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

• Narrative Content
• XML
• JSON
• TTL

: Authorisation decision

Raw xml | Download

<DocumentReference xmlns="http://hl7.org/fhir">
  <id value="docref-cta-decision"/>
  <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-cta-decision</b></p><a name="docref-cta-decision"> </a><a name="hcdocref-cta-decision"> </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:db0d54fe-c6ea-58be-9135-94aff57fab27, Document Version Number Identifier/urn:uuid:69682214-86ca-593d-8af7-6e7910c002cc</p><p><b>version</b>: 1</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 authorisation-decision}">Authorisation Decision</span></p><p><b>date</b>: 2026-11-03 09:00:00+0100</p><p><b>author</b>: <a href="Organization-org-ema-srm-hmed.html">Health Authority – Regulatory Review Division</a></p><p><b>description</b>: </p><div><p>Decision authorising clinical trial CT-2026-000789.</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/pdf</td><td><a href="Binary-binary-cta-decision.html">Binary: application/pdf (3080 bytes base64)</a></td><td>2309</td><td><code>gHyCDynJrvg4VoxjUbMFMfhNLBs=</code></td><td>cta-authorisation-decision.pdf</td><td>2026-11-03 09:00:00+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/health-authority/document-set-id"/>
    <value value="urn:uuid:db0d54fe-c6ea-58be-9135-94aff57fab27"/>
  </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:69682214-86ca-593d-8af7-6e7910c002cc"/>
  </identifier>
  <version value="1"/>
  <status value="current"/>
  <docStatus value="final"/>
  <type>
    <coding>
      <system
              value="http://hl7.org/fhir/uv/apix/CodeSystem/apix-task-input-output-type"/>
      <code value="authorisation-decision"/>
      <display value="Authorisation Decision"/>
    </coding>
  </type>
  <date value="2026-11-03T09:00:00+01:00"/>
  <author>🔗 
    <reference value="Organization/org-ema-srm-hmed"/>
    <display value="Health Authority – Regulatory Review Division"/>
  </author>
  <description value="Decision authorising clinical trial CT-2026-000789."/>
  <content>
    <attachment>
      <contentType value="application/pdf"/>
      <url value="Binary/binary-cta-decision"/>
      <size value="2309"/>
      <hash value="gHyCDynJrvg4VoxjUbMFMfhNLBs="/>
      <title value="cta-authorisation-decision.pdf"/>
      <creation value="2026-11-03T09:00:00+01:00"/>
    </attachment>
  </content>
</DocumentReference>