SPL Mapping FHIR Implementation Guide
0.1.0 - Build CI
SPL Mapping FHIR Implementation Guide
0.1.0 - Build CI
SPL Mapping FHIR Implementation Guide, published by HL7 International / Biomedical Research and Regulation. This guide is not an authorized publication; it is the continuous build for version 0.1.0 built by the FHIR (HL7® FHIR® Standard) CI Build. This version is based on the current content of https://github.com/HL7/fhir-spl/ and changes regularly. See the Directory of published versions
| Page standards status: Trial-use | Maturity Level: 1 |
XML representation of the ProductSubmissionDocumentLogicalModel logical model.
<StructureDefinition xmlns="http://hl7.org/fhir">
<id value="ProductSubmissionDocumentLogicalModel"/>
<text>
<status value="extensions"/>
<div xmlns="http://www.w3.org/1999/xhtml"><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 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_element.gif" alt="." style="background-color: white; background-color: inherit" title="Element" class="hierarchy"/> <a href="StructureDefinition-ProductSubmissionDocumentLogicalModel-definitions.html#ProductSubmissionDocument" title="A document that contains information about a product being submitted for approval to the FDA.">ProductSubmissionDocument</a><a name="ProductSubmissionDocument"> </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">*</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 href="http://hl7.org/fhir/R4B/element.html#Element">Element</a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><br/>Elements defined in Ancestors:<a href="http://hl7.org/fhir/R4B/element.html#Element" title="Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.">@id</a>, <a href="http://hl7.org/fhir/R4B/element.html#Element" title="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 manageable, 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.">extension</a><br/>Product Submission Document Logical Model<br/><span style="font-weight:bold">Instances of this logical model are not marked to be the target of a Reference</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_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_primitive.png" alt="." style="background-color: #F7F7F7; background-color: inherit" title="Primitive Data Type" class="hierarchy"/> <a href="StructureDefinition-ProductSubmissionDocumentLogicalModel-definitions.html#ProductSubmissionDocument.identifier" title="A unique identifier of this specific Product Submission document.">identifier</a><a name="ProductSubmissionDocument.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">1..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 href="http://hl7.org/fhir/R4B/datatypes.html#string">string</a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">Document Identifier</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_primitive.png" alt="." style="background-color: white; background-color: inherit" title="Primitive Data Type" class="hierarchy"/> <a href="StructureDefinition-ProductSubmissionDocumentLogicalModel-definitions.html#ProductSubmissionDocument.splVersion" title="A date reference to the SPL version being used for this document.">splVersion</a><a name="ProductSubmissionDocument.splVersion"> </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..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 href="http://hl7.org/fhir/R4B/datatypes.html#date">date</a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">Document SPL Version</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_primitive.png" alt="." style="background-color: #F7F7F7; background-color: inherit" title="Primitive Data Type" class="hierarchy"/> <a href="StructureDefinition-ProductSubmissionDocumentLogicalModel-definitions.html#ProductSubmissionDocument.submissionIdentifier" title="A unique identifier of the submission that remains constant across all versions/revisions of this document.">submissionIdentifier</a><a name="ProductSubmissionDocument.submissionIdentifier"> </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..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 href="http://hl7.org/fhir/R4B/datatypes.html#string">string</a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">Submission Identifier</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_primitive.png" alt="." style="background-color: white; background-color: inherit" title="Primitive Data Type" class="hierarchy"/> <a href="StructureDefinition-ProductSubmissionDocumentLogicalModel-definitions.html#ProductSubmissionDocument.versionNumber" title="An integer that provides a sequence to the versions of the submission document.">versionNumber</a><a name="ProductSubmissionDocument.versionNumber"> </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..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 href="http://hl7.org/fhir/R4B/datatypes.html#positiveInt">positiveInt</a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">Document Version Number</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_datatype.gif" alt="." style="background-color: #F7F7F7; background-color: inherit" title="Data Type" class="hierarchy"/> <a href="StructureDefinition-ProductSubmissionDocumentLogicalModel-definitions.html#ProductSubmissionDocument.type" title="A LOINC code that provides inforamtion on the Product Submission type.">type</a><a name="ProductSubmissionDocument.type"> </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..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 href="http://hl7.org/fhir/R4B/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">Document Type</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_primitive.png" alt="." style="background-color: white; background-color: inherit" title="Primitive Data Type" class="hierarchy"/> <a href="StructureDefinition-ProductSubmissionDocumentLogicalModel-definitions.html#ProductSubmissionDocument.title" title="The title for the document.">title</a><a name="ProductSubmissionDocument.title"> </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 href="http://hl7.org/fhir/R4B/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">Document Title</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_bck11.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_datatype.gif" alt="." style="background-color: #F7F7F7; background-color: inherit" title="Data Type" class="hierarchy"/> <a href="StructureDefinition-ProductSubmissionDocumentLogicalModel-definitions.html#ProductSubmissionDocument.labeler" title="Information about the labeler organization that authored the document.">labeler</a><a name="ProductSubmissionDocument.labeler"> </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..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 href="http://hl7.org/fhir/R4B/backboneelement.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">Product Labeler</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_bck110.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.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_primitive.png" alt="." style="background-color: white; background-color: inherit" title="Primitive Data Type" class="hierarchy"/> <a href="StructureDefinition-ProductSubmissionDocumentLogicalModel-definitions.html#ProductSubmissionDocument.labeler.dunsNumber" title="The Duns & Broadstreet number for the labeler organization.">dunsNumber</a><a name="ProductSubmissionDocument.labeler.dunsNumber"> </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..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 href="http://hl7.org/fhir/R4B/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">Product Labeler DUNS Number</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_bck110.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.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_primitive.png" alt="." style="background-color: #F7F7F7; background-color: inherit" title="Primitive Data Type" class="hierarchy"/> <a href="StructureDefinition-ProductSubmissionDocumentLogicalModel-definitions.html#ProductSubmissionDocument.labeler.name" title="The name of the labeler organization.">name</a><a name="ProductSubmissionDocument.labeler.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">1..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 href="http://hl7.org/fhir/R4B/datatypes.html#string">string</a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">Product Labeler Name</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_bck101.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin_end.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_datatype.gif" alt="." style="background-color: white; background-color: inherit" title="Data Type" class="hierarchy"/> <a href="StructureDefinition-ProductSubmissionDocumentLogicalModel-definitions.html#ProductSubmissionDocument.labeler.registrant" title="Information about the registrant organization associated with the labeler.">registrant</a><a name="ProductSubmissionDocument.labeler.registrant"> </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 href="http://hl7.org/fhir/R4B/backboneelement.html#BackboneElement">BackboneElement</a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">Product Labeler Registrant</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_bck1010.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.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_primitive.png" alt="." style="background-color: #F7F7F7; background-color: inherit" title="Primitive Data Type" class="hierarchy"/> <a href="StructureDefinition-ProductSubmissionDocumentLogicalModel-definitions.html#ProductSubmissionDocument.labeler.registrant.dunsNumber" title="The Duns & Broadstreet number for the registrant organization.">dunsNumber</a><a name="ProductSubmissionDocument.labeler.registrant.dunsNumber"> </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..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 href="http://hl7.org/fhir/R4B/datatypes.html#string">string</a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">Registrant DUNS Number</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_bck1010.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.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_primitive.png" alt="." style="background-color: white; background-color: inherit" title="Primitive Data Type" class="hierarchy"/> <a href="StructureDefinition-ProductSubmissionDocumentLogicalModel-definitions.html#ProductSubmissionDocument.labeler.registrant.name" title="The name of the registrant organization.">name</a><a name="ProductSubmissionDocument.labeler.registrant.name"> </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..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 href="http://hl7.org/fhir/R4B/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">Registrant Name</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_bck1001.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.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_datatype.gif" alt="." style="background-color: #F7F7F7; background-color: inherit" title="Data Type" class="hierarchy"/> <a href="StructureDefinition-ProductSubmissionDocumentLogicalModel-definitions.html#ProductSubmissionDocument.labeler.registrant.establishment" title="Information about the establishment organization associated with active or new marketed products.">establishment</a><a name="ProductSubmissionDocument.labeler.registrant.establishment"> </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..*</td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="http://hl7.org/fhir/R4B/backboneelement.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">Product Establishment<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_bck10010.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.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_primitive.png" alt="." style="background-color: white; background-color: inherit" title="Primitive Data Type" class="hierarchy"/> <a href="StructureDefinition-ProductSubmissionDocumentLogicalModel-definitions.html#ProductSubmissionDocument.labeler.registrant.establishment.dunsNumber" title="The Duns & Broadstreet number for the establishment organization.">dunsNumber</a><a name="ProductSubmissionDocument.labeler.registrant.establishment.dunsNumber"> </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..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 href="http://hl7.org/fhir/R4B/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">Establishment DUNS Number</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_bck10010.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.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_primitive.png" alt="." style="background-color: #F7F7F7; background-color: inherit" title="Primitive Data Type" class="hierarchy"/> <a href="StructureDefinition-ProductSubmissionDocumentLogicalModel-definitions.html#ProductSubmissionDocument.labeler.registrant.establishment.name" title="The name of the establishment organization.">name</a><a name="ProductSubmissionDocument.labeler.registrant.establishment.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">1..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 href="http://hl7.org/fhir/R4B/datatypes.html#string">string</a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">Establishment Name</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_bck10001.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_blank.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_blank.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin_end.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_datatype.gif" alt="." style="background-color: white; background-color: inherit" title="Data Type" class="hierarchy"/> <a href="StructureDefinition-ProductSubmissionDocumentLogicalModel-definitions.html#ProductSubmissionDocument.labeler.registrant.establishment.businessOperation" title="Various business operations that the Establishment organization performs.">businessOperation</a><a name="ProductSubmissionDocument.labeler.registrant.establishment.businessOperation"> </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..*</td><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/R4B/backboneelement.html#BackboneElement">BackboneElement</a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">Establishment Business Operations<br/></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_bck100010.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.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_datatype.gif" alt="." style="background-color: #F7F7F7; background-color: inherit" title="Data Type" class="hierarchy"/> <a href="StructureDefinition-ProductSubmissionDocumentLogicalModel-definitions.html#ProductSubmissionDocument.labeler.registrant.establishment.businessOperation.code" title="A code representing the specific business operation that the Establishment organization can perform.">code</a><a name="ProductSubmissionDocument.labeler.registrant.establishment.businessOperation.code"> </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..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 href="http://hl7.org/fhir/R4B/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">Business Operation Type</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_bck100000.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_blank.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_blank.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_blank.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin_end.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_datatype.gif" alt="." style="background-color: white; background-color: inherit" title="Data Type" class="hierarchy"/> <a href="StructureDefinition-ProductSubmissionDocumentLogicalModel-definitions.html#ProductSubmissionDocument.labeler.registrant.establishment.businessOperation.productNDC" title="The NDC code of the specific product that this business operation is about.">productNDC</a><a name="ProductSubmissionDocument.labeler.registrant.establishment.businessOperation.productNDC"> </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 href="http://hl7.org/fhir/R4B/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">Business Operation Product NDC</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_bck11.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_datatype.gif" alt="." style="background-color: #F7F7F7; background-color: inherit" title="Data Type" class="hierarchy"/> <a href="StructureDefinition-ProductSubmissionDocumentLogicalModel-definitions.html#ProductSubmissionDocument.relatedDocument" title="Reference to other documents that contain relevant information about this product submission.">relatedDocument</a><a name="ProductSubmissionDocument.relatedDocument"> </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 href="http://hl7.org/fhir/R4B/backboneelement.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">Reference to Related Document<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_bck110.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.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_primitive.png" alt="." style="background-color: white; background-color: inherit" title="Primitive Data Type" class="hierarchy"/> <a href="StructureDefinition-ProductSubmissionDocumentLogicalModel-definitions.html#ProductSubmissionDocument.relatedDocument.identifier" title="A unique identifier of this related document.">identifier</a><a name="ProductSubmissionDocument.relatedDocument.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"/><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">1..1</td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="http://hl7.org/fhir/R4B/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">Related Document Identifier</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_bck110.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.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_primitive.png" alt="." style="background-color: #F7F7F7; background-color: inherit" title="Primitive Data Type" class="hierarchy"/> <a href="StructureDefinition-ProductSubmissionDocumentLogicalModel-definitions.html#ProductSubmissionDocument.relatedDocument.submissionIdentifier" title="A unique identifier of the submission of this related document.">submissionIdentifier</a><a name="ProductSubmissionDocument.relatedDocument.submissionIdentifier"> </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..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 href="http://hl7.org/fhir/R4B/datatypes.html#string">string</a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">Related Document Submission Identifier</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_bck100.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin_end.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_primitive.png" alt="." style="background-color: white; background-color: inherit" title="Primitive Data Type" class="hierarchy"/> <a href="StructureDefinition-ProductSubmissionDocumentLogicalModel-definitions.html#ProductSubmissionDocument.relatedDocument.versionNumber" title="An integer that provides a sequence to the versions of the related document.">versionNumber</a><a name="ProductSubmissionDocument.relatedDocument.versionNumber"> </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..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 href="http://hl7.org/fhir/R4B/datatypes.html#positiveInt">positiveInt</a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">Related Document Version Number</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_datatype.gif" alt="." style="background-color: #F7F7F7; background-color: inherit" title="Data Type" class="hierarchy"/> <a href="StructureDefinition-ProductSubmissionDocumentLogicalModel-definitions.html#ProductSubmissionDocument.section" title="A logical grouping of Product Submission information.">section</a><a name="ProductSubmissionDocument.section"> </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..*</td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="http://hl7.org/fhir/R4B/backboneelement.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">Document Sections<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_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_primitive.png" alt="." style="background-color: white; background-color: inherit" title="Primitive Data Type" class="hierarchy"/> <a href="StructureDefinition-ProductSubmissionDocumentLogicalModel-definitions.html#ProductSubmissionDocument.section.identifier" title="An identifier for this section that can be used to reference it in the document.">identifier</a><a name="ProductSubmissionDocument.section.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"/><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">1..1</td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="http://hl7.org/fhir/R4B/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">Section Identifier</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_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_primitive.png" alt="." style="background-color: #F7F7F7; background-color: inherit" title="Primitive Data Type" class="hierarchy"/> <a href="StructureDefinition-ProductSubmissionDocumentLogicalModel-definitions.html#ProductSubmissionDocument.section.effectiveTime" title="The date when this section was authored.">effectiveTime</a><a name="ProductSubmissionDocument.section.effectiveTime"> </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..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 href="http://hl7.org/fhir/R4B/datatypes.html#date">date</a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">Section Effective Time</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_datatype.gif" alt="." style="background-color: white; background-color: inherit" title="Data Type" class="hierarchy"/> <a href="StructureDefinition-ProductSubmissionDocumentLogicalModel-definitions.html#ProductSubmissionDocument.section.type" title="A code that identifies the content conveyed in this section.">type</a><a name="ProductSubmissionDocument.section.type"> </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..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 href="http://hl7.org/fhir/R4B/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">Section Type</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_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_primitive.png" alt="." style="background-color: #F7F7F7; background-color: inherit" title="Primitive Data Type" class="hierarchy"/> <a href="StructureDefinition-ProductSubmissionDocumentLogicalModel-definitions.html#ProductSubmissionDocument.section.title" title="A header for the content contained in this section.">title</a><a name="ProductSubmissionDocument.section.title"> </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 href="http://hl7.org/fhir/R4B/datatypes.html#string">string</a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">Section Title</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_primitive.png" alt="." style="background-color: white; background-color: inherit" title="Primitive Data Type" class="hierarchy"/> <a href="StructureDefinition-ProductSubmissionDocumentLogicalModel-definitions.html#ProductSubmissionDocument.section.text" title="The human readable content of this section.">text</a><a name="ProductSubmissionDocument.section.text"> </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 href="http://hl7.org/fhir/R4B/narrative.html#xhtml">xhtml</a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">Section Text</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_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_primitive.png" alt="." style="background-color: #F7F7F7; background-color: inherit" title="Primitive Data Type" class="hierarchy"/> <a href="StructureDefinition-ProductSubmissionDocumentLogicalModel-definitions.html#ProductSubmissionDocument.section.highlights" title="Content that is not a complete rendering of the information in this section.">highlights</a><a name="ProductSubmissionDocument.section.highlights"> </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 href="http://hl7.org/fhir/R4B/narrative.html#xhtml">xhtml</a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">Section Text Highlights</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_bck011.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_blank.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_datatype.gif" alt="." style="background-color: white; background-color: inherit" title="Data Type" class="hierarchy"/> <a href="StructureDefinition-ProductSubmissionDocumentLogicalModel-definitions.html#ProductSubmissionDocument.section.image" title="References to images that are used in the human readable content of this section.">image</a><a name="ProductSubmissionDocument.section.image"> </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..*</td><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/R4B/backboneelement.html#BackboneElement">BackboneElement</a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">Section Images<br/></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_bck0110.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_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_primitive.png" alt="." style="background-color: #F7F7F7; background-color: inherit" title="Primitive Data Type" class="hierarchy"/> <a href="StructureDefinition-ProductSubmissionDocumentLogicalModel-definitions.html#ProductSubmissionDocument.section.image.name" title="Title of the image.">name</a><a name="ProductSubmissionDocument.section.image.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">1..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 href="http://hl7.org/fhir/R4B/datatypes.html#string">string</a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">Image Title</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_bck0100.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_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_primitive.png" alt="." style="background-color: white; background-color: inherit" title="Primitive Data Type" class="hierarchy"/> <a href="StructureDefinition-ProductSubmissionDocumentLogicalModel-definitions.html#ProductSubmissionDocument.section.image.reference" title="Reference, either local or remote, to the image data.">reference</a><a name="ProductSubmissionDocument.section.image.reference"> </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..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 href="http://hl7.org/fhir/R4B/datatypes.html#url">url</a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">Image Reference</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_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_resource.png" alt="." style="background-color: #F7F7F7; background-color: inherit" title="Resource" class="hierarchy"/> <a href="StructureDefinition-ProductSubmissionDocumentLogicalModel-definitions.html#ProductSubmissionDocument.section.product" title="The complete definition of a medication being submitted in this document.">product</a><a name="ProductSubmissionDocument.section.product"> </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 href="StructureDefinition-SubmittedMedicationLogicalModel.html">SubmittedMedication</a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">Section Product Information<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_bck000.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_blank.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin_end.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_datatype.gif" alt="." style="background-color: white; background-color: inherit" title="Data Type" class="hierarchy"/> <a href="StructureDefinition-ProductSubmissionDocumentLogicalModel-definitions.html#ProductSubmissionDocument.section.subsection" title="subsection">subsection</a><a name="ProductSubmissionDocument.section.subsection"> </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..*</td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">See <a href="#ProductSubmissionDocument.section" title="ProductSubmissionDocument.section">section</a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">subsection<br/></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>
<extension
url="http://hl7.org/fhir/StructureDefinition/structuredefinition-wg">
<valueCode value="brr"/>
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<extension
url="http://hl7.org/fhir/StructureDefinition/structuredefinition-fmm">
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<extension
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<valueCanonical
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<extension
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<valueCode value="trial-use">
<extension
url="http://hl7.org/fhir/StructureDefinition/structuredefinition-conformance-derivedFrom">
<valueCanonical
value="http://hl7.org/fhir/us/spl/ImplementationGuide/hl7.fhir.us.spl"/>
</extension>
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</extension>
<url
value="http://hl7.org/fhir/us/spl/StructureDefinition/ProductSubmissionDocumentLogicalModel"/>
<version value="0.1.0"/>
<name value="ProductSubmissionDocumentLogicalModel"/>
<title value="Product Submission Document Logical Model"/>
<status value="active"/>
<date value="2024-05-16T19:43:56+00:00"/>
<publisher value="HL7 International / Biomedical Research and Regulation"/>
<contact>
<name value="HL7 International / Biomedical Research and Regulation"/>
<telecom>
<system value="url"/>
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</telecom>
</contact>
<description
value="A document that contains information about a product being submitted for approval to the FDA."/>
<jurisdiction>
<coding>
<system value="urn:iso:std:iso:3166"/>
<code value="US"/>
<display value="United States of America"/>
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<fhirVersion value="4.3.0"/>
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<identity value="rim"/>
<uri value="http://hl7.org/v3"/>
<name value="RIM Mapping"/>
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<kind value="logical"/>
<abstract value="false"/>
<type value="ProductSubmissionDocument"/>
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<derivation value="specialization"/>
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<element id="ProductSubmissionDocument">
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<definition
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<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"/>
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<base>
<path value="Element.extension"/>
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<code value="Extension"/>
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<xpath value="@value|f:*|h:div"/>
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<identity value="rim"/>
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<element id="ProductSubmissionDocument.identifier">
<path value="ProductSubmissionDocument.identifier"/>
<short value="Document Identifier"/>
<definition
value="A unique identifier of this specific Product Submission document."/>
<min value="1"/>
<max value="1"/>
<base>
<path value="ProductSubmissionDocument.identifier"/>
<min value="1"/>
<max value="1"/>
</base>
<type>
<code value="string"/>
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</element>
<element id="ProductSubmissionDocument.splVersion">
<path value="ProductSubmissionDocument.splVersion"/>
<short value="Document SPL Version"/>
<definition
value="A date reference to the SPL version being used for this document."/>
<min value="1"/>
<max value="1"/>
<base>
<path value="ProductSubmissionDocument.splVersion"/>
<min value="1"/>
<max value="1"/>
</base>
<type>
<code value="date"/>
</type>
</element>
<element id="ProductSubmissionDocument.submissionIdentifier">
<path value="ProductSubmissionDocument.submissionIdentifier"/>
<short value="Submission Identifier"/>
<definition
value="A unique identifier of the submission that remains constant across all versions/revisions of this document."/>
<min value="1"/>
<max value="1"/>
<base>
<path value="ProductSubmissionDocument.submissionIdentifier"/>
<min value="1"/>
<max value="1"/>
</base>
<type>
<code value="string"/>
</type>
</element>
<element id="ProductSubmissionDocument.versionNumber">
<path value="ProductSubmissionDocument.versionNumber"/>
<short value="Document Version Number"/>
<definition
value="An integer that provides a sequence to the versions of the submission document."/>
<min value="1"/>
<max value="1"/>
<base>
<path value="ProductSubmissionDocument.versionNumber"/>
<min value="1"/>
<max value="1"/>
</base>
<type>
<code value="positiveInt"/>
</type>
</element>
<element id="ProductSubmissionDocument.type">
<path value="ProductSubmissionDocument.type"/>
<short value="Document Type"/>
<definition
value="A LOINC code that provides inforamtion on the Product Submission type."/>
<min value="1"/>
<max value="1"/>
<base>
<path value="ProductSubmissionDocument.type"/>
<min value="1"/>
<max value="1"/>
</base>
<type>
<code value="CodeableConcept"/>
</type>
</element>
<element id="ProductSubmissionDocument.title">
<path value="ProductSubmissionDocument.title"/>
<short value="Document Title"/>
<definition value="The title for the document."/>
<min value="0"/>
<max value="1"/>
<base>
<path value="ProductSubmissionDocument.title"/>
<min value="0"/>
<max value="1"/>
</base>
<type>
<code value="string"/>
</type>
</element>
<element id="ProductSubmissionDocument.labeler">
<path value="ProductSubmissionDocument.labeler"/>
<short value="Product Labeler"/>
<definition
value="Information about the labeler organization that authored the document."/>
<min value="1"/>
<max value="1"/>
<base>
<path value="ProductSubmissionDocument.labeler"/>
<min value="1"/>
<max value="1"/>
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<type>
<code value="BackboneElement"/>
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<constraint>
<key value="ele-1"/>
<severity value="error"/>
<human
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<expression
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<xpath value="@value|f:*|h:div|self::f:Parameters"/>
<source value="http://hl7.org/fhir/StructureDefinition/Element"/>
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<element id="ProductSubmissionDocument.labeler.id">
<path value="ProductSubmissionDocument.labeler.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"/>
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<type>
<extension
url="http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type">
<valueUrl value="id"/>
</extension>
<code value="http://hl7.org/fhirpath/System.String"/>
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<isModifier value="false"/>
<isSummary value="false"/>
<mapping>
<identity value="rim"/>
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<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"/>
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<severity value="error"/>
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<severity value="error"/>
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<expression value="extension.exists() != value.exists()"/>
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<element id="ProductSubmissionDocument.labeler.modifierExtension">
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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 manageable, 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/R4B/extensibility.html#modifierExtension)."/>
<alias value="extensions"/>
<alias value="user content"/>
<alias value="modifiers"/>
<min value="0"/>
<max value="*"/>
<base>
<path value="BackboneElement.modifierExtension"/>
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<max value="*"/>
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<code value="Extension"/>
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<severity value="error"/>
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<severity value="error"/>
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<expression value="extension.exists() != value.exists()"/>
<xpath
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<source value="http://hl7.org/fhir/StructureDefinition/Extension"/>
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<isModifier value="true"/>
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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"/>
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</element>
<element id="ProductSubmissionDocument.labeler.dunsNumber">
<path value="ProductSubmissionDocument.labeler.dunsNumber"/>
<short value="Product Labeler DUNS Number"/>
<definition
value="The Duns & Broadstreet number for the labeler organization."/>
<min value="1"/>
<max value="1"/>
<base>
<path value="ProductSubmissionDocument.labeler.dunsNumber"/>
<min value="1"/>
<max value="1"/>
</base>
<type>
<code value="string"/>
</type>
</element>
<element id="ProductSubmissionDocument.labeler.name">
<path value="ProductSubmissionDocument.labeler.name"/>
<short value="Product Labeler Name"/>
<definition value="The name of the labeler organization."/>
<min value="1"/>
<max value="1"/>
<base>
<path value="ProductSubmissionDocument.labeler.name"/>
<min value="1"/>
<max value="1"/>
</base>
<type>
<code value="string"/>
</type>
</element>
<element id="ProductSubmissionDocument.labeler.registrant">
<path value="ProductSubmissionDocument.labeler.registrant"/>
<short value="Product Labeler Registrant"/>
<definition
value="Information about the registrant organization associated with the labeler."/>
<min value="0"/>
<max value="1"/>
<base>
<path value="ProductSubmissionDocument.labeler.registrant"/>
<min value="0"/>
<max value="1"/>
</base>
<type>
<code value="BackboneElement"/>
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<constraint>
<key value="ele-1"/>
<severity value="error"/>
<human
value="All FHIR elements must have a @value or children unless an empty Parameters resource"/>
<expression
value="hasValue() or (children().count() > id.count()) or $this is Parameters"/>
<xpath value="@value|f:*|h:div|self::f:Parameters"/>
<source value="http://hl7.org/fhir/StructureDefinition/Element"/>
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<element id="ProductSubmissionDocument.labeler.registrant.id">
<path value="ProductSubmissionDocument.labeler.registrant.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>
<isModifier value="false"/>
<isSummary value="false"/>
<mapping>
<identity value="rim"/>
<map value="n/a"/>
</mapping>
</element>
<element id="ProductSubmissionDocument.labeler.registrant.extension">
<path value="ProductSubmissionDocument.labeler.registrant.extension"/>
<slicing>
<discriminator>
<type value="value"/>
<path value="url"/>
</discriminator>
<description value="Extensions are always sliced by (at least) url"/>
<rules value="open"/>
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<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 manageable, 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())"/>
<xpath value="@value|f:*|h:div"/>
<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()"/>
<xpath
value="exists(f:extension)!=exists(f:*[starts-with(local-name(.), "value")])"/>
<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="ProductSubmissionDocument.labeler.registrant.modifierExtension">
<path
value="ProductSubmissionDocument.labeler.registrant.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 manageable, 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/R4B/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())"/>
<xpath value="@value|f:*|h:div"/>
<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()"/>
<xpath
value="exists(f:extension)!=exists(f:*[starts-with(local-name(.), "value")])"/>
<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="ProductSubmissionDocument.labeler.registrant.dunsNumber">
<path value="ProductSubmissionDocument.labeler.registrant.dunsNumber"/>
<short value="Registrant DUNS Number"/>
<definition
value="The Duns & Broadstreet number for the registrant organization."/>
<min value="1"/>
<max value="1"/>
<base>
<path
value="ProductSubmissionDocument.labeler.registrant.dunsNumber"/>
<min value="1"/>
<max value="1"/>
</base>
<type>
<code value="string"/>
</type>
</element>
<element id="ProductSubmissionDocument.labeler.registrant.name">
<path value="ProductSubmissionDocument.labeler.registrant.name"/>
<short value="Registrant Name"/>
<definition value="The name of the registrant organization."/>
<min value="1"/>
<max value="1"/>
<base>
<path value="ProductSubmissionDocument.labeler.registrant.name"/>
<min value="1"/>
<max value="1"/>
</base>
<type>
<code value="string"/>
</type>
</element>
<element id="ProductSubmissionDocument.labeler.registrant.establishment">
<path
value="ProductSubmissionDocument.labeler.registrant.establishment"/>
<short value="Product Establishment"/>
<definition
value="Information about the establishment organization associated with active or new marketed products."/>
<min value="1"/>
<max value="*"/>
<base>
<path
value="ProductSubmissionDocument.labeler.registrant.establishment"/>
<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 unless an empty Parameters resource"/>
<expression
value="hasValue() or (children().count() > id.count()) or $this is Parameters"/>
<xpath value="@value|f:*|h:div|self::f:Parameters"/>
<source value="http://hl7.org/fhir/StructureDefinition/Element"/>
</constraint>
</element>
<element
id="ProductSubmissionDocument.labeler.registrant.establishment.id">
<path
value="ProductSubmissionDocument.labeler.registrant.establishment.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>
<isModifier value="false"/>
<isSummary value="false"/>
<mapping>
<identity value="rim"/>
<map value="n/a"/>
</mapping>
</element>
<element
id="ProductSubmissionDocument.labeler.registrant.establishment.extension">
<path
value="ProductSubmissionDocument.labeler.registrant.establishment.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 manageable, 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())"/>
<xpath value="@value|f:*|h:div"/>
<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()"/>
<xpath
value="exists(f:extension)!=exists(f:*[starts-with(local-name(.), "value")])"/>
<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="ProductSubmissionDocument.labeler.registrant.establishment.modifierExtension">
<path
value="ProductSubmissionDocument.labeler.registrant.establishment.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 manageable, 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/R4B/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())"/>
<xpath value="@value|f:*|h:div"/>
<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()"/>
<xpath
value="exists(f:extension)!=exists(f:*[starts-with(local-name(.), "value")])"/>
<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="ProductSubmissionDocument.labeler.registrant.establishment.dunsNumber">
<path
value="ProductSubmissionDocument.labeler.registrant.establishment.dunsNumber"/>
<short value="Establishment DUNS Number"/>
<definition
value="The Duns & Broadstreet number for the establishment organization."/>
<min value="1"/>
<max value="1"/>
<base>
<path
value="ProductSubmissionDocument.labeler.registrant.establishment.dunsNumber"/>
<min value="1"/>
<max value="1"/>
</base>
<type>
<code value="string"/>
</type>
</element>
<element
id="ProductSubmissionDocument.labeler.registrant.establishment.name">
<path
value="ProductSubmissionDocument.labeler.registrant.establishment.name"/>
<short value="Establishment Name"/>
<definition value="The name of the establishment organization."/>
<min value="1"/>
<max value="1"/>
<base>
<path
value="ProductSubmissionDocument.labeler.registrant.establishment.name"/>
<min value="1"/>
<max value="1"/>
</base>
<type>
<code value="string"/>
</type>
</element>
<element
id="ProductSubmissionDocument.labeler.registrant.establishment.businessOperation">
<path
value="ProductSubmissionDocument.labeler.registrant.establishment.businessOperation"/>
<short value="Establishment Business Operations"/>
<definition
value="Various business operations that the Establishment organization performs."/>
<min value="1"/>
<max value="*"/>
<base>
<path
value="ProductSubmissionDocument.labeler.registrant.establishment.businessOperation"/>
<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 unless an empty Parameters resource"/>
<expression
value="hasValue() or (children().count() > id.count()) or $this is Parameters"/>
<xpath value="@value|f:*|h:div|self::f:Parameters"/>
<source value="http://hl7.org/fhir/StructureDefinition/Element"/>
</constraint>
</element>
<element
id="ProductSubmissionDocument.labeler.registrant.establishment.businessOperation.id">
<path
value="ProductSubmissionDocument.labeler.registrant.establishment.businessOperation.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>
<isModifier value="false"/>
<isSummary value="false"/>
<mapping>
<identity value="rim"/>
<map value="n/a"/>
</mapping>
</element>
<element
id="ProductSubmissionDocument.labeler.registrant.establishment.businessOperation.extension">
<path
value="ProductSubmissionDocument.labeler.registrant.establishment.businessOperation.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 manageable, 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())"/>
<xpath value="@value|f:*|h:div"/>
<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()"/>
<xpath
value="exists(f:extension)!=exists(f:*[starts-with(local-name(.), "value")])"/>
<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="ProductSubmissionDocument.labeler.registrant.establishment.businessOperation.modifierExtension">
<path
value="ProductSubmissionDocument.labeler.registrant.establishment.businessOperation.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 manageable, 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/R4B/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())"/>
<xpath value="@value|f:*|h:div"/>
<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()"/>
<xpath
value="exists(f:extension)!=exists(f:*[starts-with(local-name(.), "value")])"/>
<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="ProductSubmissionDocument.labeler.registrant.establishment.businessOperation.code">
<path
value="ProductSubmissionDocument.labeler.registrant.establishment.businessOperation.code"/>
<short value="Business Operation Type"/>
<definition
value="A code representing the specific business operation that the Establishment organization can perform."/>
<min value="1"/>
<max value="1"/>
<base>
<path
value="ProductSubmissionDocument.labeler.registrant.establishment.businessOperation.code"/>
<min value="1"/>
<max value="1"/>
</base>
<type>
<code value="CodeableConcept"/>
</type>
</element>
<element
id="ProductSubmissionDocument.labeler.registrant.establishment.businessOperation.productNDC">
<path
value="ProductSubmissionDocument.labeler.registrant.establishment.businessOperation.productNDC"/>
<short value="Business Operation Product NDC"/>
<definition
value="The NDC code of the specific product that this business operation is about."/>
<min value="0"/>
<max value="1"/>
<base>
<path
value="ProductSubmissionDocument.labeler.registrant.establishment.businessOperation.productNDC"/>
<min value="0"/>
<max value="1"/>
</base>
<type>
<code value="CodeableConcept"/>
</type>
</element>
<element id="ProductSubmissionDocument.relatedDocument">
<path value="ProductSubmissionDocument.relatedDocument"/>
<short value="Reference to Related Document"/>
<definition
value="Reference to other documents that contain relevant information about this product submission."/>
<min value="0"/>
<max value="*"/>
<base>
<path value="ProductSubmissionDocument.relatedDocument"/>
<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 unless an empty Parameters resource"/>
<expression
value="hasValue() or (children().count() > id.count()) or $this is Parameters"/>
<xpath value="@value|f:*|h:div|self::f:Parameters"/>
<source value="http://hl7.org/fhir/StructureDefinition/Element"/>
</constraint>
</element>
<element id="ProductSubmissionDocument.relatedDocument.id">
<path value="ProductSubmissionDocument.relatedDocument.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>
<isModifier value="false"/>
<isSummary value="false"/>
<mapping>
<identity value="rim"/>
<map value="n/a"/>
</mapping>
</element>
<element id="ProductSubmissionDocument.relatedDocument.extension">
<path value="ProductSubmissionDocument.relatedDocument.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 manageable, 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())"/>
<xpath value="@value|f:*|h:div"/>
<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()"/>
<xpath
value="exists(f:extension)!=exists(f:*[starts-with(local-name(.), "value")])"/>
<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="ProductSubmissionDocument.relatedDocument.modifierExtension">
<path
value="ProductSubmissionDocument.relatedDocument.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 manageable, 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/R4B/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())"/>
<xpath value="@value|f:*|h:div"/>
<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()"/>
<xpath
value="exists(f:extension)!=exists(f:*[starts-with(local-name(.), "value")])"/>
<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="ProductSubmissionDocument.relatedDocument.identifier">
<path value="ProductSubmissionDocument.relatedDocument.identifier"/>
<short value="Related Document Identifier"/>
<definition value="A unique identifier of this related document."/>
<min value="1"/>
<max value="1"/>
<base>
<path value="ProductSubmissionDocument.relatedDocument.identifier"/>
<min value="1"/>
<max value="1"/>
</base>
<type>
<code value="string"/>
</type>
</element>
<element
id="ProductSubmissionDocument.relatedDocument.submissionIdentifier">
<path
value="ProductSubmissionDocument.relatedDocument.submissionIdentifier"/>
<short value="Related Document Submission Identifier"/>
<definition
value="A unique identifier of the submission of this related document."/>
<min value="1"/>
<max value="1"/>
<base>
<path
value="ProductSubmissionDocument.relatedDocument.submissionIdentifier"/>
<min value="1"/>
<max value="1"/>
</base>
<type>
<code value="string"/>
</type>
</element>
<element id="ProductSubmissionDocument.relatedDocument.versionNumber">
<path value="ProductSubmissionDocument.relatedDocument.versionNumber"/>
<short value="Related Document Version Number"/>
<definition
value="An integer that provides a sequence to the versions of the related document."/>
<min value="1"/>
<max value="1"/>
<base>
<path
value="ProductSubmissionDocument.relatedDocument.versionNumber"/>
<min value="1"/>
<max value="1"/>
</base>
<type>
<code value="positiveInt"/>
</type>
</element>
<element id="ProductSubmissionDocument.section">
<path value="ProductSubmissionDocument.section"/>
<short value="Document Sections"/>
<definition
value="A logical grouping of Product Submission information."/>
<min value="1"/>
<max value="*"/>
<base>
<path value="ProductSubmissionDocument.section"/>
<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 unless an empty Parameters resource"/>
<expression
value="hasValue() or (children().count() > id.count()) or $this is Parameters"/>
<xpath value="@value|f:*|h:div|self::f:Parameters"/>
<source value="http://hl7.org/fhir/StructureDefinition/Element"/>
</constraint>
</element>
<element id="ProductSubmissionDocument.section.id">
<path value="ProductSubmissionDocument.section.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>
<isModifier value="false"/>
<isSummary value="false"/>
<mapping>
<identity value="rim"/>
<map value="n/a"/>
</mapping>
</element>
<element id="ProductSubmissionDocument.section.extension">
<path value="ProductSubmissionDocument.section.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 manageable, 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())"/>
<xpath value="@value|f:*|h:div"/>
<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()"/>
<xpath
value="exists(f:extension)!=exists(f:*[starts-with(local-name(.), "value")])"/>
<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="ProductSubmissionDocument.section.modifierExtension">
<path value="ProductSubmissionDocument.section.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 manageable, 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/R4B/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())"/>
<xpath value="@value|f:*|h:div"/>
<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()"/>
<xpath
value="exists(f:extension)!=exists(f:*[starts-with(local-name(.), "value")])"/>
<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="ProductSubmissionDocument.section.identifier">
<path value="ProductSubmissionDocument.section.identifier"/>
<short value="Section Identifier"/>
<definition
value="An identifier for this section that can be used to reference it in the document."/>
<min value="1"/>
<max value="1"/>
<base>
<path value="ProductSubmissionDocument.section.identifier"/>
<min value="1"/>
<max value="1"/>
</base>
<type>
<code value="string"/>
</type>
</element>
<element id="ProductSubmissionDocument.section.effectiveTime">
<path value="ProductSubmissionDocument.section.effectiveTime"/>
<short value="Section Effective Time"/>
<definition value="The date when this section was authored."/>
<min value="1"/>
<max value="1"/>
<base>
<path value="ProductSubmissionDocument.section.effectiveTime"/>
<min value="1"/>
<max value="1"/>
</base>
<type>
<code value="date"/>
</type>
</element>
<element id="ProductSubmissionDocument.section.type">
<path value="ProductSubmissionDocument.section.type"/>
<short value="Section Type"/>
<definition
value="A code that identifies the content conveyed in this section."/>
<min value="1"/>
<max value="1"/>
<base>
<path value="ProductSubmissionDocument.section.type"/>
<min value="1"/>
<max value="1"/>
</base>
<type>
<code value="CodeableConcept"/>
</type>
</element>
<element id="ProductSubmissionDocument.section.title">
<path value="ProductSubmissionDocument.section.title"/>
<short value="Section Title"/>
<definition
value="A header for the content contained in this section."/>
<min value="0"/>
<max value="1"/>
<base>
<path value="ProductSubmissionDocument.section.title"/>
<min value="0"/>
<max value="1"/>
</base>
<type>
<code value="string"/>
</type>
</element>
<element id="ProductSubmissionDocument.section.text">
<path value="ProductSubmissionDocument.section.text"/>
<short value="Section Text"/>
<definition value="The human readable content of this section."/>
<min value="0"/>
<max value="1"/>
<base>
<path value="ProductSubmissionDocument.section.text"/>
<min value="0"/>
<max value="1"/>
</base>
<type>
<code value="xhtml"/>
</type>
</element>
<element id="ProductSubmissionDocument.section.highlights">
<path value="ProductSubmissionDocument.section.highlights"/>
<short value="Section Text Highlights"/>
<definition
value="Content that is not a complete rendering of the information in this section."/>
<min value="0"/>
<max value="1"/>
<base>
<path value="ProductSubmissionDocument.section.highlights"/>
<min value="0"/>
<max value="1"/>
</base>
<type>
<code value="xhtml"/>
</type>
</element>
<element id="ProductSubmissionDocument.section.image">
<path value="ProductSubmissionDocument.section.image"/>
<short value="Section Images"/>
<definition
value="References to images that are used in the human readable content of this section."/>
<min value="0"/>
<max value="*"/>
<base>
<path value="ProductSubmissionDocument.section.image"/>
<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 unless an empty Parameters resource"/>
<expression
value="hasValue() or (children().count() > id.count()) or $this is Parameters"/>
<xpath value="@value|f:*|h:div|self::f:Parameters"/>
<source value="http://hl7.org/fhir/StructureDefinition/Element"/>
</constraint>
</element>
<element id="ProductSubmissionDocument.section.image.id">
<path value="ProductSubmissionDocument.section.image.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>
<isModifier value="false"/>
<isSummary value="false"/>
<mapping>
<identity value="rim"/>
<map value="n/a"/>
</mapping>
</element>
<element id="ProductSubmissionDocument.section.image.extension">
<path value="ProductSubmissionDocument.section.image.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 manageable, 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())"/>
<xpath value="@value|f:*|h:div"/>
<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()"/>
<xpath
value="exists(f:extension)!=exists(f:*[starts-with(local-name(.), "value")])"/>
<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="ProductSubmissionDocument.section.image.modifierExtension">
<path
value="ProductSubmissionDocument.section.image.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 manageable, 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/R4B/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())"/>
<xpath value="@value|f:*|h:div"/>
<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()"/>
<xpath
value="exists(f:extension)!=exists(f:*[starts-with(local-name(.), "value")])"/>
<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="ProductSubmissionDocument.section.image.name">
<path value="ProductSubmissionDocument.section.image.name"/>
<short value="Image Title"/>
<definition value="Title of the image."/>
<min value="1"/>
<max value="1"/>
<base>
<path value="ProductSubmissionDocument.section.image.name"/>
<min value="1"/>
<max value="1"/>
</base>
<type>
<code value="string"/>
</type>
</element>
<element id="ProductSubmissionDocument.section.image.reference">
<path value="ProductSubmissionDocument.section.image.reference"/>
<short value="Image Reference"/>
<definition
value="Reference, either local or remote, to the image data."/>
<min value="1"/>
<max value="1"/>
<base>
<path value="ProductSubmissionDocument.section.image.reference"/>
<min value="1"/>
<max value="1"/>
</base>
<type>
<code value="url"/>
</type>
</element>
<element id="ProductSubmissionDocument.section.product">
<path value="ProductSubmissionDocument.section.product"/>
<short value="Section Product Information"/>
<definition
value="The complete definition of a medication being submitted in this document."/>
<min value="0"/>
<max value="*"/>
<base>
<path value="ProductSubmissionDocument.section.product"/>
<min value="0"/>
<max value="*"/>
</base>
<type>
<code
value="http://hl7.org/fhir/us/spl/StructureDefinition/SubmittedMedicationLogicalModel"/>
</type>
</element>
<element id="ProductSubmissionDocument.section.subsection">
<path value="ProductSubmissionDocument.section.subsection"/>
<short value="subsection"/>
<definition value="subsection"/>
<min value="0"/>
<max value="*"/>
<base>
<path value="ProductSubmissionDocument.section.subsection"/>
<min value="0"/>
<max value="*"/>
</base>
<contentReference
value="http://hl7.org/fhir/us/spl/StructureDefinition/ProductSubmissionDocumentLogicalModel#ProductSubmissionDocument.section"/>
<type>
<code value="BackboneElement"/>
</type>
</element>
</snapshot>
<differential>
<element id="ProductSubmissionDocument">
<path value="ProductSubmissionDocument"/>
<short value="Product Submission Document Logical Model"/>
<definition
value="A document that contains information about a product being submitted for approval to the FDA."/>
</element>
<element id="ProductSubmissionDocument.identifier">
<path value="ProductSubmissionDocument.identifier"/>
<short value="Document Identifier"/>
<definition
value="A unique identifier of this specific Product Submission document."/>
<min value="1"/>
<max value="1"/>
<type>
<code value="string"/>
</type>
</element>
<element id="ProductSubmissionDocument.splVersion">
<path value="ProductSubmissionDocument.splVersion"/>
<short value="Document SPL Version"/>
<definition
value="A date reference to the SPL version being used for this document."/>
<min value="1"/>
<max value="1"/>
<type>
<code value="date"/>
</type>
</element>
<element id="ProductSubmissionDocument.submissionIdentifier">
<path value="ProductSubmissionDocument.submissionIdentifier"/>
<short value="Submission Identifier"/>
<definition
value="A unique identifier of the submission that remains constant across all versions/revisions of this document."/>
<min value="1"/>
<max value="1"/>
<type>
<code value="string"/>
</type>
</element>
<element id="ProductSubmissionDocument.versionNumber">
<path value="ProductSubmissionDocument.versionNumber"/>
<short value="Document Version Number"/>
<definition
value="An integer that provides a sequence to the versions of the submission document."/>
<min value="1"/>
<max value="1"/>
<type>
<code value="positiveInt"/>
</type>
</element>
<element id="ProductSubmissionDocument.type">
<path value="ProductSubmissionDocument.type"/>
<short value="Document Type"/>
<definition
value="A LOINC code that provides inforamtion on the Product Submission type."/>
<min value="1"/>
<max value="1"/>
<type>
<code value="CodeableConcept"/>
</type>
</element>
<element id="ProductSubmissionDocument.title">
<path value="ProductSubmissionDocument.title"/>
<short value="Document Title"/>
<definition value="The title for the document."/>
<min value="0"/>
<max value="1"/>
<type>
<code value="string"/>
</type>
</element>
<element id="ProductSubmissionDocument.labeler">
<path value="ProductSubmissionDocument.labeler"/>
<short value="Product Labeler"/>
<definition
value="Information about the labeler organization that authored the document."/>
<min value="1"/>
<max value="1"/>
<type>
<code value="BackboneElement"/>
</type>
</element>
<element id="ProductSubmissionDocument.labeler.dunsNumber">
<path value="ProductSubmissionDocument.labeler.dunsNumber"/>
<short value="Product Labeler DUNS Number"/>
<definition
value="The Duns & Broadstreet number for the labeler organization."/>
<min value="1"/>
<max value="1"/>
<type>
<code value="string"/>
</type>
</element>
<element id="ProductSubmissionDocument.labeler.name">
<path value="ProductSubmissionDocument.labeler.name"/>
<short value="Product Labeler Name"/>
<definition value="The name of the labeler organization."/>
<min value="1"/>
<max value="1"/>
<type>
<code value="string"/>
</type>
</element>
<element id="ProductSubmissionDocument.labeler.registrant">
<path value="ProductSubmissionDocument.labeler.registrant"/>
<short value="Product Labeler Registrant"/>
<definition
value="Information about the registrant organization associated with the labeler."/>
<min value="0"/>
<max value="1"/>
<type>
<code value="BackboneElement"/>
</type>
</element>
<element id="ProductSubmissionDocument.labeler.registrant.dunsNumber">
<path value="ProductSubmissionDocument.labeler.registrant.dunsNumber"/>
<short value="Registrant DUNS Number"/>
<definition
value="The Duns & Broadstreet number for the registrant organization."/>
<min value="1"/>
<max value="1"/>
<type>
<code value="string"/>
</type>
</element>
<element id="ProductSubmissionDocument.labeler.registrant.name">
<path value="ProductSubmissionDocument.labeler.registrant.name"/>
<short value="Registrant Name"/>
<definition value="The name of the registrant organization."/>
<min value="1"/>
<max value="1"/>
<type>
<code value="string"/>
</type>
</element>
<element id="ProductSubmissionDocument.labeler.registrant.establishment">
<path
value="ProductSubmissionDocument.labeler.registrant.establishment"/>
<short value="Product Establishment"/>
<definition
value="Information about the establishment organization associated with active or new marketed products."/>
<min value="1"/>
<max value="*"/>
<type>
<code value="BackboneElement"/>
</type>
</element>
<element
id="ProductSubmissionDocument.labeler.registrant.establishment.dunsNumber">
<path
value="ProductSubmissionDocument.labeler.registrant.establishment.dunsNumber"/>
<short value="Establishment DUNS Number"/>
<definition
value="The Duns & Broadstreet number for the establishment organization."/>
<min value="1"/>
<max value="1"/>
<type>
<code value="string"/>
</type>
</element>
<element
id="ProductSubmissionDocument.labeler.registrant.establishment.name">
<path
value="ProductSubmissionDocument.labeler.registrant.establishment.name"/>
<short value="Establishment Name"/>
<definition value="The name of the establishment organization."/>
<min value="1"/>
<max value="1"/>
<type>
<code value="string"/>
</type>
</element>
<element
id="ProductSubmissionDocument.labeler.registrant.establishment.businessOperation">
<path
value="ProductSubmissionDocument.labeler.registrant.establishment.businessOperation"/>
<short value="Establishment Business Operations"/>
<definition
value="Various business operations that the Establishment organization performs."/>
<min value="1"/>
<max value="*"/>
<type>
<code value="BackboneElement"/>
</type>
</element>
<element
id="ProductSubmissionDocument.labeler.registrant.establishment.businessOperation.code">
<path
value="ProductSubmissionDocument.labeler.registrant.establishment.businessOperation.code"/>
<short value="Business Operation Type"/>
<definition
value="A code representing the specific business operation that the Establishment organization can perform."/>
<min value="1"/>
<max value="1"/>
<type>
<code value="CodeableConcept"/>
</type>
</element>
<element
id="ProductSubmissionDocument.labeler.registrant.establishment.businessOperation.productNDC">
<path
value="ProductSubmissionDocument.labeler.registrant.establishment.businessOperation.productNDC"/>
<short value="Business Operation Product NDC"/>
<definition
value="The NDC code of the specific product that this business operation is about."/>
<min value="0"/>
<max value="1"/>
<type>
<code value="CodeableConcept"/>
</type>
</element>
<element id="ProductSubmissionDocument.relatedDocument">
<path value="ProductSubmissionDocument.relatedDocument"/>
<short value="Reference to Related Document"/>
<definition
value="Reference to other documents that contain relevant information about this product submission."/>
<min value="0"/>
<max value="*"/>
<type>
<code value="BackboneElement"/>
</type>
</element>
<element id="ProductSubmissionDocument.relatedDocument.identifier">
<path value="ProductSubmissionDocument.relatedDocument.identifier"/>
<short value="Related Document Identifier"/>
<definition value="A unique identifier of this related document."/>
<min value="1"/>
<max value="1"/>
<type>
<code value="string"/>
</type>
</element>
<element
id="ProductSubmissionDocument.relatedDocument.submissionIdentifier">
<path
value="ProductSubmissionDocument.relatedDocument.submissionIdentifier"/>
<short value="Related Document Submission Identifier"/>
<definition
value="A unique identifier of the submission of this related document."/>
<min value="1"/>
<max value="1"/>
<type>
<code value="string"/>
</type>
</element>
<element id="ProductSubmissionDocument.relatedDocument.versionNumber">
<path value="ProductSubmissionDocument.relatedDocument.versionNumber"/>
<short value="Related Document Version Number"/>
<definition
value="An integer that provides a sequence to the versions of the related document."/>
<min value="1"/>
<max value="1"/>
<type>
<code value="positiveInt"/>
</type>
</element>
<element id="ProductSubmissionDocument.section">
<path value="ProductSubmissionDocument.section"/>
<short value="Document Sections"/>
<definition
value="A logical grouping of Product Submission information."/>
<min value="1"/>
<max value="*"/>
<type>
<code value="BackboneElement"/>
</type>
</element>
<element id="ProductSubmissionDocument.section.identifier">
<path value="ProductSubmissionDocument.section.identifier"/>
<short value="Section Identifier"/>
<definition
value="An identifier for this section that can be used to reference it in the document."/>
<min value="1"/>
<max value="1"/>
<type>
<code value="string"/>
</type>
</element>
<element id="ProductSubmissionDocument.section.effectiveTime">
<path value="ProductSubmissionDocument.section.effectiveTime"/>
<short value="Section Effective Time"/>
<definition value="The date when this section was authored."/>
<min value="1"/>
<max value="1"/>
<type>
<code value="date"/>
</type>
</element>
<element id="ProductSubmissionDocument.section.type">
<path value="ProductSubmissionDocument.section.type"/>
<short value="Section Type"/>
<definition
value="A code that identifies the content conveyed in this section."/>
<min value="1"/>
<max value="1"/>
<type>
<code value="CodeableConcept"/>
</type>
</element>
<element id="ProductSubmissionDocument.section.title">
<path value="ProductSubmissionDocument.section.title"/>
<short value="Section Title"/>
<definition
value="A header for the content contained in this section."/>
<min value="0"/>
<max value="1"/>
<type>
<code value="string"/>
</type>
</element>
<element id="ProductSubmissionDocument.section.text">
<path value="ProductSubmissionDocument.section.text"/>
<short value="Section Text"/>
<definition value="The human readable content of this section."/>
<min value="0"/>
<max value="1"/>
<type>
<code value="xhtml"/>
</type>
</element>
<element id="ProductSubmissionDocument.section.highlights">
<path value="ProductSubmissionDocument.section.highlights"/>
<short value="Section Text Highlights"/>
<definition
value="Content that is not a complete rendering of the information in this section."/>
<min value="0"/>
<max value="1"/>
<type>
<code value="xhtml"/>
</type>
</element>
<element id="ProductSubmissionDocument.section.image">
<path value="ProductSubmissionDocument.section.image"/>
<short value="Section Images"/>
<definition
value="References to images that are used in the human readable content of this section."/>
<min value="0"/>
<max value="*"/>
<type>
<code value="BackboneElement"/>
</type>
</element>
<element id="ProductSubmissionDocument.section.image.name">
<path value="ProductSubmissionDocument.section.image.name"/>
<short value="Image Title"/>
<definition value="Title of the image."/>
<min value="1"/>
<max value="1"/>
<type>
<code value="string"/>
</type>
</element>
<element id="ProductSubmissionDocument.section.image.reference">
<path value="ProductSubmissionDocument.section.image.reference"/>
<short value="Image Reference"/>
<definition
value="Reference, either local or remote, to the image data."/>
<min value="1"/>
<max value="1"/>
<type>
<code value="url"/>
</type>
</element>
<element id="ProductSubmissionDocument.section.product">
<path value="ProductSubmissionDocument.section.product"/>
<short value="Section Product Information"/>
<definition
value="The complete definition of a medication being submitted in this document."/>
<min value="0"/>
<max value="*"/>
<type>
<code
value="http://hl7.org/fhir/us/spl/StructureDefinition/SubmittedMedicationLogicalModel"/>
</type>
</element>
<element id="ProductSubmissionDocument.section.subsection">
<path value="ProductSubmissionDocument.section.subsection"/>
<short value="subsection"/>
<definition value="subsection"/>
<min value="0"/>
<max value="*"/>
<contentReference
value="http://hl7.org/fhir/us/spl/StructureDefinition/ProductSubmissionDocumentLogicalModel#ProductSubmissionDocument.section"/>
<type>
<code value="BackboneElement"/>
</type>
</element>
</differential>
</StructureDefinition>
IG © 2020+ HL7 International / Biomedical Research and Regulation. Package hl7.fhir.us.spl#0.1.0 based on FHIR 4.3.0. Generated 2024-05-16
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