicinal Product is subject to additional monitoring for regulatory reasons"/>
<definition
value="Whether the Medicinal Product is subject to additional monitoring for regulatory reasons, such as heightened reporting requirements."/>
<min value="0"/>
<max value="1"/>
<base>
<path
value="MedicinalProductDefinition.additionalMonitoringIndicator"/>
<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() > 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="AdditionalMonitoring"/>
</extension>
<strength value="example"/>
<description
value="Extra measures defined for a Medicinal Product, such as heightened reporting requirements (e.g. Black Triangle Monitoring)."/>
<valueSet
value="http://hl7.org/fhir/ValueSet/medicinal-product-additional-monitoring"/>
</binding>
<mapping>
<identity value="idmp"/>
<map value="Medicinal Product.Additional Monitoring Indicator"/>
</mapping>
<mapping>
<identity value="rim"/>
<map
value="ManufacturedProduct[classCode='MANU'].subjectOf.policy.code"/>
</mapping>
</element>
<element id="MedicinalProductDefinition.specialMeasures">
<path value="MedicinalProductDefinition.specialMeasures"/>
<short
value="Whether the Medicinal Product is subject to special measures for regulatory reasons"/>
<definition
value="Whether the Medicinal Product is subject to special measures for regulatory reasons, such as a requirement to conduct post-authorization studies."/>
<min value="0"/>
<max value="*"/>
<base>
<path value="MedicinalProductDefinition.specialMeasures"/>
<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() > 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="SpecialMeasures"/>
</extension>
<strength value="example"/>
<description
value="Extra measures defined for a Medicinal Product, such as a requirement to conduct post-authorization studies."/>
<valueSet
value="http://hl7.org/fhir/ValueSet/medicinal-product-special-measures"/>
</binding>
<mapping>
<identity value="idmp"/>
<map value="Medicinal Product.Special Measures"/>
</mapping>
<mapping>
<identity value="rim"/>
<map
value="ManufacturedProduct[classCode='MANU'].subjectOf.policy.code[@nullFlavor='OTH'].displayName"/>
</mapping>
</element>
<element id="MedicinalProductDefinition.pediatricUseIndicator">
<path value="MedicinalProductDefinition.pediatricUseIndicator"/>
<short value="If authorised for use in children"/>
<definition
value="If authorised for use in children, or infants, neonates etc."/>
<min value="0"/>
<max value="1"/>
<base>
<path value="MedicinalProductDefinition.pediatricUseIndicator"/>
<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() > 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="PediatricUse"/>
</extension>
<strength value="example"/>
<description
value="Suitability for age groups, in particular children."/>
<valueSet
value="http://hl7.org/fhir/ValueSet/medicinal-product-pediatric-use"/>
</binding>
<mapping>
<identity value="idmp"/>
<map value="Medicinal Product.Pediatric Use Indicator"/>
</mapping>
<mapping>
<identity value="rim"/>
<map
value="ManufacturedProduct[classCode='MANU'].subjectOf.policy.code"/>
</mapping>
</element>
<element id="MedicinalProductDefinition.classification">
<path value="MedicinalProductDefinition.classification"/>
<slicing>
<discriminator>
<type value="pattern"/>
<path value="coding.system"/>
</discriminator>
<rules value="open"/>
</slicing>
<short value="ATC or other classification"/>
<definition value="EMA IG 1.13"/>
<min value="0"/>
<max value="*"/>
<base>
<path value="MedicinalProductDefinition.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() > 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="ProductClassification"/>
</extension>
<strength value="example"/>
<description
value="This value set includes codes from the Anatomical Therapeutic Chemical Classification System - provided as an exemplar value set."/>
<valueSet
value="http://hl7.org/fhir/ValueSet/medicinal-product-classification"/>
</binding>
<mapping>
<identity value="idmp"/>
<map value="Product Classification.Value"/>
</mapping>
<mapping>
<identity value="rim"/>
<map
value="ManufacturedProduct[classCode='MANU'].manufacturedProduct/asSpecializedKind/generalizedMaterialKind/code"/>
</mapping>
</element>
<element id="MedicinalProductDefinition.classification:atc">
<path value="MedicinalProductDefinition.classification"/>
<sliceName value="atc"/>
<short value="Allows the product to be classified by various systems"/>
<definition
value="Allows the product to be classified by various systems, commonly WHO ATC."/>
<min value="0"/>
<max value="*"/>
<base>
<path value="MedicinalProductDefinition.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() > 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="ProductClassification"/>
</extension>
<strength value="example"/>
<description
value="This value set includes codes from the Anatomical Therapeutic Chemical Classification System - provided as an exemplar value set."/>
<valueSet
value="http://hl7.org/fhir/ValueSet/medicinal-product-classification"/>
</binding>
<mapping>
<identity value="idmp"/>
<map value="Product Classification.Value"/>
</mapping>
<mapping>
<identity value="rim"/>
<map
value="ManufacturedProduct[classCode='MANU'].manufacturedProduct/asSpecializedKind/generalizedMaterialKind/code"/>
</mapping>
</element>
<element id="MedicinalProductDefinition.classification:atc.id">
<path value="MedicinalProductDefinition.classification.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="MedicinalProductDefinition.classification:atc.extension">
<path value="MedicinalProductDefinition.classification.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() > 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="MedicinalProductDefinition.classification:atc.coding">
<path value="MedicinalProductDefinition.classification.coding"/>
<slicing>
<discriminator>
<type value="pattern"/>
<path value="system"/>
</discriminator>
<rules value="open"/>
</slicing>
<short value="ATC classification"/>
<definition value="EMA IG 1.13.3"/>
<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="0"/>
<max value="*"/>
<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() > 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.1-8, 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="MedicinalProductDefinition.classification:atc.coding:ema">
<path value="MedicinalProductDefinition.classification.coding"/>
<sliceName value="ema"/>
<short value="ATC classification as EMA SPOR code"/>
<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="0"/>
<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() > 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.1-8, 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="MedicinalProductDefinition.classification:atc.coding:ema.id">
<path value="MedicinalProductDefinition.classification.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="MedicinalProductDefinition.classification:atc.coding:ema.extension">
<path
value="MedicinalProductDefinition.classification.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() > 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="MedicinalProductDefinition.classification:atc.coding:ema.system">
<path value="MedicinalProductDefinition.classification.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="https://spor.ema.europa.eu/v1/lists/100000093533"/>
<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() > 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.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="MedicinalProductDefinition.classification:atc.coding:ema.version">
<path value="MedicinalProductDefinition.classification.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() > 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="MedicinalProductDefinition.classification:atc.coding:ema.code">
<path value="MedicinalProductDefinition.classification.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() > 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="MedicinalProductDefinition.classification:atc.coding:ema.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="MedicinalProductDefinition.classification.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() > 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="MedicinalProductDefinition.classification:atc.coding:ema.userSelected">
<path
value="MedicinalProductDefinition.classification.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() > 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 "true"; fhir:target dt:CDCoding.codingRationale\#O ]"/>
</mapping>
</element>
<element id="MedicinalProductDefinition.classification:atc.coding:who">
<path value="MedicinalProductDefinition.classification.coding"/>
<sliceName value="who"/>
<short value="ATC classification as WHO ATC code"/>
<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="0"/>
<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() > 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.1-8, 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="MedicinalProductDefinition.classification:atc.coding:who.id">
<path value="MedicinalProductDefinition.classification.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="MedicinalProductDefinition.classification:atc.coding:who.extension">
<path
value="MedicinalProductDefinition.classification.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() > 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="MedicinalProductDefinition.classification:atc.coding:who.system">
<path value="MedicinalProductDefinition.classification.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://www.whocc.no/atc"/>
<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() > 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.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="MedicinalProductDefinition.classification:atc.coding:who.version">
<path value="MedicinalProductDefinition.classification.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() > 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="MedicinalProductDefinition.classification:atc.coding:who.code">
<path value="MedicinalProductDefinition.classification.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() > 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="MedicinalProductDefinition.classification:atc.coding:who.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="MedicinalProductDefinition.classification.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() > 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="MedicinalProductDefinition.classification:atc.coding:who.userSelected">
<path
value="MedicinalProductDefinition.classification.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() > 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 "true"; fhir:target dt:CDCoding.codingRationale\#O ]"/>
</mapping>
</element>
<element id="MedicinalProductDefinition.classification:atc.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="MedicinalProductDefinition.classification.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() > 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="text/plain"]/data"/>
</mapping>
<mapping>
<identity value="orim"/>
<map
value="fhir:CodeableConcept.text rdfs:subPropertyOf dt:CD.originalText"/>
</mapping>
</element>
<element id="MedicinalProductDefinition.marketingStatus">
<path value="MedicinalProductDefinition.marketingStatus"/>
<short
value="Marketing status of the medicinal product, in contrast to marketing authorization"/>
<definition
value="Marketing status of the medicinal product, in contrast to marketing authorization. This refers to the product being actually 'on the market' as opposed to being allowed to be on the market (which is an authorization)."/>
<min value="0"/>
<max value="*"/>
<base>
<path value="MedicinalProductDefinition.marketingStatus"/>
<min value="0"/>
<max value="*"/>
</base>
<type>
<code value="MarketingStatus"/>
</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() > id.count())"/>
<source value="http://hl7.org/fhir/StructureDefinition/Element"/>
</constraint>
<mustSupport value="false"/>
<isModifier value="false"/>
<isSummary value="true"/>
<mapping>
<identity value="idmp"/>
<map value="Marketing Status"/>
</mapping>
<mapping>
<identity value="rim"/>
<map
value="ManufacturedProduct[classCode='MANU'].subjectOf.approval[@code='{Approval_MarketingAuthorization}'].statusCode"/>
</mapping>
</element>
<element id="MedicinalProductDefinition.packagedMedicinalProduct">
<path value="MedicinalProductDefinition.packagedMedicinalProduct"/>
<short value="Package type for the product"/>
<definition
value="Package type for the product. See also the PackagedProductDefinition resource."/>
<min value="0"/>
<max value="*"/>
<base>
<path value="MedicinalProductDefinition.packagedMedicinalProduct"/>
<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() > 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="MedicinalProductPackageType"/>
</extension>
<strength value="example"/>
<description value="Types of medicinal product packs"/>
<valueSet
value="http://hl7.org/fhir/ValueSet/medicinal-product-package-type"/>
</binding>
<mapping>
<identity value="idmp"/>
<map value="Packaged Medicinal Product"/>
</mapping>
<mapping>
<identity value="rim"/>
<map
value="ManufacturedProduct[classCode='MANU'].manufacturedProduct.asContent.containerPackagedProduct.asContent.containerPackagedProduct.code"/>
</mapping>
</element>
<element id="MedicinalProductDefinition.comprisedOf">
<path value="MedicinalProductDefinition.comprisedOf"/>
<short
value="Types of medicinal manufactured items and/or devices that this product consists of, such as tablets, capsule, or syringes"/>
<definition
value="Types of medicinal manufactured items and/or devices that this product consists of, such as tablets, capsule, or syringes. Used as a direct link when the item's packaging is not being recorded (see also PackagedProductDefinition.package.containedItem.item)."/>
<min value="0"/>
<max value="*"/>
<base>
<path value="MedicinalProductDefinition.comprisedOf"/>
<min value="0"/>
<max value="*"/>
</base>
<type>
<code value="Reference"/>
<targetProfile
value="http://hl7.org/fhir/StructureDefinition/ManufacturedItemDefinition"/>
<targetProfile
value="http://hl7.org/fhir/StructureDefinition/DeviceDefinition"/>
</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() > id.count())"/>
<source value="http://hl7.org/fhir/StructureDefinition/Element"/>
</constraint>
<mustSupport value="false"/>
<isModifier value="false"/>
<isSummary value="true"/>
<mapping>
<identity value="idmp"/>
<map value="Manufactured Item"/>
</mapping>
<mapping>
<identity value="rim"/>
<map
value="ManufacturedProduct[classCode='MANU'].manufacturedProduct.formCode"/>
</mapping>
</element>
<element id="MedicinalProductDefinition.ingredient">
<path value="MedicinalProductDefinition.ingredient"/>
<short
value="The ingredients of this medicinal product - when not detailed in other resources"/>
<definition
value="The ingredients of this medicinal product - when not detailed in other resources. This is only needed if the ingredients are not specified by incoming references from the Ingredient resource, or indirectly via incoming AdministrableProductDefinition, PackagedProductDefinition or ManufacturedItemDefinition references. In cases where those levels of detail are not used, the ingredients may be specified directly here as codes."/>
<min value="0"/>
<max value="*"/>
<base>
<path value="MedicinalProductDefinition.ingredient"/>
<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() > 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="SNOMEDCTSubstanceCodes"/>
</extension>
<strength value="example"/>
<description
value="This value set includes all substance codes from SNOMED CT - provided as an exemplar value set."/>
<valueSet value="http://hl7.org/fhir/ValueSet/substance-codes"/>
</binding>
<mapping>
<identity value="idmp"/>
<map
value="Medicinal Product.Ingredient (see also FHIR Ingredient resource)"/>
</mapping>
<mapping>
<identity value="rim"/>
<map
value="ManufacturedProduct[classCode='MANU'].manufacturedProduct[classCode='MMAT'].ingredient.ingredientSubstance.code"/>
</mapping>
</element>
<element id="MedicinalProductDefinition.impurity">
<path value="MedicinalProductDefinition.impurity"/>
<short
value="Any component of the drug product which is not the chemical entity defined as the drug substance, or an excipient in the drug product"/>
<definition
value="Any component of the drug product which is not the chemical entity defined as the drug substance, or an excipient in the drug product. This includes process-related impurities and contaminants, product-related impurities including degradation products."/>
<min value="0"/>
<max value="*"/>
<base>
<path value="MedicinalProductDefinition.impurity"/>
<min value="0"/>
<max value="*"/>
</base>
<type>
<code value="CodeableReference"/>
<targetProfile
value="http://hl7.org/fhir/StructureDefinition/SubstanceDefinition"/>
</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() > 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="SNOMEDCTSubstanceCodes"/>
</extension>
<strength value="example"/>
<description
value="This value set includes all substance codes from SNOMED CT - provided as an exemplar value set."/>
<valueSet value="http://hl7.org/fhir/ValueSet/substance-codes"/>
</binding>
<mapping>
<identity value="idmp"/>
<map value="n/a"/>
</mapping>
<mapping>
<identity value="rim"/>
<map value="(to do)"/>
</mapping>
</element>
<element id="MedicinalProductDefinition.attachedDocument">
<path value="MedicinalProductDefinition.attachedDocument"/>
<short value="Additional documentation about the medicinal product"/>
<definition
value="Additional information or supporting documentation about the medicinal product."/>
<min value="0"/>
<max value="*"/>
<base>
<path value="MedicinalProductDefinition.attachedDocument"/>
<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() > id.count())"/>
<source value="http://hl7.org/fhir/StructureDefinition/Element"/>
</constraint>
<mustSupport value="false"/>
<isModifier value="false"/>
<isSummary value="true"/>
<mapping>
<identity value="idmp"/>
<map value="Attached Document"/>
</mapping>
<mapping>
<identity value="rim"/>
<map
value="ManufacturedProduct[classCode='MANU'].subjectOf.document"/>
</mapping>
</element>
<element id="MedicinalProductDefinition.masterFile">
<path value="MedicinalProductDefinition.masterFile"/>
<short
value="A master file for the medicinal product (e.g. Pharmacovigilance System Master File)"/>
<definition
value="A master file for the medicinal product (e.g. Pharmacovigilance System Master File). Drug master files (DMFs) are documents submitted to regulatory agencies to provide confidential detailed information about facilities, processes or articles used in the manufacturing, processing, packaging and storing of drug products."/>
<min value="0"/>
<max value="*"/>
<base>
<path value="MedicinalProductDefinition.masterFile"/>
<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() > id.count())"/>
<source value="http://hl7.org/fhir/StructureDefinition/Element"/>
</constraint>
<mustSupport value="false"/>
<isModifier value="false"/>
<isSummary value="true"/>
<mapping>
<identity value="idmp"/>
<map value="Master File"/>
</mapping>
<mapping>
<identity value="rim"/>
<map
value="ManufacturedProduct[classCode='MANU'].subjectOf.document"/>
</mapping>
</element>
<element id="MedicinalProductDefinition.contact">
<path value="MedicinalProductDefinition.contact"/>
<short
value="A product specific contact, person (in a role), or an organization"/>
<definition
value="A product specific contact, person (in a role), or an organization."/>
<min value="0"/>
<max value="*"/>
<base>
<path value="MedicinalProductDefinition.contact"/>
<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() > id.count())"/>
<source value="http://hl7.org/fhir/StructureDefinition/Element"/>
</constraint>
<mustSupport value="false"/>
<isModifier value="false"/>
<isSummary value="true"/>
<mapping>
<identity value="idmp"/>
<map value="n/a"/>
</mapping>
<mapping>
<identity value="rim"/>
<map
value="ManufacturedProduct[classCode='MANU'].subjectOf.assignedEntity.assignedOrganization.contactParty"/>
</mapping>
</element>
<element id="MedicinalProductDefinition.contact.id">
<path value="MedicinalProductDefinition.contact.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="MedicinalProductDefinition.contact.extension">
<path value="MedicinalProductDefinition.contact.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() > 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="MedicinalProductDefinition.contact.modifierExtension">
<path value="MedicinalProductDefinition.contact.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() > 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="MedicinalProductDefinition.contact.type">
<path value="MedicinalProductDefinition.contact.type"/>
<short
value="Allows the contact to be classified, for example QPPV, Pharmacovigilance Enquiry Information"/>
<definition
value="Allows the contact to be classified, for example QPPV, Pharmacovigilance Enquiry Information."/>
<min value="0"/>
<max value="1"/>
<base>
<path value="MedicinalProductDefinition.contact.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() > 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="ProductContactType"/>
</extension>
<strength value="example"/>
<description
value="Extra measures defined for a Medicinal Product, such as heightened reporting requirements."/>
<valueSet
value="http://hl7.org/fhir/ValueSet/medicinal-product-contact-type"/>
</binding>
<mapping>
<identity value="idmp"/>
<map value="n/a"/>
</mapping>
<mapping>
<identity value="rim"/>
<map
value="ManufacturedProduct[classCode='MANU'].subjectOf.assignedEntity.assignedOrganization.contactParty.code"/>
</mapping>
</element>
<element id="MedicinalProductDefinition.contact.contact">
<path value="MedicinalProductDefinition.contact.contact"/>
<short
value="A product specific contact, person (in a role), or an organization"/>
<definition
value="A product specific contact, person (in a role), or an organization."/>
<min value="1"/>
<max value="1"/>
<base>
<path value="MedicinalProductDefinition.contact.contact"/>
<min value="1"/>
<max value="1"/>
</base>
<type>
<code value="Reference"/>
<targetProfile
value="http://hl7.org/fhir/StructureDefinition/Organization"/>
<targetProfile
value="http://hl7.org/fhir/StructureDefinition/PractitionerRole"/>
</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() > id.count())"/>
<source value="http://hl7.org/fhir/StructureDefinition/Element"/>
</constraint>
<mustSupport value="false"/>
<isModifier value="false"/>
<isSummary value="true"/>
<mapping>
<identity value="idmp"/>
<map value="n/a"/>
</mapping>
<mapping>
<identity value="rim"/>
<map
value="ManufacturedProduct[classCode='MANU'].subjectOf.assignedEntity.assignedOrganization.contactParty"/>
</mapping>
</element>
<element id="MedicinalProductDefinition.clinicalTrial">
<path value="MedicinalProductDefinition.clinicalTrial"/>
<short
value="Clinical trials or studies that this product is involved in"/>
<definition
value="Clinical trials or studies that this product is involved in."/>
<min value="0"/>
<max value="*"/>
<base>
<path value="MedicinalProductDefinition.clinicalTrial"/>
<min value="0"/>
<max value="*"/>
</base>
<type>
<code value="Reference"/>
<targetProfile
value="http://hl7.org/fhir/StructureDefinition/ResearchStudy"/>
</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() > id.count())"/>
<source value="http://hl7.org/fhir/StructureDefinition/Element"/>
</constraint>
<mustSupport value="false"/>
<isModifier value="false"/>
<isSummary value="true"/>
<mapping>
<identity value="idmp"/>
<map value="Investigational Medicinal Product.Clinical Trial Status"/>
</mapping>
<mapping>
<identity value="rim"/>
<map
value="ManufacturedProduct[classCode='MANU'].subjectOf.monitoringProgram"/>
</mapping>
</element>
<element id="MedicinalProductDefinition.code">
<path value="MedicinalProductDefinition.code"/>
<short
value="A code that this product is known by, within some formal terminology"/>
<definition
value="A code that this product is known by, usually within some formal terminology, perhaps assigned by a third party (i.e. not the manufacturer or regulator). Products (types of medications) tend to be known by identifiers during development and within regulatory process. However when they are prescribed they tend to be identified by codes. The same product may be have multiple codes, applied to it by multiple organizations."/>
<min value="0"/>
<max value="*"/>
<base>
<path value="MedicinalProductDefinition.code"/>
<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() > 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="MedicationFormalRepresentation"/>
</extension>
<strength value="example"/>
<description
value="A coded concept that defines the type of a medication."/>
<valueSet value="http://hl7.org/fhir/ValueSet/medication-codes"/>
</binding>
<mapping>
<identity value="idmp"/>
<map value="n/a"/>
</mapping>
<mapping>
<identity value="rim"/>
<map
value="ManufacturedProduct[classCode='MANU'].manufacturedProduct[classCode='MMAT'].code"/>
</mapping>
</element>
<element id="MedicinalProductDefinition.name">
<path value="MedicinalProductDefinition.name"/>
<short
value="The product's name, including full name and possibly coded parts"/>
<definition value="EMA IG 1.14"/>
<min value="1"/>
<max value="*"/>
<base>
<path value="MedicinalProductDefinition.name"/>
<min value="1"/>
<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() > id.count())"/>
<source value="http://hl7.org/fhir/StructureDefinition/Element"/>
</constraint>
<mustSupport value="false"/>
<isModifier value="false"/>
<isSummary value="true"/>
<mapping>
<identity value="idmp"/>
<map value="Medicinal Product Name"/>
</mapping>
<mapping>
<identity value="rim"/>
<map
value="ManufacturedProduct[classCode='MANU'].manufacturedProduct.name"/>
</mapping>
</element>
<element id="MedicinalProductDefinition.name.id">
<path value="MedicinalProductDefinition.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="MedicinalProductDefinition.name.extension">
<path value="MedicinalProductDefinition.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() > 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="MedicinalProductDefinition.name.modifierExtension">
<path value="MedicinalProductDefinition.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() > 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="MedicinalProductDefinition.name.productName">
<path value="MedicinalProductDefinition.name.productName"/>
<short value="The full product name"/>
<definition value="EMA IG 1.14.1"/>
<min value="1"/>
<max value="1"/>
<base>
<path value="MedicinalProductDefinition.name.productName"/>
<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() > id.count())"/>
<source value="http://hl7.org/fhir/StructureDefinition/Element"/>
</constraint>
<mustSupport value="false"/>
<isModifier value="false"/>
<isSummary value="true"/>
<mapping>
<identity value="idmp"/>
<map value="Medicinal Product Name.Full Name"/>
</mapping>
<mapping>
<identity value="rim"/>
<map
value="ManufacturedProduct[classCode='MANU'].manufacturedProduct.name"/>
</mapping>
</element>
<element id="MedicinalProductDefinition.name.type">
<path value="MedicinalProductDefinition.name.type"/>
<short
value="Type of product name, such as rINN, BAN, Proprietary, Non-Proprietary"/>
<definition
value="Type of product name, such as rINN, BAN, Proprietary, Non-Proprietary."/>
<min value="0"/>
<max value="1"/>
<base>
<path value="MedicinalProductDefinition.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() > 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="ProductNameType"/>
</extension>
<strength value="example"/>
<description value="Type of a name for a Medicinal Product."/>
<valueSet
value="http://hl7.org/fhir/ValueSet/medicinal-product-name-type"/>
</binding>
<mapping>
<identity value="idmp"/>
<map value="n/a"/>
</mapping>
<mapping>
<identity value="rim"/>
<map
value="ManufacturedProduct[classCode='MANU'].manufacturedProduct.asNamedEntity.code"/>
</mapping>
</element>
<element id="MedicinalProductDefinition.name.part">
<path value="MedicinalProductDefinition.name.part"/>
<short value="Coding words or phrases of the name"/>
<definition value="Coding words or phrases of the name."/>
<min value="0"/>
<max value="*"/>
<base>
<path value="MedicinalProductDefinition.name.part"/>
<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() > id.count())"/>
<source value="http://hl7.org/fhir/StructureDefinition/Element"/>
</constraint>
<mustSupport value="false"/>
<isModifier value="false"/>
<isSummary value="true"/>
<mapping>
<identity value="idmp"/>
<map
value="(any and all of the name parts e.g. Medicinal Product Name.Formulation Part)"/>
</mapping>
<mapping>
<identity value="rim"/>
<map
value="ManufacturedProduct[classCode='MANU'].manufacturedProduct.name.suffix"/>
</mapping>
</element>
<element id="MedicinalProductDefinition.name.part.id">
<path value="MedicinalProductDefinition.name.part.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="MedicinalProductDefinition.name.part.extension">
<path value="MedicinalProductDefinition.name.part.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() > 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="MedicinalProductDefinition.name.part.modifierExtension">
<path value="MedicinalProductDefinition.name.part.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() > 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="MedicinalProductDefinition.name.part.part">
<path value="MedicinalProductDefinition.name.part.part"/>
<short value="A fragment of a product name"/>
<definition value="A fragment of a product name."/>
<min value="1"/>
<max value="1"/>
<base>
<path value="MedicinalProductDefinition.name.part.part"/>
<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() > id.count())"/>
<source value="http://hl7.org/fhir/StructureDefinition/Element"/>
</constraint>
<mustSupport value="false"/>
<isModifier value="false"/>
<isSummary value="true"/>
<mapping>
<identity value="idmp"/>
<map
value="(text of any of the name parts e.g. Medicinal Product Name.Formulation Part)"/>
</mapping>
<mapping>
<identity value="rim"/>
<map
value="ManufacturedProduct[classCode='MANU'].manufacturedProduct.name.suffix"/>
</mapping>
</element>
<element id="MedicinalProductDefinition.name.part.type">
<path value="MedicinalProductDefinition.name.part.type"/>
<short
value="Identifying type for this part of the name (e.g. strength part)"/>
<definition
value="Identifying type for this part of the name (e.g. strength part)."/>
<min value="1"/>
<max value="1"/>
<base>
<path value="MedicinalProductDefinition.name.part.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() > 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="ProductNamePartType"/>
</extension>
<strength value="example"/>
<description value="Type of part of a name for a Medicinal Product."/>
<valueSet
value="http://hl7.org/fhir/ValueSet/medicinal-product-name-part-type"/>
</binding>
<mapping>
<identity value="idmp"/>
<map value="(which of the name parts this is e.g. Formulation Part)"/>
</mapping>
<mapping>
<identity value="rim"/>
<map
value="ManufacturedProduct[classCode='MANU'].manufacturedProduct.asNamedEntity.code"/>
</mapping>
</element>
<element id="MedicinalProductDefinition.name.usage">
<path value="MedicinalProductDefinition.name.usage"/>
<short value="Country and jurisdiction where the name applies"/>
<definition value="EMA IG 1.14.2"/>
<min value="0"/>
<max value="*"/>
<base>
<path value="MedicinalProductDefinition.name.usage"/>
<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() > id.count())"/>
<source value="http://hl7.org/fhir/StructureDefinition/Element"/>
</constraint>
<mustSupport value="false"/>
<isModifier value="false"/>
<isSummary value="true"/>
<mapping>
<identity value="idmp"/>
<map value="Country / Language"/>
</mapping>
<mapping>
<identity value="rim"/>
<map
value="ManufacturedProduct[classCode='MANU'].manufacturedProduct.asNamedEntity"/>
</mapping>
</element>
<element id="MedicinalProductDefinition.name.usage.id">
<path value="MedicinalProductDefinition.name.usage.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="MedicinalProductDefinition.name.usage.extension">
<path value="MedicinalProductDefinition.name.usage.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() > 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="MedicinalProductDefinition.name.usage.modifierExtension">
<path value="MedicinalProductDefinition.name.usage.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() > 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="MedicinalProductDefinition.name.usage.country">
<path value="MedicinalProductDefinition.name.usage.country"/>
<short value="Country code for where this name applies"/>
<definition value="Country code for where this name applies."/>
<min value="1"/>
<max value="1"/>
<base>
<path value="MedicinalProductDefinition.name.usage.country"/>
<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() > 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="Country"/>
</extension>
<strength value="example"/>
<description value="Jurisdiction codes"/>
<valueSet value="http://hl7.org/fhir/ValueSet/country"/>
</binding>
<mapping>
<identity value="idmp"/>
<map value="Country / Language.Country"/>
</mapping>
<mapping>
<identity value="rim"/>
<map
value="ManufacturedProduct[classCode='MANU'].manufacturedProduct.asNamedEntity.assigningTerritory.code"/>
</mapping>
</element>
<element id="MedicinalProductDefinition.name.usage.country.id">
<path value="MedicinalProductDefinition.name.usage.country.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="MedicinalProductDefinition.name.usage.country.extension">
<path value="MedicinalProductDefinition.name.usage.country.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() > 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="MedicinalProductDefinition.name.usage.country.coding">
<path value="MedicinalProductDefinition.name.usage.country.coding"/>
<slicing>
<discriminator>
<type value="pattern"/>
<path value="system"/>
</discriminator>
<rules value="open"/>
</slicing>
<short value="EMA or ISO codes for country"/>
<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="0"/>
<max value="*"/>
<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() > 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.1-8, 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="MedicinalProductDefinition.name.usage.country.coding:ema">
<path value="MedicinalProductDefinition.name.usage.country.coding"/>
<sliceName value="ema"/>
<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="0"/>
<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() > 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.1-8, 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="MedicinalProductDefinition.name.usage.country.coding:ema.id">
<path value="MedicinalProductDefinition.name.usage.country.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="MedicinalProductDefinition.name.usage.country.coding:ema.extension">
<path
value="MedicinalProductDefinition.name.usage.country.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() > 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="MedicinalProductDefinition.name.usage.country.coding:ema.system">
<path
value="MedicinalProductDefinition.name.usage.country.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="https://spor.ema.europa.eu/v1/lists/100000000002"/>
<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() > 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.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="MedicinalProductDefinition.name.usage.country.coding:ema.version">
<path
value="MedicinalProductDefinition.name.usage.country.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() > 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="MedicinalProductDefinition.name.usage.country.coding:ema.code">
<path
value="MedicinalProductDefinition.name.usage.country.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() > 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="MedicinalProductDefinition.name.usage.country.coding:ema.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="MedicinalProductDefinition.name.usage.country.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() > 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="MedicinalProductDefinition.name.usage.country.coding:ema.userSelected">
<path
value="MedicinalProductDefinition.name.usage.country.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() > 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 "true"; fhir:target dt:CDCoding.codingRationale\#O ]"/>
</mapping>
</element>
<element id="MedicinalProductDefinition.name.usage.country.coding:iso">
<path value="MedicinalProductDefinition.name.usage.country.coding"/>
<sliceName value="iso"/>
<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="0"/>
<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() > 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.1-8, 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="MedicinalProductDefinition.name.usage.country.coding:iso.id">
<path value="MedicinalProductDefinition.name.usage.country.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="MedicinalProductDefinition.name.usage.country.coding:iso.extension">
<path
value="MedicinalProductDefinition.name.usage.country.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() > 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="MedicinalProductDefinition.name.usage.country.coding:iso.system">
<path
value="MedicinalProductDefinition.name.usage.country.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="https://www.hl7.org/fhir/valueset-country.html"/>
<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() > 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.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="MedicinalProductDefinition.name.usage.country.coding:iso.version">
<path
value="MedicinalProductDefinition.name.usage.country.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() > 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="MedicinalProductDefinition.name.usage.country.coding:iso.code">
<path
value="MedicinalProductDefinition.name.usage.country.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() > 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="MedicinalProductDefinition.name.usage.country.coding:iso.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="MedicinalProductDefinition.name.usage.country.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() > 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="MedicinalProductDefinition.name.usage.country.coding:iso.userSelected">
<path
value="MedicinalProductDefinition.name.usage.country.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() > 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 "true"; fhir:target dt:CDCoding.codingRationale\#O ]"/>
</mapping>
</element>
<element id="MedicinalProductDefinition.name.usage.country.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="MedicinalProductDefinition.name.usage.country.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() > 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="text/plain"]/data"/>
</mapping>
<mapping>
<identity value="orim"/>
<map
value="fhir:CodeableConcept.text rdfs:subPropertyOf dt:CD.originalText"/>
</mapping>
</element>
<element id="MedicinalProductDefinition.name.usage.jurisdiction">
<path value="MedicinalProductDefinition.name.usage.jurisdiction"/>
<short value="Jurisdiction code for where this name applies"/>
<definition
value="Jurisdiction code for where this name applies. A jurisdiction may be a sub- or supra-national entity (e.g. a state or a geographic region)."/>
<min value="0"/>
<max value="1"/>
<base>
<path value="MedicinalProductDefinition.name.usage.jurisdiction"/>
<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() > 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"/>
<map value="Country / Language.Jurisdiction"/>
</mapping>
<mapping>
<identity value="rim"/>
<map
value="ManufacturedProduct[classCode='MANU'].manufacturedProduct.asNamedEntity.assigningTerritory.code"/>
</mapping>
</element>
<element id="MedicinalProductDefinition.name.usage.language">
<path value="MedicinalProductDefinition.name.usage.language"/>
<short value="Language code for this name"/>
<definition value="Language code for this name."/>
<min value="1"/>
<max value="1"/>
<base>
<path value="MedicinalProductDefinition.name.usage.language"/>
<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() > 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"/>
<map value="Country / Language.Language"/>
</mapping>
<mapping>
<identity value="rim"/>
<map
value="ManufacturedProduct[classCode='MANU'].manufacturedProduct.asNamedEntity.name.@xml:lang"/>
</mapping>
</element>
<element id="MedicinalProductDefinition.name.usage.language.id">
<path value="MedicinalProductDefinition.name.usage.language.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="MedicinalProductDefinition.name.usage.language.extension">
<path value="MedicinalProductDefinition.name.usage.language.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() > 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="MedicinalProductDefinition.name.usage.language.coding">
<path value="MedicinalProductDefinition.name.usage.language.coding"/>
<slicing>
<discriminator>
<type value="pattern"/>
<path value="system"/>
</discriminator>
<rules value="open"/>
</slicing>
<short value="EMA or ISO codes for country"/>
<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="0"/>
<max value="*"/>
<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() > 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.1-8, 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="MedicinalProductDefinition.name.usage.language.coding:ema">
<path value="MedicinalProductDefinition.name.usage.language.coding"/>
<sliceName value="ema"/>
<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="0"/>
<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() > 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.1-8, 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="MedicinalProductDefinition.name.usage.language.coding:ema.id">
<path value="MedicinalProductDefinition.name.usage.language.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="MedicinalProductDefinition.name.usage.language.coding:ema.extension">
<path
value="MedicinalProductDefinition.name.usage.language.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() > 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="MedicinalProductDefinition.name.usage.language.coding:ema.system">
<path
value="MedicinalProductDefinition.name.usage.language.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="https://spor.ema.europa.eu/v1/lists/100000072057"/>
<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() > 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.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="MedicinalProductDefinition.name.usage.language.coding:ema.version">
<path
value="MedicinalProductDefinition.name.usage.language.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() > 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="MedicinalProductDefinition.name.usage.language.coding:ema.code">
<path
value="MedicinalProductDefinition.name.usage.language.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() > 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="MedicinalProductDefinition.name.usage.language.coding:ema.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="MedicinalProductDefinition.name.usage.language.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() > 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="MedicinalProductDefinition.name.usage.language.coding:ema.userSelected">
<path
value="MedicinalProductDefinition.name.usage.language.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() > 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 "true"; fhir:target dt:CDCoding.codingRationale\#O ]"/>
</mapping>
</element>
<element id="MedicinalProductDefinition.name.usage.language.coding:bcp">
<path value="MedicinalProductDefinition.name.usage.language.coding"/>
<sliceName value="bcp"/>
<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="0"/>
<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() > 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.1-8, 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="MedicinalProductDefinition.name.usage.language.coding:bcp.id">
<path value="MedicinalProductDefinition.name.usage.language.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="MedicinalProductDefinition.name.usage.language.coding:bcp.extension">
<path
value="MedicinalProductDefinition.name.usage.language.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() > 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="MedicinalProductDefinition.name.usage.language.coding:bcp.system">
<path
value="MedicinalProductDefinition.name.usage.language.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://hl7.org/fhir/ValueSet/all-languages"/>
<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() > 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.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="MedicinalProductDefinition.name.usage.language.coding:bcp.version">
<path
value="MedicinalProductDefinition.name.usage.language.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() > 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="MedicinalProductDefinition.name.usage.language.coding:bcp.code">
<path
value="MedicinalProductDefinition.name.usage.language.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() > 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="MedicinalProductDefinition.name.usage.language.coding:bcp.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="MedicinalProductDefinition.name.usage.language.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() > 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="MedicinalProductDefinition.name.usage.language.coding:bcp.userSelected">
<path
value="MedicinalProductDefinition.name.usage.language.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() > 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 "true"; fhir:target dt:CDCoding.codingRationale\#O ]"/>
</mapping>
</element>
<element id="MedicinalProductDefinition.name.usage.language.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="MedicinalProductDefinition.name.usage.language.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() > 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="text/plain"]/data"/>
</mapping>
<mapping>
<identity value="orim"/>
<map
value="fhir:CodeableConcept.text rdfs:subPropertyOf dt:CD.originalText"/>
</mapping>
</element>
<element id="MedicinalProductDefinition.crossReference">
<path value="MedicinalProductDefinition.crossReference"/>
<short
value="Reference to another product, e.g. for linking authorised to investigational product"/>
<definition
value="Reference to another product, e.g. for linking authorised to investigational product, or a virtual product."/>
<min value="0"/>
<max value="*"/>
<base>
<path value="MedicinalProductDefinition.crossReference"/>
<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() > id.count())"/>
<source value="http://hl7.org/fhir/StructureDefinition/Element"/>
</constraint>
<mustSupport value="false"/>
<isModifier value="false"/>
<isSummary value="true"/>
<mapping>
<identity value="idmp"/>
<map value="Product Cross-Reference"/>
</mapping>
<mapping>
<identity value="rim"/>
<map
value="ManufacturedProduct[classCode='MANU'].manufacturedProduct.asEquivalentEntity"/>
</mapping>
</element>
<element id="MedicinalProductDefinition.crossReference.id">
<path value="MedicinalProductDefinition.crossReference.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="MedicinalProductDefinition.crossReference.extension">
<path value="MedicinalProductDefinition.crossReference.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() > 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="MedicinalProductDefinition.crossReference.modifierExtension">
<path
value="MedicinalProductDefinition.crossReference.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() > 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="MedicinalProductDefinition.crossReference.product">
<path value="MedicinalProductDefinition.crossReference.product"/>
<short
value="Reference to another product, e.g. for linking authorised to investigational product"/>
<definition
value="Reference to another product, e.g. for linking authorised to investigational product."/>
<min value="1"/>
<max value="1"/>
<base>
<path value="MedicinalProductDefinition.crossReference.product"/>
<min value="1"/>
<max value="1"/>
</base>
<type>
<code value="CodeableReference"/>
<targetProfile
value="http://hl7.org/fhir/StructureDefinition/MedicinalProductDefinition"/>
</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() > id.count())"/>
<source value="http://hl7.org/fhir/StructureDefinition/Element"/>
</constraint>
<mustSupport value="false"/>
<isModifier value="false"/>
<isSummary value="true"/>
<mapping>
<identity value="idmp"/>
<map value="Product Cross-Reference"/>
</mapping>
<mapping>
<identity value="rim"/>
<map
value="ManufacturedProduct[classCode='MANU'].manufacturedProduct.asEquivalentEntity.definingMaterialKind.code"/>
</mapping>
</element>
<element id="MedicinalProductDefinition.crossReference.type">
<path value="MedicinalProductDefinition.crossReference.type"/>
<short
value="The type of relationship, for instance branded to generic or virtual to actual product"/>
<definition
value="The type of relationship, for instance branded to generic, virtual to actual product, product to development product (investigational), parallel import version."/>
<min value="0"/>
<max value="1"/>
<base>
<path value="MedicinalProductDefinition.crossReference.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() > 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="ProductCrossReferenceType"/>
</extension>
<strength value="example"/>
<description
value="Extra measures defined for a Medicinal Product, such as heightened reporting requirements."/>
<valueSet
value="http://hl7.org/fhir/ValueSet/medicinal-product-cross-reference-type"/>
</binding>
<mapping>
<identity value="idmp"/>
<map value="Product Cross-Reference"/>
</mapping>
<mapping>
<identity value="rim"/>
<map
value="ManufacturedProduct[classCode='MANU'].manufacturedProduct.asEquivalentEntity.code"/>
</mapping>
</element>
<element id="MedicinalProductDefinition.operation">
<path value="MedicinalProductDefinition.operation"/>
<short
value="A manufacturing or administrative process for the medicinal product"/>
<definition
value="A manufacturing or administrative process or step associated with (or performed on) the medicinal product."/>
<min value="0"/>
<max value="*"/>
<base>
<path value="MedicinalProductDefinition.operation"/>
<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() > id.count())"/>
<source value="http://hl7.org/fhir/StructureDefinition/Element"/>
</constraint>
<mustSupport value="false"/>
<isModifier value="false"/>
<isSummary value="true"/>
<mapping>
<identity value="idmp"/>
<map value="Manufacturing / Business Operation"/>
</mapping>
<mapping>
<identity value="rim"/>
<map value="ManufacturedProduct[classCode='MANU'].subjectOf.action"/>
</mapping>
</element>
<element id="MedicinalProductDefinition.operation.id">
<path value="MedicinalProductDefinition.operation.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="MedicinalProductDefinition.operation.extension">
<path value="MedicinalProductDefinition.operation.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() > 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="MedicinalProductDefinition.operation.modifierExtension">
<path value="MedicinalProductDefinition.operation.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() > 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="MedicinalProductDefinition.operation.type">
<path value="MedicinalProductDefinition.operation.type"/>
<short
value="The type of manufacturing operation e.g. manufacturing itself, re-packaging"/>
<definition
value="The type of manufacturing operation e.g. manufacturing itself, re-packaging. For the authorization of this, a RegulatedAuthorization would point to the same plan or activity referenced here."/>
<min value="0"/>
<max value="1"/>
<base>
<path value="MedicinalProductDefinition.operation.type"/>
<min value="0"/>
<max value="1"/>
</base>
<type>
<code value="CodeableReference"/>
<targetProfile
value="http://hl7.org/fhir/StructureDefinition/ActivityDefinition"/>
<targetProfile
value="http://hl7.org/fhir/StructureDefinition/PlanDefinition"/>
</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() > id.count())"/>
<source value="http://hl7.org/fhir/StructureDefinition/Element"/>
</constraint>
<mustSupport value="false"/>
<isModifier value="false"/>
<isSummary value="true"/>
<mapping>
<identity value="idmp"/>
<map value="Manufacturing / Business Operation.Operation Type"/>
</mapping>
<mapping>
<identity value="rim"/>
<map
value="ManufacturedProduct[classCode='MANU'].subjectOf.action.code"/>
</mapping>
</element>
<element id="MedicinalProductDefinition.operation.effectiveDate">
<path value="MedicinalProductDefinition.operation.effectiveDate"/>
<short value="Date range of applicability"/>
<definition value="Date range of applicability."/>
<min value="0"/>
<max value="1"/>
<base>
<path value="MedicinalProductDefinition.operation.effectiveDate"/>
<min value="0"/>
<max value="1"/>
</base>
<type>
<code value="Period"/>
</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() > id.count())"/>
<source value="http://hl7.org/fhir/StructureDefinition/Element"/>
</constraint>
<mustSupport value="false"/>
<isModifier value="false"/>
<isSummary value="true"/>
<mapping>
<identity value="idmp"/>
<map value="Manufacturing / Business Operation.Effective Date"/>
</mapping>
<mapping>
<identity value="rim"/>
<map
value="ManufacturedProduct[classCode='MANU'].subjectOf.action.effectiveTime"/>
</mapping>
</element>
<element id="MedicinalProductDefinition.operation.organization">
<path value="MedicinalProductDefinition.operation.organization"/>
<short
value="The organization responsible for the particular process, e.g. the manufacturer or importer"/>
<definition
value="The organization or establishment responsible for (or associated with) the particular process or step, examples include the manufacturer, importer, agent."/>
<min value="0"/>
<max value="*"/>
<base>
<path value="MedicinalProductDefinition.operation.organization"/>
<min value="0"/>
<max value="*"/>
</base>
<type>
<code value="Reference"/>
<targetProfile
value="http://hl7.org/fhir/StructureDefinition/Organization"/>
</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() > id.count())"/>
<source value="http://hl7.org/fhir/StructureDefinition/Element"/>
</constraint>
<mustSupport value="false"/>
<isModifier value="false"/>
<isSummary value="true"/>
<mapping>
<identity value="idmp"/>
<map value="Manufacturer / Establishment (Organisation)"/>
</mapping>
<mapping>
<identity value="rim"/>
<map
value="ManufacturedProduct[classCode='MANU'].subjectOf.action.participation.organzation"/>
</mapping>
</element>
<element
id="MedicinalProductDefinition.operation.confidentialityIndicator">
<path
value="MedicinalProductDefinition.operation.confidentialityIndicator"/>
<short
value="Specifies whether this process is considered proprietary or confidential"/>
<definition
value="Specifies whether this particular business or manufacturing process is considered proprietary or confidential."/>
<min value="0"/>
<max value="1"/>
<base>
<path
value="MedicinalProductDefinition.operation.confidentialityIndicator"/>
<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() > 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="ProductConfidentiality"/>
</extension>
<strength value="example"/>
<description
value="Confidentiality rating, e.g. commercial sensitivity for a Medicinal Product."/>
<valueSet
value="http://hl7.org/fhir/ValueSet/medicinal-product-confidentiality"/>
</binding>
<mapping>
<identity value="idmp"/>
<map
value="Manufacturing / Business Operation.Confidentiality Indicator"/>
</mapping>
<mapping>
<identity value="rim"/>
<map
value="ManufacturedProduct[classCode='MANU'].subjectOf.action.confidentialityCode"/>
</mapping>
</element>
<element id="MedicinalProductDefinition.characteristic">
<path value="MedicinalProductDefinition.characteristic"/>
<short
value="Key product features such as "sugar free", "modified release""/>
<definition
value="Allows the key product features to be recorded, such as "sugar free", "modified release", "parallel import"."/>
<min value="0"/>
<max value="*"/>
<base>
<path value="MedicinalProductDefinition.characteristic"/>
<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() > id.count())"/>
<source value="http://hl7.org/fhir/StructureDefinition/Element"/>
</constraint>
<mustSupport value="false"/>
<isModifier value="false"/>
<isSummary value="true"/>
<mapping>
<identity value="idmp"/>
<map value="Package Item (Container).Physical Characteristics"/>
</mapping>
<mapping>
<identity value="rim"/>
<map
value="ManufacturedProduct[classCode='MANU'].subjectOf.characteristic"/>
</mapping>
</element>
<element id="MedicinalProductDefinition.characteristic.id">
<path value="MedicinalProductDefinition.characteristic.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="MedicinalProductDefinition.characteristic.extension">
<path value="MedicinalProductDefinition.characteristic.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() > 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="MedicinalProductDefinition.characteristic.modifierExtension">
<path
value="MedicinalProductDefinition.characteristic.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() > 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="MedicinalProductDefinition.characteristic.type">
<path value="MedicinalProductDefinition.characteristic.type"/>
<short value="A code expressing the type of characteristic"/>
<definition value="A code expressing the type of characteristic."/>
<min value="1"/>
<max value="1"/>
<base>
<path value="MedicinalProductDefinition.characteristic.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() > 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="ProductCharacteristic"/>
</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"/>
<map value="Physical Characteristics, all attributes"/>
</mapping>
<mapping>
<identity value="rim"/>
<map
value="ManufacturedProduct[classCode='MANU'].subjectOf.characteristic[@code='{type}']"/>
</mapping>
</element>
<element id="MedicinalProductDefinition.characteristic.value[x]">
<path value="MedicinalProductDefinition.characteristic.value[x]"/>
<short value="A value for the characteristic"/>
<definition value="A value for the characteristic.text."/>
<comment
value="Text, as markdown, is intended to be used only when the item cannot ever reasonably be coded. Otherwise, for cases where a code is not available, but is feasible, use CodeableConcept.text."/>
<min value="0"/>
<max value="1"/>
<base>
<path value="MedicinalProductDefinition.characteristic.value[x]"/>
<min value="0"/>
<max value="1"/>
</base>
<type>
<code value="CodeableConcept"/>
</type>
<type>
<code value="markdown"/>
</type>
<type>
<code value="Quantity"/>
</type>
<type>
<code value="integer"/>
</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() > id.count())"/>
<source value="http://hl7.org/fhir/StructureDefinition/Element"/>
</constraint>
<mustSupport value="false"/>
<isModifier value="false"/>
<isSummary value="true"/>
<mapping>
<identity value="idmp"/>
<map value="Physical Characteristics, attribute's value"/>
</mapping>
<mapping>
<identity value="rim"/>
<map
value="ManufacturedProduct[classCode='MANU'].subjectOf.characteristic[@code='{type}'].value"/>
</mapping>
</element>
</snapshot>
<differential>
<element id="MedicinalProductDefinition.identifier">
<path value="MedicinalProductDefinition.identifier"/>
<slicing>
<discriminator>
<type value="pattern"/>
<path value="system"/>
</discriminator>
<rules value="open"/>
</slicing>
<short
value="Identifier for the medicinal product: MPID, EMA PMS ID, national ID, or other"/>
<definition
value="EMA IG 1.2 & 1.3. Identifier for the medicinal product: MPID, EMA PMS ID, national ID, or other. Not to be used for package or pharmaceutical product identifiers."/>
</element>
<element id="MedicinalProductDefinition.identifier:mpid">
<path value="MedicinalProductDefinition.identifier"/>
<sliceName value="mpid"/>
<short value="MPID"/>
<definition
value="EMA IG 1.2. MPID if exists. For UNICOM testing data fake MPIDs are used (Country code + MAH LocID + unique code). "/>
<min value="0"/>
<max value="1"/>
</element>
<element id="MedicinalProductDefinition.identifier:mpid.system">
<path value="MedicinalProductDefinition.identifier.system"/>
<min value="1"/>
<patternUri value="http://ema.europa.eu/fhir/mpId"/>
</element>
<element id="MedicinalProductDefinition.identifier:pmsid">
<path value="MedicinalProductDefinition.identifier"/>
<sliceName value="pmsid"/>
<short value="PMS ID"/>
<definition
value="EMA IG 1.1. EMA Product Management System identifier if exists. For UNICOM testing data fake PMS IDs can be used"/>
<min value="0"/>
<max value="1"/>
</element>
<element id="MedicinalProductDefinition.identifier:pmsid.system">
<path value="MedicinalProductDefinition.identifier.system"/>
<min value="1"/>
<patternUri value="http://ema.europa.eu/fhir/pmsId"/>
</element>
<element id="MedicinalProductDefinition.domain">
<path value="MedicinalProductDefinition.domain"/>
<definition value="EMA IG 1.3"/>
<binding>
<strength value="required"/>
<valueSet
value="http://unicom-project.eu/fhir/d4-12/ValueSet/domain-vs"/>
</binding>
</element>
<element id="MedicinalProductDefinition.status">
<path value="MedicinalProductDefinition.status"/>
<short
value="Status of the product's data. Default 200000005004 'Current'"/>
</element>
<element id="MedicinalProductDefinition.combinedPharmaceuticalDoseForm">
<path
value="MedicinalProductDefinition.combinedPharmaceuticalDoseForm"/>
<short
value="Authorised dose form for the product, incl combination package dose forms"/>
<definition
value="EMA IG 1.5 & 1.6. Authorised dose form for the whole product. As applicable in one of the SPOR RMS list Combined pharmaceutical dose form, Pharmaceutical dose form, Combined term, Combination Package"/>
<binding>
<strength value="required"/>
<valueSet
value="http://unicom-project.eu/fhir/d4-12/ValueSet/authorised-doseform-vs"/>
</binding>
</element>
<element id="MedicinalProductDefinition.legalStatusOfSupply">
<path value="MedicinalProductDefinition.legalStatusOfSupply"/>
<short value="Legal status of supply on the medicinal product level."/>
<definition
value="EMA IG 1.7. Legal status of supply on the medicinal product level. The same information can be repeated/differentiated on the package level"/>
<binding>
<strength value="required"/>
<valueSet
value="http://unicom-project.eu/fhir/d4-12/ValueSet/legal-status-for-the-supply-vs"/>
</binding>
</element>
<element id="MedicinalProductDefinition.classification">
<path value="MedicinalProductDefinition.classification"/>
<slicing>
<discriminator>
<type value="pattern"/>
<path value="coding.system"/>
</discriminator>
<rules value="open"/>
</slicing>
<short value="ATC or other classification"/>
<definition value="EMA IG 1.13"/>
</element>
<element id="MedicinalProductDefinition.classification:atc">
<path value="MedicinalProductDefinition.classification"/>
<sliceName value="atc"/>
<min value="0"/>
<max value="*"/>
</element>
<element id="MedicinalProductDefinition.classification:atc.coding">
<path value="MedicinalProductDefinition.classification.coding"/>
<slicing>
<discriminator>
<type value="pattern"/>
<path value="system"/>
</discriminator>
<rules value="open"/>
</slicing>
<short value="ATC classification"/>
<definition value="EMA IG 1.13.3"/>
</element>
<element id="MedicinalProductDefinition.classification:atc.coding:ema">
<path value="MedicinalProductDefinition.classification.coding"/>
<sliceName value="ema"/>
<short value="ATC classification as EMA SPOR code"/>
<min value="0"/>
<max value="1"/>
</element>
<element
id="MedicinalProductDefinition.classification:atc.coding:ema.system">
<path value="MedicinalProductDefinition.classification.coding.system"/>
<min value="1"/>
<patternUri value="https://spor.ema.europa.eu/v1/lists/100000093533"/>
</element>
<element id="MedicinalProductDefinition.classification:atc.coding:who">
<path value="MedicinalProductDefinition.classification.coding"/>
<sliceName value="who"/>
<short value="ATC classification as WHO ATC code"/>
<min value="0"/>
<max value="1"/>
</element>
<element
id="MedicinalProductDefinition.classification:atc.coding:who.system">
<path value="MedicinalProductDefinition.classification.coding.system"/>
<min value="1"/>
<patternUri value="http://www.whocc.no/atc"/>
</element>
<element id="MedicinalProductDefinition.name">
<path value="MedicinalProductDefinition.name"/>
<definition value="EMA IG 1.14"/>
</element>
<element id="MedicinalProductDefinition.name.productName">
<path value="MedicinalProductDefinition.name.productName"/>
<definition value="EMA IG 1.14.1"/>
</element>
<element id="MedicinalProductDefinition.name.usage">
<path value="MedicinalProductDefinition.name.usage"/>
<definition value="EMA IG 1.14.2"/>
</element>
<element id="MedicinalProductDefinition.name.usage.country.coding">
<path value="MedicinalProductDefinition.name.usage.country.coding"/>
<slicing>
<discriminator>
<type value="pattern"/>
<path value="system"/>
</discriminator>
<rules value="open"/>
</slicing>
<short value="EMA or ISO codes for country"/>
</element>
<element id="MedicinalProductDefinition.name.usage.country.coding:ema">
<path value="MedicinalProductDefinition.name.usage.country.coding"/>
<sliceName value="ema"/>
<min value="0"/>
<max value="1"/>
</element>
<element
id="MedicinalProductDefinition.name.usage.country.coding:ema.system">
<path
value="MedicinalProductDefinition.name.usage.country.coding.system"/>
<min value="1"/>
<patternUri value="https://spor.ema.europa.eu/v1/lists/100000000002"/>
</element>
<element id="MedicinalProductDefinition.name.usage.country.coding:iso">
<path value="MedicinalProductDefinition.name.usage.country.coding"/>
<sliceName value="iso"/>
<min value="0"/>
<max value="1"/>
</element>
<element
id="MedicinalProductDefinition.name.usage.country.coding:iso.system">
<path
value="MedicinalProductDefinition.name.usage.country.coding.system"/>
<min value="1"/>
<patternUri value="https://www.hl7.org/fhir/valueset-country.html"/>
</element>
<element id="MedicinalProductDefinition.name.usage.language.coding">
<path value="MedicinalProductDefinition.name.usage.language.coding"/>
<slicing>
<discriminator>
<type value="pattern"/>
<path value="system"/>
</discriminator>
<rules value="open"/>
</slicing>
<short value="EMA or ISO codes for country"/>
</element>
<element id="MedicinalProductDefinition.name.usage.language.coding:ema">
<path value="MedicinalProductDefinition.name.usage.language.coding"/>
<sliceName value="ema"/>
<min value="0"/>
<max value="1"/>
</element>
<element
id="MedicinalProductDefinition.name.usage.language.coding:ema.system">
<path
value="MedicinalProductDefinition.name.usage.language.coding.system"/>
<min value="1"/>
<patternUri value="https://spor.ema.europa.eu/v1/lists/100000072057"/>
</element>
<element id="MedicinalProductDefinition.name.usage.language.coding:bcp">
<path value="MedicinalProductDefinition.name.usage.language.coding"/>
<sliceName value="bcp"/>
<min value="0"/>
<max value="1"/>
</element>
<element
id="MedicinalProductDefinition.name.usage.language.coding:bcp.system">
<path
value="MedicinalProductDefinition.name.usage.language.coding.system"/>
<min value="1"/>
<patternUri value="http://hl7.org/fhir/ValueSet/all-languages"/>
</element>
</differential>
</StructureDefinition>