Response to Regulatory Questions (RTQ), published by HL7 International. 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/rtq-ig/ and changes regularly. See the Directory of published versions

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• XML
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• TTL

: QuestionnaireResponse - XML Representation

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<QuestionnaireResponse xmlns="http://hl7.org/fhir">
  <id value="QuestionnaireResponse"/>
  <meta>
    <versionId value="1"/>
    <lastUpdated value="2025-11-20T22:30:00Z"/>
    <profile
             value="http://hl7.org/fhir/uv/rtq/StructureDefinition/rtq-questionnaireresponse"/>
  </meta>
  <identifier>
    <system value="http://hl7.org/fhir/uv/brr/identifier/qa-request"/>
    <value value="ID001"/>
  </identifier>
  <identifier>
    <system value="https://ema.europa.eu/procedure-number"/>
    <value value="EMEA/H/C/005432/II/0023"/>
  </identifier>
  <text>
    <status value="generated"/>
    <div xmlns="http://www.w3.org/1999/xhtml">
      <p>Dear Assessment Team,</p>
      <p>Please find below the structured responses to the List of Questions issued on 2025-05-20
        for the Type II variation (EMEA/H/C/005432/II/0023) concerning ExampleDrug 10 mg Tablets.</p>
      <p>Yours sincerely,<br/>Dr. John Doe<br/>Head of Regulatory Affairs<br/>SynthPharma AG</p>
    </div>
  </text>
  <questionnaire value="questionnaire_ID001"/>
  <status value="completed"/>
  <subject>
    <reference
               value="MedicinalProductDefinition/MedicinalProduct-ExampleDrug"/>
    <display value="ExampleDrug 10 mg Tablets"/>
  </subject>
  <!--  Author = Regulatory Authority (EMA) – full inline Organization  -->
  <author>
    <type value="Organization"/>
    <identifier>
      <system value="https://ema.europa.eu/organization-id"/>
      <value value="EMA"/>
    </identifier>
  </author>
  <!--  Source = Marketing Authorisation Holder (SynthPharma AG) – full inline Organization  -->
  <source>
    <type value="Organization"/>
    <identifier>
      <system value="https://www.zefix.ch/en/SwissCompanyRegistry/UID"/>
      <value value="CHE-123.456.789"/>
    </identifier>
  </source>
  <authored value="2025-06-25T14:00:00+02:00"/>
  <item>
    <linkId value="1"/>
    <extension url="http://hl7.org/fhir/StructureDefinition/rendering-xhtml">
      <valueXhtml/>
    </extension>
    <answer>
      <extension
                 url="http://hl7.org/fhir/StructureDefinition/rendering-xhtml">
        <valueXhtml/>
      </extension>
    </answer>
  </item>
  <item>
    <linkId value="2"/>
    <extension url="http://hl7.org/fhir/StructureDefinition/rendering-xhtml">
      <valueXhtml/>
    </extension>
    <answer>
      <extension
                 url="http://hl7.org/fhir/StructureDefinition/rendering-xhtml">
        <valueXhtml/>
      </extension>
    </answer>
  </item>
  <item>
    <linkId value="3"/>
    <extension url="http://hl7.org/fhir/StructureDefinition/rendering-xhtml">
      <valueXhtml/>
    </extension>
    <answer>
      <extension
                 url="http://hl7.org/fhir/StructureDefinition/rendering-xhtml">
        <valueXhtml/>
      </extension>
    </answer>
  </item>
  <item>
    <linkId value="4"/>
    <extension url="http://hl7.org/fhir/StructureDefinition/rendering-xhtml">
      <valueXhtml/>
    </extension>
    <answer>
      <extension
                 url="http://hl7.org/fhir/StructureDefinition/rendering-xhtml">
        <valueXhtml/>
      </extension>
    </answer>
  </item>
  <item>
    <linkId value="5"/>
    <extension url="http://hl7.org/fhir/StructureDefinition/rendering-xhtml">
      <valueXhtml/>
    </extension>
    <answer>
      <extension
                 url="http://hl7.org/fhir/StructureDefinition/rendering-xhtml">
        <valueXhtml/>
      </extension>
    </answer>
  </item>
  <item>
    <linkId value="6"/>
    <extension url="http://hl7.org/fhir/StructureDefinition/rendering-xhtml">
      <valueXhtml/>
    </extension>
    <answer>
      <extension
                 url="http://hl7.org/fhir/StructureDefinition/rendering-xhtml">
        <valueXhtml/>
      </extension>
    </answer>
  </item>
  <item>
    <linkId value="7"/>
    <extension url="http://hl7.org/fhir/StructureDefinition/rendering-xhtml">
      <valueXhtml/>
    </extension>
    <answer>
      <extension
                 url="http://hl7.org/fhir/StructureDefinition/rendering-xhtml">
        <valueXhtml/>
      </extension>
    </answer>
  </item>
  <item>
    <linkId value="8"/>
    <extension url="http://hl7.org/fhir/StructureDefinition/rendering-xhtml">
      <valueXhtml/>
    </extension>
    <answer>
      <extension
                 url="http://hl7.org/fhir/StructureDefinition/rendering-xhtml">
        <valueXhtml/>
      </extension>
    </answer>
  </item>
  <item>
    <linkId value="9"/>
    <extension url="http://hl7.org/fhir/StructureDefinition/rendering-xhtml">
      <valueXhtml/>
    </extension>
    <answer>
      <extension
                 url="http://hl7.org/fhir/StructureDefinition/rendering-xhtml">
        <valueXhtml/>
      </extension>
    </answer>
  </item>
  <item>
    <linkId value="10"/>
    <extension url="http://hl7.org/fhir/StructureDefinition/rendering-xhtml">
      <valueXhtml/>
    </extension>
    <answer>
      <extension
                 url="http://hl7.org/fhir/StructureDefinition/rendering-xhtml">
        <valueXhtml/>
      </extension>
    </answer>
  </item>
</QuestionnaireResponse>