UMC IDMP Request and Publish API
0.1.0 - CI Build

UMC IDMP Request and Publish API, published by Uppsala Monitoring Centre. 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/Uppsala-Monitoring-Centre/WHO-UMC-IDMP-Service/ and changes regularly. See the Directory of published versions

## Resource Profile: RegulatedAuthorizationWhoPhpRequest - XML Profile

Active as of 2025-11-19

XML representation of the RegulatedAuthorization-who-php resource profile.

Raw xml | Download

    <StructureDefinition xmlns="http://hl7.org/fhir">
      <id value="RegulatedAuthorization-who-php"/>
      <text>
        <status value="extensions"/>
        <div xmlns="http://www.w3.org/1999/xhtml"><p class="res-header-id"><b>Generated Narrative: StructureDefinition RegulatedAuthorization-who-php</b></p><a name="RegulatedAuthorization-who-php"> </a><a name="hcRegulatedAuthorization-who-php"> </a><table border="0" cellpadding="0" cellspacing="0" style="border: 0px #F0F0F0 solid; font-size: 11px; font-family: verdana; vertical-align: top;"><tr style="border: 1px #F0F0F0 solid; font-size: 11px; font-family: verdana; vertical-align: top"><th style="vertical-align: top; text-align : var(--ig-left,left); background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; padding-top: 3px; padding-bottom: 3px" class="hierarchy"><a href="https://build.fhir.org/ig/FHIR/ig-guidance/readingIgs.html#table-views" title="The logical name of the element">Name</a></th><th style="vertical-align: top; text-align : var(--ig-left,left); background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; padding-top: 3px; padding-bottom: 3px" class="hierarchy"><a href="https://build.fhir.org/ig/FHIR/ig-guidance/readingIgs.html#table-views" title="Information about the use of the element">Flags</a></th><th style="vertical-align: top; text-align : var(--ig-left,left); background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; padding-top: 3px; padding-bottom: 3px" class="hierarchy"><a href="https://build.fhir.org/ig/FHIR/ig-guidance/readingIgs.html#table-views" title="Minimum and Maximum # of times the element can appear in the instance">Card.</a></th><th style="vertical-align: top; text-align : var(--ig-left,left); background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; padding-top: 3px; padding-bottom: 3px; width: 100px" class="hierarchy"><a href="https://build.fhir.org/ig/FHIR/ig-guidance/readingIgs.html#table-views" title="Reference to the type of the element">Type</a></th><th style="vertical-align: top; text-align : var(--ig-left,left); background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; padding-top: 3px; padding-bottom: 3px" class="hierarchy"><a href="https://build.fhir.org/ig/FHIR/ig-guidance/readingIgs.html#table-views" title="Additional information about the element">Description &amp; Constraints</a><span style="float: right"><a href="https://build.fhir.org/ig/FHIR/ig-guidance/readingIgs.html#table-views" title="Legend for this format"><img src="data:image/png;base64, " alt="doco" style="background-color: inherit"/></a></span></th></tr><tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white"><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck1.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_resource.png" alt="." style="background-color: white; background-color: inherit" title="Resource" class="hierarchy"/> <a href="StructureDefinition-RegulatedAuthorization-who-php-definitions.html#RegulatedAuthorization">RegulatedAuthorization</a><a name="RegulatedAuthorization"> </a></td><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><span style="opacity: 0.5">0</span><span style="opacity: 0.5">..</span><span style="opacity: 0.5">*</span></td><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="http://hl7.org/fhir/R5/regulatedauthorization.html">RegulatedAuthorization</a></td><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><span style="opacity: 0.5">Regulatory approval, clearance or licencing related to a regulated product, treatment, facility or activity e.g. Market Authorization for a Medicinal Product</span></td></tr>
    <tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7"><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck10.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_reference.png" alt="." style="background-color: #F7F7F7; background-color: inherit" title="Reference to another Resource" class="hierarchy"/> <a href="StructureDefinition-RegulatedAuthorization-who-php-definitions.html#RegulatedAuthorization.subject">subject</a><a name="RegulatedAuthorization.subject"> </a></td><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">1..1</td><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="http://hl7.org/fhir/R5/references.html">Reference</a>(<a href="StructureDefinition-MedicinalProductDefinition-who-php-req.html">MedicinalProductDefinition for PhPID request</a>)</td><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><span style="opacity: 0.5">The product type, treatment, facility or activity that is being authorized</span></td></tr>
    <tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white"><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck00.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin_end.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_element.gif" alt="." style="background-color: white; background-color: inherit" title="Element" class="hierarchy"/> <a href="StructureDefinition-RegulatedAuthorization-who-php-definitions.html#RegulatedAuthorization.holder">holder</a><a name="RegulatedAuthorization.holder"> </a></td><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">1..<span style="opacity: 0.5">1</span></td><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="http://hl7.org/fhir/R5/references.html">Reference</a>(<a style="opacity: 0.5; opacity: 0.5" href="http://hl7.org/fhir/R5/organization.html">Organization</a>)</td><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><span style="opacity: 0.5">The organization that has been granted this authorization, by the regulator</span></td></tr>
    <tr><td colspan="5" class="hierarchy"><br/><a href="https://build.fhir.org/ig/FHIR/ig-guidance/readingIgs.html#table-views" title="Legend for this format"><img src="data:image/png;base64, " alt="doco" style="background-color: inherit"/> Documentation for this format</a></td></tr></table></div>
      </text>
      <url
           value="http://who-umc.org/idmp/StructureDefinition/RegulatedAuthorization-who-php"/>
      <version value="0.1.0"/>
      <name value="RegulatedAuthorizationWhoPhpRequest"/>
      <title value="Regulated Authorization"/>
      <status value="active"/>
      <date value="2025-11-19T07:03:36+00:00"/>
      <publisher value="Uppsala Monitoring Centre"/>
      <contact>
        <name value="Uppsala Monitoring Centre"/>
        <telecom>
          <system value="url"/>
          <value value="http://www.who-umc.org"/>
        </telecom>
      </contact>
      <contact>
        <name value="Uppsala Monitoring Centre"/>
        <telecom>
          <system value="url"/>
          <value value="http://www.who-umc.org"/>
        </telecom>
      </contact>
      <description
                   value="RegulatedAuthorization is a resource covering the authorization of a type of regulated product, treatment, facility or activity"/>
      <jurisdiction>
        <coding>
          <system value="http://unstats.un.org/unsd/methods/m49/m49.htm"/>
          <code value="001"/>
          <display value="World"/>
        </coding>
      </jurisdiction>
      <fhirVersion value="5.0.0"/>
      <mapping>
        <identity value="w5"/>
        <uri value="http://hl7.org/fhir/fivews"/>
        <name value="FiveWs Pattern Mapping"/>
      </mapping>
      <mapping>
        <identity value="idmp"/>
        <uri value="https://www.iso.org/obp/ui/#iso:std:iso:11615"/>
        <name value="IDMP Mapping"/>
      </mapping>
      <mapping>
        <identity value="rim"/>
        <uri value="http://hl7.org/v3"/>
        <name value="RIM Mapping"/>
      </mapping>
      <kind value="resource"/>
      <abstract value="false"/>
      <type value="RegulatedAuthorization"/>
      <baseDefinition
                      value="http://hl7.org/fhir/StructureDefinition/RegulatedAuthorization"/>
      <derivation value="constraint"/>
      <snapshot>
        <extension
                   url="http://hl7.org/fhir/tools/StructureDefinition/snapshot-base-version">
          <valueString value="5.0.0"/>
        </extension>
        <element id="RegulatedAuthorization">
          <path value="RegulatedAuthorization"/>
          <short
                 value="Regulatory approval, clearance or licencing related to a regulated product, treatment, facility or activity e.g. Market Authorization for a Medicinal Product"/>
          <definition
                      value="Regulatory approval, clearance or licencing related to a regulated product, treatment, facility or activity that is cited in a guidance, regulation, rule or legislative act. An example is Market Authorization relating to a Medicinal Product."/>
          <min value="0"/>
          <max value="*"/>
          <base>
            <path value="RegulatedAuthorization"/>
            <min value="0"/>
            <max value="*"/>
          </base>
          <constraint>
            <key value="dom-2"/>
            <severity value="error"/>
            <human
                   value="If the resource is contained in another resource, it SHALL NOT contain nested Resources"/>
            <expression value="contained.contained.empty()"/>
            <source
                    value="http://hl7.org/fhir/StructureDefinition/DomainResource"/>
          </constraint>
          <constraint>
            <key value="dom-3"/>
            <severity value="error"/>
            <human
                   value="If the resource is contained in another resource, it SHALL be referred to from elsewhere in the resource or SHALL refer to the containing resource"/>
            <expression
                        value="contained.where((('#'+id in (%resource.descendants().reference | %resource.descendants().ofType(canonical) | %resource.descendants().ofType(uri) | %resource.descendants().ofType(url))) or descendants().where(reference = '#').exists() or descendants().where(ofType(canonical) = '#').exists() or descendants().where(ofType(canonical) = '#').exists()).not()).trace('unmatched', id).empty()"/>
            <source
                    value="http://hl7.org/fhir/StructureDefinition/DomainResource"/>
          </constraint>
          <constraint>
            <key value="dom-4"/>
            <severity value="error"/>
            <human
                   value="If a resource is contained in another resource, it SHALL NOT have a meta.versionId or a meta.lastUpdated"/>
            <expression
                        value="contained.meta.versionId.empty() and contained.meta.lastUpdated.empty()"/>
            <source
                    value="http://hl7.org/fhir/StructureDefinition/DomainResource"/>
          </constraint>
          <constraint>
            <key value="dom-5"/>
            <severity value="error"/>
            <human
                   value="If a resource is contained in another resource, it SHALL NOT have a security label"/>
            <expression value="contained.meta.security.empty()"/>
            <source
                    value="http://hl7.org/fhir/StructureDefinition/DomainResource"/>
          </constraint>
          <constraint>
            <extension
                       url="http://hl7.org/fhir/StructureDefinition/elementdefinition-bestpractice">
              <valueBoolean value="true"/>
            </extension>
            <extension
                       url="http://hl7.org/fhir/StructureDefinition/elementdefinition-bestpractice-explanation">
              <valueMarkdown
                             value="When a resource has no narrative, only systems that fully understand the data can display the resource to a human safely. Including a human readable representation in the resource makes for a much more robust eco-system and cheaper handling of resources by intermediary systems. Some ecosystems restrict distribution of resources to only those systems that do fully understand the resources, and as a consequence implementers may believe that the narrative is superfluous. However experience shows that such eco-systems often open up to new participants over time."/>
            </extension>
            <key value="dom-6"/>
            <severity value="warning"/>
            <human
                   value="A resource should have narrative for robust management"/>
            <expression value="text.`div`.exists()"/>
            <source
                    value="http://hl7.org/fhir/StructureDefinition/DomainResource"/>
          </constraint>
          <mustSupport value="false"/>
          <isModifier value="false"/>
          <isSummary value="false"/>
          <mapping>
            <identity value="rim"/>
            <map value="Entity, Role, or Act"/>
          </mapping>
          <mapping>
            <identity value="w5"/>
            <map value="administrative.medication"/>
          </mapping>
          <mapping>
            <identity value="idmp"/>
            <map value="Marketing Authorization, Clinical Trial Authorization"/>
          </mapping>
        </element>
        <element id="RegulatedAuthorization.id">
          <path value="RegulatedAuthorization.id"/>
          <short value="Logical id of this artifact"/>
          <definition
                      value="The logical id of the resource, as used in the URL for the resource. Once assigned, this value never changes."/>
          <comment
                   value="Within the context of the FHIR RESTful interactions, the resource has an id except for cases like the create and conditional update. Otherwise, the use of the resouce id depends on the given use case."/>
          <min value="0"/>
          <max value="1"/>
          <base>
            <path value="Resource.id"/>
            <min value="0"/>
            <max value="1"/>
          </base>
          <type>
            <extension
                       url="http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type">
              <valueUrl value="id"/>
            </extension>
            <code value="http://hl7.org/fhirpath/System.String"/>
          </type>
          <mustSupport value="false"/>
          <isModifier value="false"/>
          <isSummary value="true"/>
        </element>
        <element id="RegulatedAuthorization.meta">
          <path value="RegulatedAuthorization.meta"/>
          <short value="Metadata about the resource"/>
          <definition
                      value="The metadata about the resource. This is content that is maintained by the infrastructure. Changes to the content might not always be associated with version changes to the resource."/>
          <min value="0"/>
          <max value="1"/>
          <base>
            <path value="Resource.meta"/>
            <min value="0"/>
            <max value="1"/>
          </base>
          <type>
            <code value="Meta"/>
          </type>
          <constraint>
            <key value="ele-1"/>
            <severity value="error"/>
            <human value="All FHIR elements must have a @value or children"/>
            <expression
                        value="hasValue() or (children().count() &gt; id.count())"/>
            <source value="http://hl7.org/fhir/StructureDefinition/Element"/>
          </constraint>
          <mustSupport value="false"/>
          <isModifier value="false"/>
          <isSummary value="true"/>
        </element>
        <element id="RegulatedAuthorization.implicitRules">
          <path value="RegulatedAuthorization.implicitRules"/>
          <short value="A set of rules under which this content was created"/>
          <definition
                      value="A reference to a set of rules that were followed when the resource was constructed, and which must be understood when processing the content. Often, this is a reference to an implementation guide that defines the special rules along with other profiles etc."/>
          <comment
                   value="Asserting this rule set restricts the content to be only understood by a limited set of trading partners. This inherently limits the usefulness of the data in the long term. However, the existing health eco-system is highly fractured, and not yet ready to define, collect, and exchange data in a generally computable sense. Wherever possible, implementers and/or specification writers should avoid using this element. Often, when used, the URL is a reference to an implementation guide that defines these special rules as part of its narrative along with other profiles, value sets, etc."/>
          <min value="0"/>
          <max value="1"/>
          <base>
            <path value="Resource.implicitRules"/>
            <min value="0"/>
            <max value="1"/>
          </base>
          <type>
            <code value="uri"/>
          </type>
          <constraint>
            <key value="ele-1"/>
            <severity value="error"/>
            <human value="All FHIR elements must have a @value or children"/>
            <expression
                        value="hasValue() or (children().count() &gt; id.count())"/>
            <source value="http://hl7.org/fhir/StructureDefinition/Element"/>
          </constraint>
          <mustSupport value="false"/>
          <isModifier value="true"/>
          <isModifierReason
                            value="This element is labeled as a modifier because the implicit rules may provide additional knowledge about the resource that modifies its meaning or interpretation"/>
          <isSummary value="true"/>
        </element>
        <element id="RegulatedAuthorization.language">
          <path value="RegulatedAuthorization.language"/>
          <short value="Language of the resource content"/>
          <definition
                      value="The base language in which the resource is written."/>
          <comment
                   value="Language is provided to support indexing and accessibility (typically, services such as text to speech use the language tag). The html language tag in the narrative applies  to the narrative. The language tag on the resource may be used to specify the language of other presentations generated from the data in the resource. Not all the content has to be in the base language. The Resource.language should not be assumed to apply to the narrative automatically. If a language is specified, it should it also be specified on the div element in the html (see rules in HTML5 for information about the relationship between xml:lang and the html lang attribute)."/>
          <min value="0"/>
          <max value="1"/>
          <base>
            <path value="Resource.language"/>
            <min value="0"/>
            <max value="1"/>
          </base>
          <type>
            <code value="code"/>
          </type>
          <constraint>
            <key value="ele-1"/>
            <severity value="error"/>
            <human value="All FHIR elements must have a @value or children"/>
            <expression
                        value="hasValue() or (children().count() &gt; id.count())"/>
            <source value="http://hl7.org/fhir/StructureDefinition/Element"/>
          </constraint>
          <mustSupport value="false"/>
          <isModifier value="false"/>
          <isSummary value="false"/>
          <binding>
            <extension
                       url="http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName">
              <valueString value="Language"/>
            </extension>
            <strength value="required"/>
            <description value="IETF language tag for a human language"/>
            <valueSet value="http://hl7.org/fhir/ValueSet/all-languages|5.0.0"/>
            <additional>
              <purpose value="starter"/>
              <valueSet value="http://hl7.org/fhir/ValueSet/languages|5.0.0"/>
            </additional>
          </binding>
        </element>
        <element id="RegulatedAuthorization.text">
          <path value="RegulatedAuthorization.text"/>
          <short value="Text summary of the resource, for human interpretation"/>
          <definition
                      value="A human-readable narrative that contains a summary of the resource and can be used to represent the content of the resource to a human. The narrative need not encode all the structured data, but is required to contain sufficient detail to make it &quot;clinically safe&quot; for a human to just read the narrative. Resource definitions may define what content should be represented in the narrative to ensure clinical safety."/>
          <comment
                   value="Contained resources do not have a narrative. Resources that are not contained SHOULD have a narrative. In some cases, a resource may only have text with little or no additional discrete data (as long as all minOccurs=1 elements are satisfied).  This may be necessary for data from legacy systems where information is captured as a &quot;text blob&quot; or where text is additionally entered raw or narrated and encoded information is added later."/>
          <alias value="narrative"/>
          <alias value="html"/>
          <alias value="xhtml"/>
          <alias value="display"/>
          <min value="0"/>
          <max value="1"/>
          <base>
            <path value="DomainResource.text"/>
            <min value="0"/>
            <max value="1"/>
          </base>
          <type>
            <code value="Narrative"/>
          </type>
          <condition value="dom-6"/>
          <constraint>
            <key value="ele-1"/>
            <severity value="error"/>
            <human value="All FHIR elements must have a @value or children"/>
            <expression
                        value="hasValue() or (children().count() &gt; id.count())"/>
            <source value="http://hl7.org/fhir/StructureDefinition/Element"/>
          </constraint>
          <mustSupport value="false"/>
          <isModifier value="false"/>
          <isSummary value="false"/>
          <mapping>
            <identity value="rim"/>
            <map value="Act.text?"/>
          </mapping>
        </element>
        <element id="RegulatedAuthorization.contained">
          <path value="RegulatedAuthorization.contained"/>
          <short value="Contained, inline Resources"/>
          <definition
                      value="These resources do not have an independent existence apart from the resource that contains them - they cannot be identified independently, nor can they have their own independent transaction scope. This is allowed to be a Parameters resource if and only if it is referenced by a resource that provides context/meaning."/>
          <comment
                   value="This should never be done when the content can be identified properly, as once identification is lost, it is extremely difficult (and context dependent) to restore it again. Contained resources may have profiles and tags in their meta elements, but SHALL NOT have security labels."/>
          <alias value="inline resources"/>
          <alias value="anonymous resources"/>
          <alias value="contained resources"/>
          <min value="0"/>
          <max value="*"/>
          <base>
            <path value="DomainResource.contained"/>
            <min value="0"/>
            <max value="*"/>
          </base>
          <type>
            <code value="Resource"/>
          </type>
          <condition value="dom-2"/>
          <condition value="dom-4"/>
          <condition value="dom-3"/>
          <condition value="dom-5"/>
          <mustSupport value="false"/>
          <isModifier value="false"/>
          <isSummary value="false"/>
          <mapping>
            <identity value="rim"/>
            <map value="N/A"/>
          </mapping>
        </element>
        <element id="RegulatedAuthorization.extension">
          <path value="RegulatedAuthorization.extension"/>
          <short value="Additional content defined by implementations"/>
          <definition
                      value="May be used to represent additional information that is not part of the basic definition of the resource. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension."/>
          <comment
                   value="There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions.  The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone."/>
          <alias value="extensions"/>
          <alias value="user content"/>
          <min value="0"/>
          <max value="*"/>
          <base>
            <path value="DomainResource.extension"/>
            <min value="0"/>
            <max value="*"/>
          </base>
          <type>
            <code value="Extension"/>
          </type>
          <constraint>
            <key value="ele-1"/>
            <severity value="error"/>
            <human value="All FHIR elements must have a @value or children"/>
            <expression
                        value="hasValue() or (children().count() &gt; id.count())"/>
            <source value="http://hl7.org/fhir/StructureDefinition/Element"/>
          </constraint>
          <constraint>
            <key value="ext-1"/>
            <severity value="error"/>
            <human value="Must have either extensions or value[x], not both"/>
            <expression value="extension.exists() != value.exists()"/>
            <source value="http://hl7.org/fhir/StructureDefinition/Extension"/>
          </constraint>
          <mustSupport value="false"/>
          <isModifier value="false"/>
          <isSummary value="false"/>
          <mapping>
            <identity value="rim"/>
            <map value="N/A"/>
          </mapping>
        </element>
        <element id="RegulatedAuthorization.modifierExtension">
          <path value="RegulatedAuthorization.modifierExtension"/>
          <short value="Extensions that cannot be ignored"/>
          <definition
                      value="May be used to represent additional information that is not part of the basic definition of the resource and that modifies the understanding of the element that contains it and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer is allowed to define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.

    Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself)."/>
          <comment
                   value="There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions.  The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone."/>
          <requirements
                        value="Modifier extensions allow for extensions that *cannot* be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored.  This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the [definition of modifier extensions](http://hl7.org/fhir/R5/extensibility.html#modifierExtension)."/>
          <alias value="extensions"/>
          <alias value="user content"/>
          <min value="0"/>
          <max value="*"/>
          <base>
            <path value="DomainResource.modifierExtension"/>
            <min value="0"/>
            <max value="*"/>
          </base>
          <type>
            <code value="Extension"/>
          </type>
          <constraint>
            <key value="ele-1"/>
            <severity value="error"/>
            <human value="All FHIR elements must have a @value or children"/>
            <expression
                        value="hasValue() or (children().count() &gt; id.count())"/>
            <source value="http://hl7.org/fhir/StructureDefinition/Element"/>
          </constraint>
          <constraint>
            <key value="ext-1"/>
            <severity value="error"/>
            <human value="Must have either extensions or value[x], not both"/>
            <expression value="extension.exists() != value.exists()"/>
            <source value="http://hl7.org/fhir/StructureDefinition/Extension"/>
          </constraint>
          <mustSupport value="false"/>
          <isModifier value="true"/>
          <isModifierReason
                            value="Modifier extensions are expected to modify the meaning or interpretation of the resource that contains them"/>
          <isSummary value="true"/>
          <mapping>
            <identity value="rim"/>
            <map value="N/A"/>
          </mapping>
        </element>
        <element id="RegulatedAuthorization.identifier">
          <path value="RegulatedAuthorization.identifier"/>
          <short
                 value="Business identifier for the authorization, typically assigned by the authorizing body"/>
          <definition
                      value="Business identifier for the authorization, typically assigned by the authorizing body."/>
          <min value="0"/>
          <max value="*"/>
          <base>
            <path value="RegulatedAuthorization.identifier"/>
            <min value="0"/>
            <max value="*"/>
          </base>
          <type>
            <code value="Identifier"/>
          </type>
          <constraint>
            <key value="ele-1"/>
            <severity value="error"/>
            <human value="All FHIR elements must have a @value or children"/>
            <expression
                        value="hasValue() or (children().count() &gt; id.count())"/>
            <source value="http://hl7.org/fhir/StructureDefinition/Element"/>
          </constraint>
          <mustSupport value="false"/>
          <isModifier value="false"/>
          <isSummary value="true"/>
          <mapping>
            <identity value="w5"/>
            <map value="FiveWs.class"/>
          </mapping>
          <mapping>
            <identity value="idmp"/>
            <map value="Marketing Authorization.Marketing Authorization Number"/>
          </mapping>
        </element>
        <element id="RegulatedAuthorization.subject">
          <path value="RegulatedAuthorization.subject"/>
          <short
                 value="The product type, treatment, facility or activity that is being authorized"/>
          <definition
                      value="The product type, treatment, facility or activity that is being authorized."/>
          <min value="1"/>
          <max value="1"/>
          <base>
            <path value="RegulatedAuthorization.subject"/>
            <min value="0"/>
            <max value="*"/>
          </base>
          <type>
            <code value="Reference"/>
            <targetProfile
                           value="http://who-umc.org/idmp/StructureDefinition/MedicinalProductDefinition-who-php-req"/>
          </type>
          <constraint>
            <key value="ele-1"/>
            <severity value="error"/>
            <human value="All FHIR elements must have a @value or children"/>
            <expression
                        value="hasValue() or (children().count() &gt; id.count())"/>
            <source value="http://hl7.org/fhir/StructureDefinition/Element"/>
          </constraint>
          <mustSupport value="false"/>
          <isModifier value="false"/>
          <isSummary value="true"/>
          <mapping>
            <identity value="idmp"/>
            <map
                 value="(the link to Medicinal Product or Packaged Medicinal Product)"/>
          </mapping>
        </element>
        <element id="RegulatedAuthorization.type">
          <path value="RegulatedAuthorization.type"/>
          <short
                 value="Overall type of this authorization, for example drug marketing approval, orphan drug designation"/>
          <definition
                      value="Overall type of this authorization, for example drug marketing approval, orphan drug designation."/>
          <min value="0"/>
          <max value="1"/>
          <base>
            <path value="RegulatedAuthorization.type"/>
            <min value="0"/>
            <max value="1"/>
          </base>
          <type>
            <code value="CodeableConcept"/>
          </type>
          <constraint>
            <key value="ele-1"/>
            <severity value="error"/>
            <human value="All FHIR elements must have a @value or children"/>
            <expression
                        value="hasValue() or (children().count() &gt; id.count())"/>
            <source value="http://hl7.org/fhir/StructureDefinition/Element"/>
          </constraint>
          <mustSupport value="false"/>
          <isModifier value="false"/>
          <isSummary value="true"/>
          <binding>
            <extension
                       url="http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName">
              <valueString value="RegulatedAuthorizationType"/>
            </extension>
            <strength value="example"/>
            <description value="Overall type of this authorization."/>
            <valueSet
                      value="http://hl7.org/fhir/ValueSet/regulated-authorization-type|5.0.0"/>
          </binding>
          <mapping>
            <identity value="idmp"/>
            <map value="n/a"/>
          </mapping>
        </element>
        <element id="RegulatedAuthorization.description">
          <path value="RegulatedAuthorization.description"/>
          <short value="General textual supporting information"/>
          <definition value="General textual supporting information."/>
          <min value="0"/>
          <max value="1"/>
          <base>
            <path value="RegulatedAuthorization.description"/>
            <min value="0"/>
            <max value="1"/>
          </base>
          <type>
            <code value="markdown"/>
          </type>
          <constraint>
            <key value="ele-1"/>
            <severity value="error"/>
            <human value="All FHIR elements must have a @value or children"/>
            <expression
                        value="hasValue() or (children().count() &gt; id.count())"/>
            <source value="http://hl7.org/fhir/StructureDefinition/Element"/>
          </constraint>
          <mustSupport value="false"/>
          <isModifier value="false"/>
          <isSummary value="true"/>
          <mapping>
            <identity value="idmp"/>
            <map value="n/a"/>
          </mapping>
        </element>
        <element id="RegulatedAuthorization.region">
          <path value="RegulatedAuthorization.region"/>
          <short
                 value="The territory in which the authorization has been granted"/>
          <definition
                      value="The territory (e.g., country, jurisdiction etc.) in which the authorization has been granted."/>
          <min value="0"/>
          <max value="*"/>
          <base>
            <path value="RegulatedAuthorization.region"/>
            <min value="0"/>
            <max value="*"/>
          </base>
          <type>
            <code value="CodeableConcept"/>
          </type>
          <constraint>
            <key value="ele-1"/>
            <severity value="error"/>
            <human value="All FHIR elements must have a @value or children"/>
            <expression
                        value="hasValue() or (children().count() &gt; id.count())"/>
            <source value="http://hl7.org/fhir/StructureDefinition/Element"/>
          </constraint>
          <mustSupport value="false"/>
          <isModifier value="false"/>
          <isSummary value="true"/>
          <binding>
            <extension
                       url="http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName">
              <valueString value="Jurisdiction"/>
            </extension>
            <strength value="example"/>
            <description value="Jurisdiction codes"/>
            <valueSet value="http://hl7.org/fhir/ValueSet/jurisdiction|5.0.0"/>
          </binding>
          <mapping>
            <identity value="idmp"/>
            <map value="Marketing Authorization.Country"/>
          </mapping>
        </element>
        <element id="RegulatedAuthorization.status">
          <path value="RegulatedAuthorization.status"/>
          <short
                 value="The status that is authorised e.g. approved. Intermediate states can be tracked with cases and applications"/>
          <definition
                      value="The status that is authorised e.g. approved. Intermediate states and actions can be tracked with cases and applications."/>
          <min value="0"/>
          <max value="1"/>
          <base>
            <path value="RegulatedAuthorization.status"/>
            <min value="0"/>
            <max value="1"/>
          </base>
          <type>
            <code value="CodeableConcept"/>
          </type>
          <constraint>
            <key value="ele-1"/>
            <severity value="error"/>
            <human value="All FHIR elements must have a @value or children"/>
            <expression
                        value="hasValue() or (children().count() &gt; id.count())"/>
            <source value="http://hl7.org/fhir/StructureDefinition/Element"/>
          </constraint>
          <mustSupport value="false"/>
          <isModifier value="false"/>
          <isSummary value="true"/>
          <binding>
            <extension
                       url="http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName">
              <valueString value="PublicationStatus"/>
            </extension>
            <strength value="preferred"/>
            <description value="The lifecycle status of an artifact."/>
            <valueSet
                      value="http://hl7.org/fhir/ValueSet/publication-status|5.0.0"/>
          </binding>
          <mapping>
            <identity value="idmp"/>
            <map value="Marketing Authorization.Authorization Status"/>
          </mapping>
        </element>
        <element id="RegulatedAuthorization.statusDate">
          <path value="RegulatedAuthorization.statusDate"/>
          <short value="The date at which the current status was assigned"/>
          <definition value="The date at which the current status was assigned."/>
          <min value="0"/>
          <max value="1"/>
          <base>
            <path value="RegulatedAuthorization.statusDate"/>
            <min value="0"/>
            <max value="1"/>
          </base>
          <type>
            <code value="dateTime"/>
          </type>
          <constraint>
            <key value="ele-1"/>
            <severity value="error"/>
            <human value="All FHIR elements must have a @value or children"/>
            <expression
                        value="hasValue() or (children().count() &gt; id.count())"/>
            <source value="http://hl7.org/fhir/StructureDefinition/Element"/>
          </constraint>
          <mustSupport value="false"/>
          <isModifier value="false"/>
          <isSummary value="true"/>
          <mapping>
            <identity value="idmp"/>
            <map value="Marketing Authorization.Authorization Status Date"/>
          </mapping>
        </element>
        <element id="RegulatedAuthorization.validityPeriod">
          <path value="RegulatedAuthorization.validityPeriod"/>
          <short
                 value="The time period in which the regulatory approval etc. is in effect, e.g. a Marketing Authorization includes the date of authorization and/or expiration date"/>
          <definition
                      value="The time period in which the regulatory approval, clearance or licencing is in effect. As an example, a Marketing Authorization includes the date of authorization and/or an expiration date."/>
          <min value="0"/>
          <max value="1"/>
          <base>
            <path value="RegulatedAuthorization.validityPeriod"/>
            <min value="0"/>
            <max value="1"/>
          </base>
          <type>
            <code value="Period"/>
          </type>
          <constraint>
            <key value="ele-1"/>
            <severity value="error"/>
            <human value="All FHIR elements must have a @value or children"/>
            <expression
                        value="hasValue() or (children().count() &gt; id.count())"/>
            <source value="http://hl7.org/fhir/StructureDefinition/Element"/>
          </constraint>
          <mustSupport value="false"/>
          <isModifier value="false"/>
          <isSummary value="true"/>
          <mapping>
            <identity value="idmp"/>
            <map
                 value="Marketing Authorization.Validity Period Start, Marketing Authorization.Validity Period End"/>
          </mapping>
        </element>
        <element id="RegulatedAuthorization.indication">
          <path value="RegulatedAuthorization.indication"/>
          <short
                 value="Condition for which the use of the regulated product applies"/>
          <definition
                      value="Condition for which the use of the regulated product applies."/>
          <min value="0"/>
          <max value="*"/>
          <base>
            <path value="RegulatedAuthorization.indication"/>
            <min value="0"/>
            <max value="*"/>
          </base>
          <type>
            <code value="CodeableReference"/>
            <targetProfile
                           value="http://hl7.org/fhir/StructureDefinition/ClinicalUseDefinition|5.0.0"/>
          </type>
          <constraint>
            <key value="ele-1"/>
            <severity value="error"/>
            <human value="All FHIR elements must have a @value or children"/>
            <expression
                        value="hasValue() or (children().count() &gt; id.count())"/>
            <source value="http://hl7.org/fhir/StructureDefinition/Element"/>
          </constraint>
          <mustSupport value="false"/>
          <isModifier value="false"/>
          <isSummary value="true"/>
          <mapping>
            <identity value="idmp"/>
            <map value="n/a"/>
          </mapping>
        </element>
        <element id="RegulatedAuthorization.intendedUse">
          <path value="RegulatedAuthorization.intendedUse"/>
          <short
                 value="The intended use of the product, e.g. prevention, treatment"/>
          <definition
                      value="The intended use of the product, e.g. prevention, treatment, diagnosis."/>
          <min value="0"/>
          <max value="1"/>
          <base>
            <path value="RegulatedAuthorization.intendedUse"/>
            <min value="0"/>
            <max value="1"/>
          </base>
          <type>
            <code value="CodeableConcept"/>
          </type>
          <constraint>
            <key value="ele-1"/>
            <severity value="error"/>
            <human value="All FHIR elements must have a @value or children"/>
            <expression
                        value="hasValue() or (children().count() &gt; id.count())"/>
            <source value="http://hl7.org/fhir/StructureDefinition/Element"/>
          </constraint>
          <mustSupport value="false"/>
          <isModifier value="false"/>
          <isSummary value="true"/>
          <binding>
            <extension
                       url="http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName">
              <valueString value="ProductIntendedUse"/>
            </extension>
            <strength value="preferred"/>
            <description value="The overall intended use of a product."/>
            <valueSet
                      value="http://hl7.org/fhir/ValueSet/product-intended-use|5.0.0"/>
          </binding>
          <mapping>
            <identity value="idmp"/>
            <map value="n/a"/>
          </mapping>
        </element>
        <element id="RegulatedAuthorization.basis">
          <path value="RegulatedAuthorization.basis"/>
          <short
                 value="The legal/regulatory framework or reasons under which this authorization is granted"/>
          <definition
                      value="The legal or regulatory framework against which this authorization is granted, or other reasons for it."/>
          <min value="0"/>
          <max value="*"/>
          <base>
            <path value="RegulatedAuthorization.basis"/>
            <min value="0"/>
            <max value="*"/>
          </base>
          <type>
            <code value="CodeableConcept"/>
          </type>
          <constraint>
            <key value="ele-1"/>
            <severity value="error"/>
            <human value="All FHIR elements must have a @value or children"/>
            <expression
                        value="hasValue() or (children().count() &gt; id.count())"/>
            <source value="http://hl7.org/fhir/StructureDefinition/Element"/>
          </constraint>
          <mustSupport value="false"/>
          <isModifier value="false"/>
          <isSummary value="true"/>
          <binding>
            <extension
                       url="http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName">
              <valueString value="RegulatedAuthorizationBasis"/>
            </extension>
            <strength value="example"/>
            <description
                         value="A legal or regulatory framework against which an authorization is granted, or other reasons for it."/>
            <valueSet
                      value="http://hl7.org/fhir/ValueSet/regulated-authorization-basis|5.0.0"/>
          </binding>
          <mapping>
            <identity value="idmp"/>
            <map value="Marketing Authorization.Status Reasons.Legal Grounds"/>
          </mapping>
        </element>
        <element id="RegulatedAuthorization.holder">
          <path value="RegulatedAuthorization.holder"/>
          <short
                 value="The organization that has been granted this authorization, by the regulator"/>
          <definition
                      value="The organization that has been granted this authorization, by some authoritative body (the 'regulator')."/>
          <min value="1"/>
          <max value="1"/>
          <base>
            <path value="RegulatedAuthorization.holder"/>
            <min value="0"/>
            <max value="1"/>
          </base>
          <type>
            <code value="Reference"/>
            <targetProfile
                           value="http://hl7.org/fhir/StructureDefinition/Organization|5.0.0"/>
          </type>
          <constraint>
            <key value="ele-1"/>
            <severity value="error"/>
            <human value="All FHIR elements must have a @value or children"/>
            <expression
                        value="hasValue() or (children().count() &gt; id.count())"/>
            <source value="http://hl7.org/fhir/StructureDefinition/Element"/>
          </constraint>
          <mustSupport value="false"/>
          <isModifier value="false"/>
          <isSummary value="true"/>
          <mapping>
            <identity value="idmp"/>
            <map
                 value="Marketing Authorization.Marketing Authorization Holder (Organisation)"/>
          </mapping>
        </element>
        <element id="RegulatedAuthorization.regulator">
          <path value="RegulatedAuthorization.regulator"/>
          <short
                 value="The regulatory authority or authorizing body granting the authorization"/>
          <definition
                      value="The regulatory authority or authorizing body granting the authorization. For example, European Medicines Agency (EMA), Food and Drug Administration (FDA), Health Canada (HC), etc."/>
          <min value="0"/>
          <max value="1"/>
          <base>
            <path value="RegulatedAuthorization.regulator"/>
            <min value="0"/>
            <max value="1"/>
          </base>
          <type>
            <code value="Reference"/>
            <targetProfile
                           value="http://hl7.org/fhir/StructureDefinition/Organization|5.0.0"/>
          </type>
          <constraint>
            <key value="ele-1"/>
            <severity value="error"/>
            <human value="All FHIR elements must have a @value or children"/>
            <expression
                        value="hasValue() or (children().count() &gt; id.count())"/>
            <source value="http://hl7.org/fhir/StructureDefinition/Element"/>
          </constraint>
          <mustSupport value="false"/>
          <isModifier value="false"/>
          <isSummary value="true"/>
          <mapping>
            <identity value="idmp"/>
            <map
                 value="Marketing Authorization.Medicines Regulatory Agency (Organisation)"/>
          </mapping>
        </element>
        <element id="RegulatedAuthorization.attachedDocument">
          <path value="RegulatedAuthorization.attachedDocument"/>
          <short
                 value="Additional information or supporting documentation about the authorization"/>
          <definition
                      value="Additional information or supporting documentation about the authorization."/>
          <min value="0"/>
          <max value="*"/>
          <base>
            <path value="RegulatedAuthorization.attachedDocument"/>
            <min value="0"/>
            <max value="*"/>
          </base>
          <type>
            <code value="Reference"/>
            <targetProfile
                           value="http://hl7.org/fhir/StructureDefinition/DocumentReference|5.0.0"/>
          </type>
          <constraint>
            <key value="ele-1"/>
            <severity value="error"/>
            <human value="All FHIR elements must have a @value or children"/>
            <expression
                        value="hasValue() or (children().count() &gt; id.count())"/>
            <source value="http://hl7.org/fhir/StructureDefinition/Element"/>
          </constraint>
          <mustSupport value="false"/>
          <isModifier value="false"/>
          <isSummary value="true"/>
          <mapping>
            <identity value="idmp"/>
            <map value="n/a"/>
          </mapping>
        </element>
        <element id="RegulatedAuthorization.case">
          <path value="RegulatedAuthorization.case"/>
          <short
                 value="The case or regulatory procedure for granting or amending a regulated authorization. Note: This area is subject to ongoing review and the workgroup is seeking implementer feedback on its use (see link at bottom of page)"/>
          <definition
                      value="The case or regulatory procedure for granting or amending a regulated authorization. An authorization is granted in response to submissions/applications by those seeking authorization. A case is the administrative process that deals with the application(s) that relate to this and assesses them. Note: This area is subject to ongoing review and the workgroup is seeking implementer feedback on its use (see link at bottom of page)."/>
          <min value="0"/>
          <max value="1"/>
          <base>
            <path value="RegulatedAuthorization.case"/>
            <min value="0"/>
            <max value="1"/>
          </base>
          <type>
            <code value="BackboneElement"/>
          </type>
          <constraint>
            <key value="ele-1"/>
            <severity value="error"/>
            <human value="All FHIR elements must have a @value or children"/>
            <expression
                        value="hasValue() or (children().count() &gt; id.count())"/>
            <source value="http://hl7.org/fhir/StructureDefinition/Element"/>
          </constraint>
          <mustSupport value="false"/>
          <isModifier value="false"/>
          <isSummary value="true"/>
          <mapping>
            <identity value="idmp"/>
            <map
                 value="Marketing Authorization.Marketing Authorization Procedure, Marketing Authorization Procedure.Marketing Authorization Application"/>
          </mapping>
        </element>
        <element id="RegulatedAuthorization.case.id">
          <path value="RegulatedAuthorization.case.id"/>
          <representation value="xmlAttr"/>
          <short value="Unique id for inter-element referencing"/>
          <definition
                      value="Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces."/>
          <min value="0"/>
          <max value="1"/>
          <base>
            <path value="Element.id"/>
            <min value="0"/>
            <max value="1"/>
          </base>
          <type>
            <extension
                       url="http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type">
              <valueUrl value="string"/>
            </extension>
            <code value="http://hl7.org/fhirpath/System.String"/>
          </type>
          <condition value="ele-1"/>
          <isModifier value="false"/>
          <isSummary value="false"/>
          <mapping>
            <identity value="rim"/>
            <map value="n/a"/>
          </mapping>
        </element>
        <element id="RegulatedAuthorization.case.extension">
          <path value="RegulatedAuthorization.case.extension"/>
          <short value="Additional content defined by implementations"/>
          <definition
                      value="May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension."/>
          <comment
                   value="There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions.  The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone."/>
          <alias value="extensions"/>
          <alias value="user content"/>
          <min value="0"/>
          <max value="*"/>
          <base>
            <path value="Element.extension"/>
            <min value="0"/>
            <max value="*"/>
          </base>
          <type>
            <code value="Extension"/>
          </type>
          <constraint>
            <key value="ele-1"/>
            <severity value="error"/>
            <human value="All FHIR elements must have a @value or children"/>
            <expression
                        value="hasValue() or (children().count() &gt; id.count())"/>
            <source value="http://hl7.org/fhir/StructureDefinition/Element"/>
          </constraint>
          <constraint>
            <key value="ext-1"/>
            <severity value="error"/>
            <human value="Must have either extensions or value[x], not both"/>
            <expression value="extension.exists() != value.exists()"/>
            <source value="http://hl7.org/fhir/StructureDefinition/Extension"/>
          </constraint>
          <isModifier value="false"/>
          <isSummary value="false"/>
          <mapping>
            <identity value="rim"/>
            <map value="n/a"/>
          </mapping>
        </element>
        <element id="RegulatedAuthorization.case.modifierExtension">
          <path value="RegulatedAuthorization.case.modifierExtension"/>
          <short value="Extensions that cannot be ignored even if unrecognized"/>
          <definition
                      value="May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.

    Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself)."/>
          <comment
                   value="There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions.  The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone."/>
          <requirements
                        value="Modifier extensions allow for extensions that *cannot* be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored.  This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the [definition of modifier extensions](http://hl7.org/fhir/R5/extensibility.html#modifierExtension)."/>
          <alias value="extensions"/>
          <alias value="user content"/>
          <alias value="modifiers"/>
          <min value="0"/>
          <max value="*"/>
          <base>
            <path value="BackboneElement.modifierExtension"/>
            <min value="0"/>
            <max value="*"/>
          </base>
          <type>
            <code value="Extension"/>
          </type>
          <constraint>
            <key value="ele-1"/>
            <severity value="error"/>
            <human value="All FHIR elements must have a @value or children"/>
            <expression
                        value="hasValue() or (children().count() &gt; id.count())"/>
            <source value="http://hl7.org/fhir/StructureDefinition/Element"/>
          </constraint>
          <constraint>
            <key value="ext-1"/>
            <severity value="error"/>
            <human value="Must have either extensions or value[x], not both"/>
            <expression value="extension.exists() != value.exists()"/>
            <source value="http://hl7.org/fhir/StructureDefinition/Extension"/>
          </constraint>
          <isModifier value="true"/>
          <isModifierReason
                            value="Modifier extensions are expected to modify the meaning or interpretation of the element that contains them"/>
          <isSummary value="true"/>
          <mapping>
            <identity value="rim"/>
            <map value="N/A"/>
          </mapping>
        </element>
        <element id="RegulatedAuthorization.case.identifier">
          <path value="RegulatedAuthorization.case.identifier"/>
          <short value="Identifier by which this case can be referenced"/>
          <definition value="Identifier by which this case can be referenced."/>
          <min value="0"/>
          <max value="1"/>
          <base>
            <path value="RegulatedAuthorization.case.identifier"/>
            <min value="0"/>
            <max value="1"/>
          </base>
          <type>
            <code value="Identifier"/>
          </type>
          <constraint>
            <key value="ele-1"/>
            <severity value="error"/>
            <human value="All FHIR elements must have a @value or children"/>
            <expression
                        value="hasValue() or (children().count() &gt; id.count())"/>
            <source value="http://hl7.org/fhir/StructureDefinition/Element"/>
          </constraint>
          <mustSupport value="false"/>
          <isModifier value="false"/>
          <isSummary value="true"/>
          <mapping>
            <identity value="idmp"/>
            <map
                 value="Marketing Authorization Procedure.Procedure Identifier / Number, Marketing Authorization Application.Application Identifier / Number"/>
          </mapping>
        </element>
        <element id="RegulatedAuthorization.case.type">
          <path value="RegulatedAuthorization.case.type"/>
          <short value="The defining type of case"/>
          <definition value="The defining type of case."/>
          <min value="0"/>
          <max value="1"/>
          <base>
            <path value="RegulatedAuthorization.case.type"/>
            <min value="0"/>
            <max value="1"/>
          </base>
          <type>
            <code value="CodeableConcept"/>
          </type>
          <constraint>
            <key value="ele-1"/>
            <severity value="error"/>
            <human value="All FHIR elements must have a @value or children"/>
            <expression
                        value="hasValue() or (children().count() &gt; id.count())"/>
            <source value="http://hl7.org/fhir/StructureDefinition/Element"/>
          </constraint>
          <mustSupport value="false"/>
          <isModifier value="false"/>
          <isSummary value="true"/>
          <binding>
            <extension
                       url="http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName">
              <valueString value="RegulatedAuthorizationCaseType"/>
            </extension>
            <strength value="example"/>
            <description value="The type of a case involved in an application."/>
            <valueSet
                      value="http://hl7.org/fhir/ValueSet/regulated-authorization-case-type|5.0.0"/>
          </binding>
          <mapping>
            <identity value="idmp"/>
            <map
                 value="Marketing Authorization Procedure.Procedure Type, Marketing Authorization Application.Application Type"/>
          </mapping>
        </element>
        <element id="RegulatedAuthorization.case.status">
          <path value="RegulatedAuthorization.case.status"/>
          <short value="The status associated with the case"/>
          <definition value="The status associated with the case."/>
          <min value="0"/>
          <max value="1"/>
          <base>
            <path value="RegulatedAuthorization.case.status"/>
            <min value="0"/>
            <max value="1"/>
          </base>
          <type>
            <code value="CodeableConcept"/>
          </type>
          <constraint>
            <key value="ele-1"/>
            <severity value="error"/>
            <human value="All FHIR elements must have a @value or children"/>
            <expression
                        value="hasValue() or (children().count() &gt; id.count())"/>
            <source value="http://hl7.org/fhir/StructureDefinition/Element"/>
          </constraint>
          <mustSupport value="false"/>
          <isModifier value="false"/>
          <isSummary value="true"/>
          <binding>
            <extension
                       url="http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName">
              <valueString value="PublicationStatus"/>
            </extension>
            <strength value="preferred"/>
            <description value="The lifecycle status of an artifact."/>
            <valueSet
                      value="http://hl7.org/fhir/ValueSet/publication-status|5.0.0"/>
          </binding>
          <mapping>
            <identity value="idmp"/>
            <map value="n/a"/>
          </mapping>
        </element>
        <element id="RegulatedAuthorization.case.date[x]">
          <path value="RegulatedAuthorization.case.date[x]"/>
          <short value="Relevant date for this case"/>
          <definition value="Relevant date for this case."/>
          <min value="0"/>
          <max value="1"/>
          <base>
            <path value="RegulatedAuthorization.case.date[x]"/>
            <min value="0"/>
            <max value="1"/>
          </base>
          <type>
            <code value="Period"/>
          </type>
          <type>
            <code value="dateTime"/>
          </type>
          <constraint>
            <key value="ele-1"/>
            <severity value="error"/>
            <human value="All FHIR elements must have a @value or children"/>
            <expression
                        value="hasValue() or (children().count() &gt; id.count())"/>
            <source value="http://hl7.org/fhir/StructureDefinition/Element"/>
          </constraint>
          <mustSupport value="false"/>
          <isModifier value="false"/>
          <isSummary value="true"/>
          <mapping>
            <identity value="idmp"/>
            <map
                 value="Marketing Authorization Procedure.Procedure Date Start, Marketing Authorization Procedure.Procedure Date End, Marketing Authorization Application.Application Date"/>
          </mapping>
        </element>
        <element id="RegulatedAuthorization.case.application">
          <path value="RegulatedAuthorization.case.application"/>
          <short
                 value="Applications submitted to obtain a regulated authorization. Steps within the longer running case or procedure"/>
          <definition
                      value="A regulatory submission from an organization to a regulator, as part of an assessing case. Multiple applications may occur over time, with more or different information to support or modify the submission or the authorization. The applications can be considered as steps within the longer running case or procedure for this authorization process."/>
          <min value="0"/>
          <max value="*"/>
          <base>
            <path value="RegulatedAuthorization.case.application"/>
            <min value="0"/>
            <max value="*"/>
          </base>
          <contentReference
                            value="http://hl7.org/fhir/StructureDefinition/RegulatedAuthorization#RegulatedAuthorization.case"/>
          <constraint>
            <key value="ele-1"/>
            <severity value="error"/>
            <human value="All FHIR elements must have a @value or children"/>
            <expression
                        value="hasValue() or (children().count() &gt; id.count())"/>
            <source value="http://hl7.org/fhir/StructureDefinition/Element"/>
          </constraint>
          <mustSupport value="false"/>
          <isModifier value="false"/>
          <isSummary value="true"/>
          <mapping>
            <identity value="idmp"/>
            <map
                 value="Marketing Authorization.Marketing Authorization Application"/>
          </mapping>
        </element>
      </snapshot>
      <differential>
        <element id="RegulatedAuthorization">
          <path value="RegulatedAuthorization"/>
        </element>
        <element id="RegulatedAuthorization.subject">
          <path value="RegulatedAuthorization.subject"/>
          <min value="1"/>
          <max value="1"/>
          <type>
            <code value="Reference"/>
            <targetProfile
                           value="http://who-umc.org/idmp/StructureDefinition/MedicinalProductDefinition-who-php-req"/>
          </type>
        </element>
        <element id="RegulatedAuthorization.holder">
          <path value="RegulatedAuthorization.holder"/>
          <min value="1"/>
        </element>
      </differential>
    </StructureDefinition>