European Medicines Regulatory Network (EMRN) Electronic Product Information (ePI) Implementation Guide
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European Medicines Regulatory Network (EMRN) Electronic Product Information (ePI) Implementation Guide - Local Development build (v0.4.0) built by the FHIR (HL7® FHIR® Standard) Build Tools. See the Directory of published versions

: ePI Regulated Authorization example 1 - XML Representation

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<RegulatedAuthorization xmlns="http://hl7.org/fhir">
  <id value="06a1cd7d-ced4-4181-9d8f-fd2ed7393c57"/>
  <meta>
    <profile
             value="http://ema.europa.eu/fhir/StructureDefinition/EUEpiRegulatedAuthorization"/>
  </meta>
  <text>
    <status value="generated"/>
    <div xmlns="http://www.w3.org/1999/xhtml"><p class="res-header-id"><b>Generated Narrative: RegulatedAuthorization 06a1cd7d-ced4-4181-9d8f-fd2ed7393c57</b></p><a name="06a1cd7d-ced4-4181-9d8f-fd2ed7393c57"> </a><a name="hc06a1cd7d-ced4-4181-9d8f-fd2ed7393c57"> </a><a name="06a1cd7d-ced4-4181-9d8f-fd2ed7393c57-en-US"> </a><p><b>identifier</b>: <code>http://ema.europa.eu/fhir/epiId</code>/EPI/23/1024</p><p><b>subject</b>: Reference to EPI/23/1024 (Identifier: <code>http://ema.europa.eu/fhir/epiId</code>/EPI/23/1024)</p><p><b>type</b>: <span title="Codes:{https://spor.ema.europa.eu/v1/lists/220000000060 220000000061}">electronic Product Information (ePI) Authorisation</span></p><p><b>description</b>: </p><div><p>This is the authorization for EPI/23/1024</p>
</div><p><b>region</b>: <span title="Codes:{http://ema.europa.eu/fhir/CodeSystem/region EU}">EU</span></p><p><b>status</b>: <span title="Codes:{http://hl7.org/fhir/publication-status active}">Active</span></p><p><b>statusDate</b>: 2024-01-31</p><p><b>validityPeriod</b>: 2024-01-31 --&gt; (ongoing)</p><p><b>holder</b>: UAT ORG (ORG-200036100) (Identifier: <code>https://spor.ema.europa.eu/v1/organisations</code>/ORG-200036100)</p><p><b>regulator</b>: European Medicines Agency (Identifier: <code>https://spor.ema.europa.eu/v1/organisations</code>/ORG-100013412)</p><h3>Cases</h3><table class="grid"><tr><td style="display: none">-</td><td><b>Identifier</b></td><td><b>Type</b></td></tr><tr><td style="display: none">*</td><td><code>http://ema.europa.eu/fhir/procedureIdentifierNumber</code>/001</td><td><span title="Codes:{https://spor.ema.europa.eu/v1/lists/100000154442 100000155059}">CAP</span></td></tr></table></div>
  </text>
  <identifier>
    <system value="http://ema.europa.eu/fhir/epiId"/>
    <value value="EPI/23/1024"/>
  </identifier>
  <subject>
    <identifier>
      <system value="http://ema.europa.eu/fhir/epiId"/>
      <value value="EPI/23/1024"/>
    </identifier>
    <display value="Reference to EPI/23/1024"/>
  </subject>
  <type>
    <coding>
      <system value="https://spor.ema.europa.eu/v1/lists/220000000060"/>
      <code value="220000000061"/>
      <display value="electronic Product Information (ePI) Authorisation"/>
    </coding>
  </type>
  <description value="This is the authorization for EPI/23/1024"/>
  <region>
    <coding>
      <system value="http://ema.europa.eu/fhir/CodeSystem/region"/>
      <code value="EU"/>
    </coding>
  </region>
  <status>
    <coding>
      <system value="http://hl7.org/fhir/publication-status"/>
      <code value="active"/>
      <display value="Active"/>
    </coding>
  </status>
  <statusDate value="2024-01-31"/>
  <validityPeriod>
    <start value="2024-01-31"/>
  </validityPeriod>
  <holder>
    <identifier>
      <system value="https://spor.ema.europa.eu/v1/organisations"/>
      <value value="ORG-200036100"/>
    </identifier>
    <display value="UAT ORG (ORG-200036100)"/>
  </holder>
  <regulator>
    <identifier>
      <system value="https://spor.ema.europa.eu/v1/organisations"/>
      <value value="ORG-100013412"/>
    </identifier>
    <display value="European Medicines Agency"/>
  </regulator>
  <case>
    <identifier>
      <system value="http://ema.europa.eu/fhir/procedureIdentifierNumber"/>
      <value value="001"/>
    </identifier>
    <type>
      <coding>
        <system value="https://spor.ema.europa.eu/v1/lists/100000154442"/>
        <code value="100000155059"/>
        <display value="CAP"/>
      </coding>
    </type>
  </case>
</RegulatedAuthorization>