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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: scenario4 02 Type II variation validated

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<Task xmlns="http://hl7.org/fhir">
  <id value="scenario4-02-variation-validated"/>
  <meta>
    <versionId value="2"/>
    <lastUpdated value="2027-01-15T14:00:00+01:00"/>
    <profile
             value="http://hl7.org/fhir/uv/apix/StructureDefinition/apix-task"/>
  </meta>
  <language value="en"/>
  <text>
    <status value="generated"/>
    <div xmlns="http://www.w3.org/1999/xhtml"><p><b>Type II variation validated</b></p><table class="grid"><tr><th>Task</th><td>Type II Variation (<code>variation-type-ii</code>)</td></tr><tr><th>Procedure number</th><td>VAR-II-2027-0012</td></tr><tr><th>Version</th><td>2</td></tr><tr><th>Status</th><td>accepted</td></tr><tr><th>Business status</th><td>Validation Successful (<code>validation-successful</code>)</td></tr><tr><th>Requester</th><td>SynthPharma AG</td></tr><tr><th>Owner</th><td>Health Authority – Regulatory Review Division</td></tr><tr><th>Group identifier</th><td>urn:uuid:60ac55b8-8d46-58ff-b1b2-e8015d4960be</td></tr><tr><th>Authored</th><td>2027-01-11T10:00:00+01:00</td></tr><tr><th>Last modified</th><td>2027-01-15T14:00:00+01:00</td></tr></table><p><b>Inputs (from the requester)</b></p><ul><li><a href="DocumentReference-docref-var-cover-letter.html">Variation cover letter</a> <code>cover-letter</code></li><li><a href="DocumentReference-docref-var-application-form.html">Variation application form</a> <code>application-form</code></li><li><a href="DocumentReference-docref-var-change-description.html">Change description and justification</a> <code>change-description</code></li><li><a href="DocumentReference-docref-epi-annotated-v1.html">Annotated ePI v1 (proposal)</a> <code>proposed-labelling</code></li><li><a href="DocumentReference-docref-epi-clean-v1.html">Clean ePI v1 (proposal)</a> <code>epi-bundle</code></li></ul><p><b>Outputs (from the owner)</b></p><ul><li><a href="DocumentReference-docref-var-validation-report.html">Variation validation report</a> <code>validation-report</code></li></ul></div>
  </text>
  <identifier>
    <use value="official"/>
    <type>
      <coding>
        <system value="http://hl7.org/fhir/uv/apix/CodeSystem/apix-demo"/>
        <code value="apixtaskinstance"/>
        <display value="APIX Task Instance ID"/>
      </coding>
    </type>
    <system value="http://example.org/health-authority/task-id"/>
    <value value="urn:uuid:86c83ea7-80e5-5efa-aa1a-4cd36f9a425e"/>
  </identifier>
  <identifier>
    <use value="official"/>
    <type>
      <coding>
        <system value="http://hl7.org/fhir/uv/apix/CodeSystem/apix-demo"/>
        <code value="apixregulatorprocedureno"/>
        <display value="APIX Regulator Procedure Number"/>
      </coding>
    </type>
    <system value="http://example.org/health-authority/procedure-number"/>
    <value value="VAR-II-2027-0012"/>
  </identifier>
  <groupIdentifier>
    <use value="official"/>
    <system value="http://example.org/health-authority/work-flow-group-id"/>
    <value value="urn:uuid:60ac55b8-8d46-58ff-b1b2-e8015d4960be"/>
  </groupIdentifier>
  <status value="accepted"/>
  <businessStatus>
    <coding>
      <system
              value="http://hl7.org/fhir/uv/apix/CodeSystem/apix-business-status"/>
      <code value="validation-successful"/>
      <display value="Validation Successful"/>
    </coding>
  </businessStatus>
  <intent value="proposal"/>
  <priority value="routine"/>
  <code>
    <coding>
      <system value="http://hl7.org/fhir/uv/apix/CodeSystem/apix-task-code"/>
      <code value="variation-type-ii"/>
      <display value="Type II Variation"/>
    </coding>
  </code>
  <executionPeriod>
    <start value="2027-01-15T14:00:00+01:00"/>
  </executionPeriod>
  <authoredOn value="2027-01-11T10:00:00+01:00"/>
  <lastModified value="2027-01-15T14:00:00+01:00"/>
  <requester>🔗 
    <reference value="Organization/org-synthpharma-ag"/>
    <display value="SynthPharma AG"/>
  </requester>
  <owner>🔗 
    <reference value="Organization/org-ema-srm-hmed"/>
    <display value="Health Authority – Regulatory Review Division"/>
  </owner>
  <input>
    <type>
      <coding>
        <system
                value="http://hl7.org/fhir/uv/apix/CodeSystem/apix-task-input-output-type"/>
        <code value="cover-letter"/>
        <display value="Cover Letter"/>
      </coding>
    </type>
    <valueReference>🔗 
      <reference value="DocumentReference/docref-var-cover-letter"/>
      <display value="Variation cover letter"/>
    </valueReference>
  </input>
  <input>
    <type>
      <coding>
        <system
                value="http://hl7.org/fhir/uv/apix/CodeSystem/apix-task-input-output-type"/>
        <code value="application-form"/>
        <display value="Application Form"/>
      </coding>
    </type>
    <valueReference>🔗 
      <reference value="DocumentReference/docref-var-application-form"/>
      <display value="Variation application form"/>
    </valueReference>
  </input>
  <input>
    <type>
      <coding>
        <system
                value="http://hl7.org/fhir/uv/apix/CodeSystem/apix-task-input-output-type"/>
        <code value="change-description"/>
        <display value="Change Description and Justification"/>
      </coding>
    </type>
    <valueReference>🔗 
      <reference value="DocumentReference/docref-var-change-description"/>
      <display value="Change description and justification"/>
    </valueReference>
  </input>
  <input>
    <type>
      <coding>
        <system
                value="http://hl7.org/fhir/uv/apix/CodeSystem/apix-task-input-output-type"/>
        <code value="proposed-labelling"/>
        <display value="Proposed Labelling"/>
      </coding>
    </type>
    <valueReference>🔗 
      <reference value="DocumentReference/docref-epi-annotated-v1"/>
      <display value="Annotated ePI v1 (proposal)"/>
    </valueReference>
  </input>
  <input>
    <type>
      <coding>
        <system
                value="http://hl7.org/fhir/uv/apix/CodeSystem/apix-task-input-output-type"/>
        <code value="epi-bundle"/>
        <display value="ePI Bundle"/>
      </coding>
    </type>
    <valueReference>🔗 
      <reference value="DocumentReference/docref-epi-clean-v1"/>
      <display value="Clean ePI v1 (proposal)"/>
    </valueReference>
  </input>
  <output>
    <type>
      <coding>
        <system
                value="http://hl7.org/fhir/uv/apix/CodeSystem/apix-task-input-output-type"/>
        <code value="validation-report"/>
        <display value="Validation Report"/>
      </coding>
    </type>
    <valueReference>🔗 
      <reference value="DocumentReference/docref-var-validation-report"/>
      <display value="Variation validation report"/>
    </valueReference>
  </output>
</Task>