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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: scenario3 03 request for information issued

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<Task xmlns="http://hl7.org/fhir">
  <id value="scenario3-03-cta-rfi"/>
  <meta>
    <versionId value="1"/>
    <lastUpdated value="2026-10-01T11:00:00+02:00"/>
    <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>Request for information issued</b></p><table class="grid"><tr><th>Task</th><td>List of Questions / Information Request (<code>information-request</code>)</td></tr><tr><th>Procedure number</th><td>CT-2026-000789</td></tr><tr><th>Version</th><td>1</td></tr><tr><th>Status</th><td>requested</td></tr><tr><th>Business status</th><td>Request for Information Issued (<code>request-for-information-issued</code>)</td></tr><tr><th>Requester</th><td>Health Authority – Regulatory Review Division</td></tr><tr><th>Owner</th><td>SynthPharma AG</td></tr><tr><th>Group identifier</th><td>urn:uuid:0a57b9f1-fc39-5bae-a93a-c86bd94484a5</td></tr><tr><th>Authored</th><td>2026-10-01T11:00:00+02:00</td></tr><tr><th>Last modified</th><td>2026-10-01T11:00:00+02:00</td></tr><tr><th>Based on</th><td><a href="Task-scenario3-01-cta-submission.html">scenario3-01-cta-submission</a></td></tr><tr><th>Response due</th><td>2026-10-15T23:59:59+02:00</td></tr></table><p><b>Inputs (from the requester)</b></p><ul><li><a href="DocumentReference-docref-cta-rfi.html">Request for information</a> <code>request-for-information</code></li></ul><p><b>Outputs (from the owner)</b></p><p>None</p></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:d1bba8de-3301-5250-b6aa-6dbc38489f29"/>
  </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/clinical-trial-number"/>
    <value value="CT-2026-000789"/>
  </identifier>
  <basedOn>🔗 
    <reference value="Task/scenario3-01-cta-submission"/>
  </basedOn>
  <groupIdentifier>
    <use value="official"/>
    <system value="http://example.org/health-authority/work-flow-group-id"/>
    <value value="urn:uuid:0a57b9f1-fc39-5bae-a93a-c86bd94484a5"/>
  </groupIdentifier>
  <status value="requested"/>
  <businessStatus>
    <coding>
      <system
              value="http://hl7.org/fhir/uv/apix/CodeSystem/apix-business-status"/>
      <code value="request-for-information-issued"/>
      <display value="Request for Information Issued"/>
    </coding>
  </businessStatus>
  <intent value="proposal"/>
  <priority value="routine"/>
  <code>
    <coding>
      <system value="http://hl7.org/fhir/uv/apix/CodeSystem/apix-task-code"/>
      <code value="information-request"/>
      <display value="List of Questions / Information Request"/>
    </coding>
  </code>
  <requestedPeriod>
    <start value="2026-10-01T11:00:00+02:00"/>
    <end value="2026-10-15T23:59:59+02:00"/>
  </requestedPeriod>
  <authoredOn value="2026-10-01T11:00:00+02:00"/>
  <lastModified value="2026-10-01T11:00:00+02:00"/>
  <requester>🔗 
    <reference value="Organization/org-ema-srm-hmed"/>
    <display value="Health Authority – Regulatory Review Division"/>
  </requester>
  <owner>🔗 
    <reference value="Organization/org-synthpharma-ag"/>
    <display value="SynthPharma AG"/>
  </owner>
  <input>
    <type>
      <coding>
        <system
                value="http://hl7.org/fhir/uv/apix/CodeSystem/apix-task-input-output-type"/>
        <code value="request-for-information"/>
        <display value="Request for Information"/>
      </coding>
    </type>
    <valueReference>🔗 
      <reference value="DocumentReference/docref-cta-rfi"/>
      <display value="Request for information"/>
    </valueReference>
  </input>
</Task>