EMA Write PMS API Implementation Guide - Enrichments
1.0.0 - ci-build

EMA Write PMS API Implementation Guide - Enrichments - Local Development build (v1.0.0) built by the FHIR (HL7® FHIR® Standard) Build Tools. See the Directory of published versions

: 4. Add manufacturing operation - XML Representation

Raw xml | Download


<Bundle xmlns="http://hl7.org/fhir">
  <id value="e4760773-4635-4f49-8f3f-4d085f049199"/>
  <meta>
    <!--  this will exist but is commented out in the IG temporarily  -->
    <!-- profile value="http://hl7.org/fhir/5.0/StructureDefinition/Bundle" / -->
    <profile
             value="http://ema.europa.eu/fhir/definition/esmp/Bundle-variation/0.1.1"/>
    <profile
             value="http://ema.europa.eu/fhir/definition/fhir-adapter/1.0.0.5"/>
  </meta>
  <type value="transaction-response"/>
  <entry>
    <fullUrl
             value="http://ema.europa.eu/example/api/MedicinalProductDefinition/600000709068"/>
    <resource>
      <MedicinalProductDefinition>
        <id value="600000709068"/>
        <meta>
          <versionId value="4"/>
        </meta>
        <text>
          <status value="extensions"/>
          <div xmlns="http://www.w3.org/1999/xhtml"><a name="MedicinalProductDefinition_600000709068"> </a><p class="res-header-id"><b>Generated Narrative: MedicinalProductDefinition 600000709068</b></p><a name="600000709068"> </a><a name="hc600000709068"> </a><a name="600000709068-en-US"> </a><div style="display: inline-block; background-color: #d9e0e7; padding: 6px; margin: 4px; border: 1px solid #8da1b4; border-radius: 5px; line-height: 60%"><p style="margin-bottom: 0px">version: 4</p></div><p><b>Authorised Dose Form</b>: <a href="CodeSystem-200000000004.html#200000000004-100000073683">Pharmaceutical Dose Form 100000073683</a>: Prolonged-release tablet</p><p><b>identifier</b>: <code>http://spor.azure-api.net/pms/api/v2</code>/6055417, <code>http://spor.ema.europa.eu/v1/lists/100000000009/terms/100000075665</code>/PRD417562</p><p><b>domain</b>: <span title="Codes:{http://spor.ema.europa.eu/v1/lists/100000000004 100000000012}">Human use</span></p><p><b>status</b>: <span title="Codes:{http://spor.ema.europa.eu/v1/lists/200000005003 200000005007}">Nullified</span></p><p><b>combinedPharmaceuticalDoseForm</b>: <span title="Codes:{http://spor.ema.europa.eu/v1/lists/200000000006 100000073683}">Prolonged-release tablet</span></p><p><b>additionalMonitoringIndicator</b>: <span title="Codes:{http://ema.europa.eu/fhir/additionalMonitoringIndicator False}">False</span></p><p><b>pediatricUseIndicator</b>: <span title="Codes:{http://ema.europa.eu/fhir/paediatricUseIndicator True}">True</span></p><p><b>classification</b>: <span title="Codes:{http://spor.ema.europa.eu/v1/lists/100000093533 100000098024}">100000098024</span>, <span title="Codes:{http://spor.ema.europa.eu/v1/lists/100000116045 100000116046}">Full application (Article 8(3) of Directive No 2001/83/EC)</span>, <span title="Codes:{http://spor.ema.europa.eu/v1/lists/200000000324 200000003517}">Other</span></p><p><b>attachedDocument</b>: <a href="DocumentReference-13709.html">DocumentReference: status = current</a></p><p><b>masterFile</b>: <a href="DocumentReference-mf1.html">DocumentReference: status = current</a></p><blockquote><p><b>contact</b></p><p><b>type</b>: <span title="Codes:{http://spor.ema.europa.eu/v1/lists/100000154441 200000017719}">Pharmacovigilance Enquiry Information</span></p><p><b>contact</b>: <a href="Organization-phv5633366.html">Organization Dummmy Organization</a></p></blockquote><blockquote><p><b>contact</b></p><p><b>type</b>: <span title="Codes:{http://spor.ema.europa.eu/v1/lists/100000154441 100000155057}">Qualified Person in the EEA for Pharmacovigilance</span></p><p><b>contact</b>: <a href="PractitionerRole-qppv5633367.html">PractitionerRole </a></p></blockquote><blockquote><p><b>name</b></p><p><b>productName</b>: StopCold 5 mg/120 mg comprimidos de liberación prolongada.</p><blockquote><p><b>part</b></p><p><b>part</b>: StopCold</p><p><b>type</b>: <span title="Codes:{http://spor.ema.europa.eu/v1/lists/220000000000 220000000002}">Invented name part</span></p></blockquote><blockquote><p><b>part</b></p><p><b>part</b>: 5 MG/120 MG</p><p><b>type</b>: <span title="Codes:{http://spor.ema.europa.eu/v1/lists/220000000000 220000000004}">Strength part</span></p></blockquote><blockquote><p><b>part</b></p><p><b>part</b>: COMPRIMIDOS DE LIBERACIÓN PROLONGADA</p><p><b>type</b>: <span title="Codes:{http://spor.ema.europa.eu/v1/lists/220000000000 220000000005}">Pharmaceutical dose form part</span></p></blockquote><h3>Usages</h3><table class="grid"><tr><td style="display: none">-</td><td><b>Country</b></td><td><b>Language</b></td></tr><tr><td style="display: none">*</td><td><span title="Codes:{http://spor.ema.europa.eu/v1/lists/100000000002 100000000529}">Spain</span></td><td><span title="Codes:{urn:ietf:bcp:47 es}, {http://spor.ema.europa.eu/v1/lists/100000072057 100000072264}">Spanish</span></td></tr></table></blockquote><blockquote><p><b>operation</b></p><blockquote><p><b>id</b></p>6519944</blockquote><h3>Types</h3><table class="grid"><tr><td style="display: none">-</td><td><b>Reference</b></td></tr><tr><td style="display: none">*</td><td><a href="ActivityDefinition-7371703.html">This is a dummy resource, to make the PMS examples links resolve for QA purposes - but these are not supported in the API currently</a></td></tr></table><p><b>confidentialityIndicator</b>: <span title="Codes:{http://spor.ema.europa.eu/v1/lists/200000004983 200000004984}">Confidential</span></p></blockquote><blockquote><p><b>operation</b></p><h3>Types</h3><table class="grid"><tr><td style="display: none">-</td><td><b>Reference</b></td></tr><tr><td style="display: none">*</td><td><a href="Bundle-e4760773-4635-4f49-8f3f-4d085f049199.html#ActivityDefinition_123456">Bundle: type = transaction-response</a></td></tr></table><p><b>confidentialityIndicator</b>: <span title="Codes:{http://spor.ema.europa.eu/v1/lists/200000004983 200000004985}">Public</span></p></blockquote></div>
        </text>
        <extension
                   url="http://ema.europa.eu/fhir/extension/authorisedDoseForm">
          <valueCoding>
            <extension url="http://ema.europa.eu/fhir/extension/termVersion">
              <valueInteger value="38"/>
            </extension>
            <system value="http://spor.ema.europa.eu/v1/lists/200000000004"/>
            <code value="100000073683"/>
          </valueCoding>
        </extension>
        <identifier>
          <system value="http://spor.azure-api.net/pms/api/v2"/>
          <value value="6055417"/>
        </identifier>
        <identifier>
          <system
                  value="http://spor.ema.europa.eu/v1/lists/100000000009/terms/100000075665"/>
          <value value="PRD417562"/>
        </identifier>
        <domain>
          <coding>
            <extension url="http://ema.europa.eu/fhir/extension/termVersion">
              <valueInteger value="7"/>
            </extension>
            <system value="http://spor.ema.europa.eu/v1/lists/100000000004"/>
            <code value="100000000012"/>
          </coding>
        </domain>
        <status>
          <coding>
            <extension url="http://ema.europa.eu/fhir/extension/termVersion">
              <valueInteger value="3"/>
            </extension>
            <system value="http://spor.ema.europa.eu/v1/lists/200000005003"/>
            <code value="200000005007"/>
          </coding>
        </status>
        <combinedPharmaceuticalDoseForm>
          <coding>
            <extension url="http://ema.europa.eu/fhir/extension/termVersion">
              <valueInteger value="38"/>
            </extension>
            <system value="http://spor.ema.europa.eu/v1/lists/200000000006"/>
            <code value="100000073683"/>
          </coding>
        </combinedPharmaceuticalDoseForm>
        <additionalMonitoringIndicator>
          <coding>
            <system
                    value="http://ema.europa.eu/fhir/additionalMonitoringIndicator"/>
            <code value="False"/>
          </coding>
        </additionalMonitoringIndicator>
        <pediatricUseIndicator>
          <coding>
            <system value="http://ema.europa.eu/fhir/paediatricUseIndicator"/>
            <code value="True"/>
          </coding>
        </pediatricUseIndicator>
        <classification>
          <coding>
            <extension url="http://ema.europa.eu/fhir/extension/termVersion">
              <valueInteger value="3"/>
            </extension>
            <system value="http://spor.ema.europa.eu/v1/lists/100000093533"/>
            <code value="100000098024"/>
          </coding>
        </classification>
        <classification>
          <coding>
            <extension url="http://ema.europa.eu/fhir/extension/termVersion">
              <valueInteger value="8"/>
            </extension>
            <system value="http://spor.ema.europa.eu/v1/lists/100000116045"/>
            <code value="100000116046"/>
          </coding>
        </classification>
        <classification>
          <coding>
            <extension url="http://ema.europa.eu/fhir/extension/termVersion">
              <valueInteger value="2"/>
            </extension>
            <system value="http://spor.ema.europa.eu/v1/lists/200000000324"/>
            <code value="200000003517"/>
          </coding>
        </classification>
        <attachedDocument>🔗 
          <reference value="DocumentReference/13709"/>
        </attachedDocument>
        <masterFile>🔗 
          <reference value="DocumentReference/mf1"/>
        </masterFile>
        <contact>
          <type>
            <coding>
              <extension
                         url="http://ema.europa.eu/fhir/extension/termVersion">
                <valueInteger value="3"/>
              </extension>
              <system
                      value="http://spor.ema.europa.eu/v1/lists/100000154441"/>
              <code value="200000017719"/>
            </coding>
          </type>
          <contact>🔗 
            <reference value="Organization/phv5633366"/>
          </contact>
        </contact>
        <contact>
          <type>
            <coding>
              <extension
                         url="http://ema.europa.eu/fhir/extension/termVersion">
                <valueInteger value="1"/>
              </extension>
              <system
                      value="http://spor.ema.europa.eu/v1/lists/100000154441"/>
              <code value="100000155057"/>
            </coding>
          </type>
          <contact>🔗 
            <reference value="PractitionerRole/qppv5633367"/>
          </contact>
        </contact>
        <name>
          <productName
                       value="StopCold 5 mg/120 mg comprimidos de liberación prolongada."/>
          <part>
            <part value="StopCold"/>
            <type>
              <coding>
                <extension
                           url="http://ema.europa.eu/fhir/extension/termVersion">
                  <valueInteger value="9"/>
                </extension>
                <system
                        value="http://spor.ema.europa.eu/v1/lists/220000000000"/>
                <code value="220000000002"/>
              </coding>
            </type>
          </part>
          <part>
            <part value="5 MG/120 MG"/>
            <type>
              <coding>
                <extension
                           url="http://ema.europa.eu/fhir/extension/termVersion">
                  <valueInteger value="9"/>
                </extension>
                <system
                        value="http://spor.ema.europa.eu/v1/lists/220000000000"/>
                <code value="220000000004"/>
              </coding>
            </type>
          </part>
          <part>
            <part value="COMPRIMIDOS DE LIBERACIÓN PROLONGADA"/>
            <type>
              <coding>
                <extension
                           url="http://ema.europa.eu/fhir/extension/termVersion">
                  <valueInteger value="8"/>
                </extension>
                <system
                        value="http://spor.ema.europa.eu/v1/lists/220000000000"/>
                <code value="220000000005"/>
              </coding>
            </type>
          </part>
          <usage>
            <country>
              <coding>
                <extension
                           url="http://ema.europa.eu/fhir/extension/termVersion">
                  <valueInteger value="19"/>
                </extension>
                <system
                        value="http://spor.ema.europa.eu/v1/lists/100000000002"/>
                <code value="100000000529"/>
              </coding>
            </country>
            <language>
              <!--  language needs an international code, which matches the RMS code  -->
              <coding>
                <system value="urn:ietf:bcp:47"/>
                <code value="es"/>
              </coding>
              <coding>
                <extension
                           url="http://ema.europa.eu/fhir/extension/termVersion">
                  <valueInteger value="2"/>
                </extension>
                <system
                        value="http://spor.ema.europa.eu/v1/lists/100000072057"/>
                <code value="100000072264"/>
              </coding>
            </language>
          </usage>
        </name>
        <operation id="6519944">
          <type>
            <reference>🔗 
              <reference value="ActivityDefinition/7371703"/>
            </reference>
          </type>
          <confidentialityIndicator>
            <coding>
              <system
                      value="http://spor.ema.europa.eu/v1/lists/200000004983"/>
              <code value="200000004984"/>
            </coding>
          </confidentialityIndicator>
        </operation>
        <operation>
          <type>
            <reference>
              <reference value="ActivityDefinition/123456"/>
            </reference>
          </type>
          <confidentialityIndicator>
            <coding>
              <system
                      value="http://spor.ema.europa.eu/v1/lists/200000004983"/>
              <code value="200000004985"/>
            </coding>
          </confidentialityIndicator>
        </operation>
      </MedicinalProductDefinition>
    </resource>
    <response>
      <status value="200"/>
      <location value="MedicinalProductDefinition/600000709068"/>
    </response>
  </entry>
  <entry>
    <fullUrl
             value="http://ema.europa.eu/example/api/PackagedProductDefinition/7868766"/>
    <resource>
      <PackagedProductDefinition>
        <id value="7868766"/>
        <text>
          <status value="generated"/>
          <div xmlns="http://www.w3.org/1999/xhtml"><a name="PackagedProductDefinition_7868766"> </a><p class="res-header-id"><b>Generated Narrative: PackagedProductDefinition 7868766</b></p><a name="7868766"> </a><a name="hc7868766"> </a><a name="7868766-en-US"> </a><p><b>identifier</b>: <code>http://spor.ema.europa.eu/v1/lists/100000000009/terms/100000075665</code>/PRD417562</p><p><b>packageFor</b>: <a href="Bundle-26f73fba-7fce-4a11-ab88-ed5943f40685.html#MedicinalProductDefinition_600000709068">Bundle: type = searchset</a></p><p><b>status</b>: <span title="Codes:{http://spor.ema.europa.eu/v1/lists/200000005003 200000005007}">Nullified</span></p><p><b>containedItemQuantity</b>: 20(unit 200000002152 from http://spor.ema.europa.eu/v1/lists/200000000014)<span style="background: LightGoldenRodYellow"> (Details: Units Of Presentation  code200000002152 = 'Tablet')</span></p><p><b>description</b>: </p><div><p>5MG/120MG PROLONGED RELEASE TABLET</p>
</div></div>
        </text>
        <identifier>
          <system
                  value="http://spor.ema.europa.eu/v1/lists/100000000009/terms/100000075665"/>
          <value value="PRD417562"/>
        </identifier>
        <packageFor>
          <reference value="MedicinalProductDefinition/600000709068"/>
        </packageFor>
        <status>
          <coding>
            <extension url="http://ema.europa.eu/fhir/extension/termVersion">
              <valueInteger value="3"/>
            </extension>
            <system value="http://spor.ema.europa.eu/v1/lists/200000005003"/>
            <code value="200000005007"/>
          </coding>
        </status>
        <containedItemQuantity>
          <value value="20"/>
          <system value="http://spor.ema.europa.eu/v1/lists/200000000014"/>
          <code value="200000002152"/>
        </containedItemQuantity>
        <description value="5MG/120MG PROLONGED RELEASE TABLET">
          <extension url="http://hl7.org/fhir/StructureDefinition/language">
            <!--  language needs an international code, which matches the RMS code  -->
            <valueCode value="es"/>
          </extension>
          <extension url="http://ema.europa.eu/fhir/extension/language">
            <valueCoding>
              <extension
                         url="http://ema.europa.eu/fhir/extension/termVersion">
                <valueInteger value="2"/>
              </extension>
              <system
                      value="http://spor.ema.europa.eu/v1/lists/100000072057"/>
              <code value="100000072264"/>
            </valueCoding>
          </extension>
        </description>
      </PackagedProductDefinition>
    </resource>
    <response>
      <status value="200"/>
      <location value="PackagedProductDefinition/7868766"/>
    </response>
  </entry>
  <entry>
    <fullUrl
             value="http://ema.europa.eu/example/api/ActivityDefinition/123456"/>
    <resource>
      <ActivityDefinition>
        <id value="123456"/>
        <text>
          <status value="extensions"/>
          <div xmlns="http://www.w3.org/1999/xhtml"><a name="ActivityDefinition_123456"> </a>
<div>
    <table class="grid dict">

        

        
        <tr>
            <th scope="row"><b>Id: </b></th>
            <td style="padding-left: 4px;">123456</td>
        </tr>
        

        

        

        
        <tr>
            <th scope="row"><b>Effective Period: </b></th>
            <td style="padding-left: 4px;">2025-03-31..</td>
        </tr>
        

        

        

        

        

        

        

        

        

        

        

        

        

        

        

        

        

        

        
        
        

        
        <tr>
            <th scope="row"><b>Code: </b></th>
            <td style="padding-left: 4px;">
                
                    
                        
                            <p><b>system: </b><span><a href="CodeSystem-100000160406.html">http://spor.ema.europa.eu/v1/lists/100000160406</a></span></p>
                        
                        
                            <p><b>code: </b><span>100000160480</span></p>
                        
                        
                    
                
                
            </td>
        </tr>
        

        

        

        

        

        

        

        

        

        

        

        

        

        
    </table>
</div>
</div>
        </text>
        <status value="active"/>
        <effectivePeriod>
          <start value="2025-03-31"/>
        </effectivePeriod>
        <code>
          <coding>
            <system value="http://spor.ema.europa.eu/v1/lists/100000160406"/>
            <code value="100000160480"/>
          </coding>
        </code>
        <participant>
          <type value="organization"/>
          <typeReference>
            <identifier>
              <system value="http://spor.ema.europa.eu/v1/locations"/>
              <value value="LOC-100068460"/>
            </identifier>
            <display value="Pharma X"/>
          </typeReference>
        </participant>
      </ActivityDefinition>
    </resource>
    <response>
      <status value="200"/>
      <location value="ActivityDefinition/123456"/>
    </response>
  </entry>
  <entry>
    <fullUrl
             value="http://ema.europa.eu/example/api/RegulatedAuthorization/345678"/>
    <resource>
      <RegulatedAuthorization>
        <id value="345678"/>
        <text>
          <status value="generated"/>
          <div xmlns="http://www.w3.org/1999/xhtml"><a name="RegulatedAuthorization_345678"> </a><p class="res-header-id"><b>Generated Narrative: RegulatedAuthorization 345678</b></p><a name="345678"> </a><a name="hc345678"> </a><a name="345678-en-US"> </a><p><b>identifier</b>: <code>http://ema.europa.eu/fhir/manufacturingAuthorizationNumber</code>/12345</p><p><b>subject</b>: <a href="Bundle-e4760773-4635-4f49-8f3f-4d085f049199.html#ActivityDefinition_123456">Bundle: type = transaction-response</a></p><p><b>type</b>: <span title="Codes:{http://spor.ema.europa.eu/v1/lists/220000000060 220000000099}">Manufacturing Authorisation</span></p><p><b>validityPeriod</b>: 2025-03-31 --&gt; (ongoing)</p><p><b>regulator</b>: Finnish Medicines Agency (Identifier: <code>http://spor.ema.europa.eu/v1/locations</code>/LOC-100000015)</p></div>
        </text>
        <identifier>
          <system
                  value="http://ema.europa.eu/fhir/manufacturingAuthorizationNumber"/>
          <value value="12345"/>
        </identifier>
        <subject>
          <reference value="ActivityDefinition/123456"/>
        </subject>
        <type>
          <coding>
            <system value="http://spor.ema.europa.eu/v1/lists/220000000060"/>
            <code value="220000000099"/>
          </coding>
        </type>
        <validityPeriod>
          <start value="2025-03-31"/>
        </validityPeriod>
        <regulator>
          <identifier>
            <system value="http://spor.ema.europa.eu/v1/locations"/>
            <value value="LOC-100000015"/>
          </identifier>
          <display value="Finnish Medicines Agency"/>
        </regulator>
      </RegulatedAuthorization>
    </resource>
    <response>
      <status value="200"/>
      <location value="RegulatedAuthorization/345678"/>
    </response>
  </entry>
  <entry>
    <fullUrl
             value="http://ema.europa.eu/example/api/ActivityDefinition/7371703"/>
    <resource>
      <ActivityDefinition>
        <id value="7371703"/>
        <text>
          <status value="extensions"/>
          <div xmlns="http://www.w3.org/1999/xhtml"><a name="ActivityDefinition_7371703"> </a>
<div>
    <table class="grid dict">

        

        
        <tr>
            <th scope="row"><b>Id: </b></th>
            <td style="padding-left: 4px;">7371703</td>
        </tr>
        

        

        

        
        <tr>
            <th scope="row"><b>Effective Period: </b></th>
            <td style="padding-left: 4px;">2024-12-01..</td>
        </tr>
        

        

        

        

        

        

        

        

        

        

        

        

        

        

        

        

        

        

        
        
        

        
        <tr>
            <th scope="row"><b>Code: </b></th>
            <td style="padding-left: 4px;">
                
                    
                        
                            <p><b>system: </b><span><a href="CodeSystem-100000160406.html">http://spor.ema.europa.eu/v1/lists/100000160406</a></span></p>
                        
                        
                            <p><b>code: </b><span>100000160478</span></p>
                        
                        
                    
                
                
            </td>
        </tr>
        

        

        

        

        

        

        

        

        

        

        

        

        

        
    </table>
</div>
</div>
        </text>
        <status value="active"/>
        <effectivePeriod>
          <start value="2024-12-01"/>
        </effectivePeriod>
        <code>
          <coding>
            <system value="http://spor.ema.europa.eu/v1/lists/100000160406"/>
            <code value="100000160478"/>
          </coding>
        </code>
        <participant>
          <type value="organization"/>
          <typeReference>
            <identifier>
              <system value="http://spor.ema.europa.eu/v1/locations"/>
              <value value="LOC-100068457"/>
            </identifier>
            <display value="1 4 U Pharma GmbH"/>
          </typeReference>
        </participant>
      </ActivityDefinition>
    </resource>
    <response>
      <status value="200"/>
      <location value="ActivityDefinition/7371703"/>
    </response>
  </entry>
  <entry>
    <fullUrl
             value="http://ema.europa.eu/example/api/RegulatedAuthorization/6756012"/>
    <resource>
      <RegulatedAuthorization>
        <id value="6756012"/>
        <text>
          <status value="generated"/>
          <div xmlns="http://www.w3.org/1999/xhtml"><a name="RegulatedAuthorization_6756012"> </a><p class="res-header-id"><b>Generated Narrative: RegulatedAuthorization 6756012</b></p><a name="6756012"> </a><a name="hc6756012"> </a><a name="6756012-en-US"> </a><p><b>identifier</b>: <code>http://ema.europa.eu/fhir/MarketingAuthorizationNumber</code>/62.102</p><p><b>subject</b>: <a href="Bundle-26f73fba-7fce-4a11-ab88-ed5943f40685.html#MedicinalProductDefinition_600000709068">Bundle: type = searchset</a></p><p><b>type</b>: <span title="Codes:{http://spor.ema.europa.eu/v1/lists/220000000060 220000000061}">Marketing Authorisation</span></p><p><b>region</b>: <span title="Codes:{http://spor.ema.europa.eu/v1/lists/100000000002 100000000529}">Spain</span></p><p><b>status</b>: <span title="Codes:{http://spor.ema.europa.eu/v1/lists/100000072049 200000032263}">Not valid - Superseded by marketing authorisation transfer</span></p><p><b>statusDate</b>: 2025-02-18 00:00:00+0000</p><p><b>holder</b>: Kern Pharma S.L. (Identifier: <code>http://spor.ema.europa.eu/v1/locations</code>/LOC-100002956)</p><p><b>regulator</b>: ES (Identifier: <code>http://spor.ema.europa.eu/v1/locations</code>/ES)</p><h3>Cases</h3><table class="grid"><tr><td style="display: none">-</td><td><b>Type</b></td></tr><tr><td style="display: none">*</td><td><span title="Codes:{http://spor.ema.europa.eu/v1/lists/100000154442 100000155062}">National Procedure</span></td></tr></table></div>
        </text>
        <identifier>
          <system
                  value="http://ema.europa.eu/fhir/MarketingAuthorizationNumber"/>
          <value value="62.102"/>
        </identifier>
        <subject>
          <reference value="MedicinalProductDefinition/600000709068"/>
        </subject>
        <type>
          <coding>
            <extension url="http://ema.europa.eu/fhir/extension/termVersion">
              <valueInteger value="1"/>
            </extension>
            <system value="http://spor.ema.europa.eu/v1/lists/220000000060"/>
            <code value="220000000061"/>
          </coding>
        </type>
        <region>
          <coding>
            <extension url="http://ema.europa.eu/fhir/extension/termVersion">
              <valueInteger value="22"/>
            </extension>
            <system value="http://spor.ema.europa.eu/v1/lists/100000000002"/>
            <code value="100000000529"/>
          </coding>
        </region>
        <status>
          <coding>
            <extension url="http://ema.europa.eu/fhir/extension/termVersion">
              <valueInteger value="3"/>
            </extension>
            <system value="http://spor.ema.europa.eu/v1/lists/100000072049"/>
            <code value="200000032263"/>
          </coding>
        </status>
        <statusDate value="2025-02-18T00:00:00Z"/>
        <holder>
          <identifier>
            <system value="http://spor.ema.europa.eu/v1/locations"/>
            <value value="LOC-100002956"/>
          </identifier>
          <display value="Kern Pharma S.L."/>
        </holder>
        <regulator>
          <identifier>
            <system value="http://spor.ema.europa.eu/v1/locations"/>
            <value value="ES"/>
          </identifier>
          <display value="ES"/>
        </regulator>
        <case>
          <type>
            <coding>
              <extension
                         url="http://ema.europa.eu/fhir/extension/termVersion">
                <valueInteger value="14"/>
              </extension>
              <system
                      value="http://spor.ema.europa.eu/v1/lists/100000154442"/>
              <code value="100000155062"/>
            </coding>
          </type>
        </case>
      </RegulatedAuthorization>
    </resource>
    <response>
      <status value="200"/>
      <location value="RegulatedAuthorization/6756012"/>
    </response>
  </entry>
  <entry>
    <fullUrl
             value="http://ema.europa.eu/example/api/RegulatedAuthorization/6362767"/>
    <resource>
      <RegulatedAuthorization>
        <id value="6362767"/>
        <text>
          <status value="generated"/>
          <div xmlns="http://www.w3.org/1999/xhtml"><a name="RegulatedAuthorization_6362767"> </a><p class="res-header-id"><b>Generated Narrative: RegulatedAuthorization 6362767</b></p><a name="6362767"> </a><a name="hc6362767"> </a><a name="6362767-en-US"> </a><p><b>identifier</b>: <code>http://ema.europa.eu/fhir/MarketingAuthorizationNumber</code>/62.102</p><p><b>subject</b>: <a href="Bundle-26f73fba-7fce-4a11-ab88-ed5943f40685.html#PackagedProductDefinition_7868766">Bundle: type = searchset</a></p><p><b>type</b>: <span title="Codes:{http://spor.ema.europa.eu/v1/lists/220000000060 220000000061}">Marketing Authorisation</span></p><p><b>region</b>: <span title="Codes:{http://spor.ema.europa.eu/v1/lists/100000000002 100000000529}">Spain</span></p><p><b>status</b>: <span title="Codes:{http://spor.ema.europa.eu/v1/lists/100000072049 200000032263}">Not valid - Superseded by marketing authorisation transfer</span></p><p><b>statusDate</b>: 2025-02-18 00:00:00+0000</p></div>
        </text>
        <identifier>
          <system
                  value="http://ema.europa.eu/fhir/MarketingAuthorizationNumber"/>
          <value value="62.102"/>
        </identifier>
        <subject>
          <reference value="PackagedProductDefinition/7868766"/>
        </subject>
        <type>
          <coding>
            <extension url="http://ema.europa.eu/fhir/extension/termVersion">
              <valueInteger value="1"/>
            </extension>
            <system value="http://spor.ema.europa.eu/v1/lists/220000000060"/>
            <code value="220000000061"/>
          </coding>
        </type>
        <region>
          <coding>
            <extension url="http://ema.europa.eu/fhir/extension/termVersion">
              <valueInteger value="22"/>
            </extension>
            <system value="http://spor.ema.europa.eu/v1/lists/100000000002"/>
            <code value="100000000529"/>
          </coding>
        </region>
        <status>
          <coding>
            <extension url="http://ema.europa.eu/fhir/extension/termVersion">
              <valueInteger value="3"/>
            </extension>
            <system value="http://spor.ema.europa.eu/v1/lists/100000072049"/>
            <code value="200000032263"/>
          </coding>
        </status>
        <statusDate value="2025-02-18T00:00:00Z"/>
      </RegulatedAuthorization>
    </resource>
    <response>
      <status value="200"/>
      <location value="RegulatedAuthorization/6362767"/>
    </response>
  </entry>
  <entry>
    <fullUrl
             value="http://ema.europa.eu/example/api/RegulatedAuthorization/6094279"/>
    <resource>
      <RegulatedAuthorization>
        <id value="6094279"/>
        <text>
          <status value="generated"/>
          <div xmlns="http://www.w3.org/1999/xhtml"><a name="RegulatedAuthorization_6094279"> </a><p class="res-header-id"><b>Generated Narrative: RegulatedAuthorization 6094279</b></p><a name="6094279"> </a><a name="hc6094279"> </a><a name="6094279-en-US"> </a><p><b>subject</b>: <a href="ActivityDefinition-7371703.html">This is a dummy resource, to make the PMS examples links resolve for QA purposes - but these are not supported in the API currently</a></p><p><b>type</b>: <span title="Codes:{http://spor.ema.europa.eu/v1/lists/220000000060 220000000099}">Manufacturing Authorisation</span></p><p><b>validityPeriod</b>: 2024-12-01 --&gt; (ongoing)</p><p><b>regulator</b>: Finnish Medicines Agency (Identifier: <code>http://spor.ema.europa.eu/v1/locations</code>/LOC-100000015)</p></div>
        </text>
        <subject>🔗 
          <reference value="ActivityDefinition/7371703"/>
        </subject>
        <type>
          <coding>
            <system value="http://spor.ema.europa.eu/v1/lists/220000000060"/>
            <code value="220000000099"/>
          </coding>
        </type>
        <validityPeriod>
          <start value="2024-12-01"/>
        </validityPeriod>
        <regulator>
          <identifier>
            <system value="http://spor.ema.europa.eu/v1/locations"/>
            <value value="LOC-100000015"/>
          </identifier>
          <display value="Finnish Medicines Agency"/>
        </regulator>
      </RegulatedAuthorization>
    </resource>
    <response>
      <status value="200"/>
      <location value="RegulatedAuthorization/6094279"/>
    </response>
  </entry>
</Bundle>