Regulatory Workflows and Interactions - pharma, published by HL7 International / Biomedical Research and Regulation. This guide is not an authorized publication; it is the continuous build for version 0.1.0 built by the FHIR (HL7® FHIR® Standard) CI Build. This version is based on the current content of https://github.com/HL7/APIX---API-Exchange-for-Medicinal-Products/ and changes regularly. See the Directory of published versions

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: Annotated ePI v2 (regulator comments, round 1)

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<DocumentReference xmlns="http://hl7.org/fhir">
  <id value="docref-epi-annotated-v2"/>
  <meta>
    <profile
             value="http://hl7.org/fhir/uv/apix/StructureDefinition/apix-documentreference"/>
  </meta>
  <language value="en"/>
  <text>
    <status value="generated"/>
    <div xmlns="http://www.w3.org/1999/xhtml"><p class="res-header-id"><b>Generated Narrative: DocumentReference docref-epi-annotated-v2</b></p><a name="docref-epi-annotated-v2"> </a><a name="hcdocref-epi-annotated-v2"> </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"/><p style="margin-bottom: 0px">Profile: <a href="StructureDefinition-apix-documentreference.html">APIX Regulatory DocumentReference</a></p></div><p><b>identifier</b>: Document Set Identifier/urn:uuid:700f0cc4-7500-5394-8c7f-cc1a47f697fc, Document Version Number Identifier/urn:uuid:888a24fe-5349-56ad-bcd4-d5181ab7dc71</p><p><b>version</b>: 2</p><p><b>status</b>: Current</p><p><b>docStatus</b>: Final</p><p><b>type</b>: <span title="Codes:{http://hl7.org/fhir/uv/apix/CodeSystem/apix-task-input-output-type labelling-comments}">Labelling Comments</span></p><p><b>date</b>: 2027-02-22 10:00:00+0100</p><p><b>author</b>: <a href="Organization-org-ema-srm-hmed.html">Health Authority – Regulatory Review Division</a></p><h3>RelatesTos</h3><table class="grid"><tr><td style="display: none">-</td><td><b>Code</b></td><td><b>Target</b></td></tr><tr><td style="display: none">*</td><td><span title="Codes:{http://hl7.org/fhir/document-relationship-type replaces}">Replaces</span></td><td><a href="DocumentReference-docref-epi-annotated-v1.html">DocumentReference: identifier = Document Set Identifier: urn:uuid:700f0cc4-7500-5394-8c7f-cc1a47f697fc,Document Version Number Identifier: urn:uuid:8ee1964d-f23e-5dc2-8f64-7fbbc2e94416; version = 1; status = current; docStatus = final; type = Proposed Labelling; date = 2027-01-11 10:00:00+0100; description = Proposed product information as annotated ePI, version 1: adds nausea (uncommon) to SmPC 4.8 and leaflet section 4.</a></td></tr></table><p><b>description</b>: </p><div><p>Regulator's tracked changes on v1: nausea frequency raised to common; intake with food required (SmPC 4.2, leaflet section 3).</p>
</div><blockquote><p><b>content</b></p><h3>Attachments</h3><table class="grid"><tr><td style="display: none">-</td><td><b>ContentType</b></td><td><b>Url</b></td><td><b>Size</b></td><td><b>Hash</b></td><td><b>Title</b></td><td><b>Creation</b></td></tr><tr><td style="display: none">*</td><td>application/fhir+xml</td><td><a href="Binary-binary-epi-annotated-v2.html">Binary: application/fhir+xml (6404 bytes base64)</a></td><td>4802</td><td><code>8jcYmg+KSvZyKEK5Kw4HBKCUVRQ=</code></td><td>epi-annotated-v2.xml</td><td>2027-02-22 10:00:00+0100</td></tr></table></blockquote></div>
  </text>
  <identifier>
    <type>
      <coding>
        <system value="http://hl7.org/fhir/uv/apix/CodeSystem/apix-demo"/>
        <code value="docsetid"/>
        <display value="Document Set Identifier"/>
      </coding>
    </type>
    <system value="http://example.org/synthpharma/document-set-id"/>
    <value value="urn:uuid:700f0cc4-7500-5394-8c7f-cc1a47f697fc"/>
  </identifier>
  <identifier>
    <type>
      <coding>
        <system value="http://hl7.org/fhir/uv/apix/CodeSystem/apix-demo"/>
        <code value="docverid"/>
        <display value="Document Version Number Identifier"/>
      </coding>
    </type>
    <system value="http://example.org/health-authority/document-version-id"/>
    <value value="urn:uuid:888a24fe-5349-56ad-bcd4-d5181ab7dc71"/>
  </identifier>
  <version value="2"/>
  <status value="current"/>
  <docStatus value="final"/>
  <type>
    <coding>
      <system
              value="http://hl7.org/fhir/uv/apix/CodeSystem/apix-task-input-output-type"/>
      <code value="labelling-comments"/>
      <display value="Labelling Comments"/>
    </coding>
  </type>
  <date value="2027-02-22T10:00:00+01:00"/>
  <author>🔗 
    <reference value="Organization/org-ema-srm-hmed"/>
    <display value="Health Authority – Regulatory Review Division"/>
  </author>
  <relatesTo>
    <code>
      <coding>
        <system value="http://hl7.org/fhir/document-relationship-type"/>
        <code value="replaces"/>
        <display value="Replaces"/>
      </coding>
    </code>
    <target>🔗 
      <reference value="DocumentReference/docref-epi-annotated-v1"/>
    </target>
  </relatesTo>
  <description
               value="Regulator's tracked changes on v1: nausea frequency raised to common; intake with food required (SmPC 4.2, leaflet section 3)."/>
  <content>
    <attachment>
      <contentType value="application/fhir+xml"/>
      <url value="Binary/binary-epi-annotated-v2"/>
      <size value="4802"/>
      <hash value="8jcYmg+KSvZyKEK5Kw4HBKCUVRQ="/>
      <title value="epi-annotated-v2.xml"/>
      <creation value="2027-02-22T10:00:00+01:00"/>
    </attachment>
  </content>
</DocumentReference>