API for the Exchange of Medicinal Product Information (APIX), published by Gravitate Health Project. 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

: ema-questionnaire-request-001 - XML Representation

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<Task xmlns="http://hl7.org/fhir">
  <id value="ema-questionnaire-request-001"/>
  <meta>
    <versionId value="1"/>
    <lastUpdated value="2025-11-13T09:15:00Z"/>
  </meta>
  <!--  Narrative with proper escaping and contact names  -->
  <text>
    <status value="generated"/>
    <div xmlns="http://www.w3.org/1999/xhtml">
      <p>EMA requests AcmePharm to complete structured questionnaire on post-market pediatric safety data for Aspirin 100mg Tablets.</p>
      <p><b>From:</b> Dr. Elena Rossi, EMA Pharmacovigilance Unit (elena.rossi@ema.europa.eu)</p>
      <p><b>To:</b> Mr. James Carter, AcmePharm Regulatory Affairs (james.carter@acmepharm.com)</p>
    </div>
  </text>
  <!--  Sponsor-defined identifier  -->
  <identifier>
    <use value="official"/>
    <system value="https://acmepharm.com/identifiers/task"/>
    <value value="ACME-REQ-2025-078"/>
  </identifier>
  <!--  Regulator-defined identifier  -->
  <identifier>
    <use value="official"/>
    <system value="https://ema.europa.eu/identifiers/task"/>
    <value value="EMA-INFOREQ-2025-112"/>
  </identifier>
  <groupIdentifier>
    <value value="GRP-2025-PV-EMA-EU"/>
  </groupIdentifier>
  <status value="requested"/>
  <intent value="proposal"/>
  <code>
    <coding>
      <system value="http://hl7.org/fhir/CodeSystem/task-code"/>
      <code value="questionnaire-distribution"/>
      <display value="Questionnaire Distribution"/>
    </coding>
  </code>
  <description
               value="EMA issues structured questionnaire to AcmePharm regarding observed adverse reactions and usage patterns for Aspirin 100mg Tablets in pediatric populations."/>
  <authoredOn value="2025-11-13T08:00:00Z"/>
  <lastModified value="2025-11-13T09:15:00Z"/>
  <!--  Requester: EMA  -->
  <requester>
    <reference value="#ema-org"/>
    <display value="European Medicines Agency (EMA)"/>
  </requester>
  <!--  Requested Performer: AcmePharm  -->
  <requestedPerformer>
    <reference/>
  </requestedPerformer>
  <!--  Owner: AcmePharm  -->
  <owner>
    <reference value="#acmepharm-org"/>
    <display value="Acme Pharmaceuticals Inc."/>
  </owner>
  <requestedPeriod>
    <start value="2025-11-13"/>
    <end value="2025-11-27"/>
  </requestedPeriod>
  <contained>
    <Organization>
      <id value="ema-org"/>
      <name value="European Medicines Agency (EMA)"/>
      <contact>
        <!--  Use standard contact purpose via code (no extension needed)  -->
        <purpose>
          <coding>
            <system
                    value="http://terminology.hl7.org/CodeSystem/contactentity-type"/>
            <code value="ADMIN"/>
            <display value="Administrative"/>
          </coding>
          <text value="Regulatory Contact"/>
        </purpose>
        <name>
          <use value="official"/>
          <family value="Rossi"/>
          <given value="Elena"/>
          <prefix value="Dr."/>
        </name>
        <telecom>
          <system value="email"/>
          <value value="elena.rossi@ema.europa.eu"/>
          <use value="work"/>
        </telecom>
        <telecom>
          <system value="phone"/>
          <value value="+31-88-781-6000"/>
          <use value="work"/>
        </telecom>
      </contact>
    </Organization>
  </contained>
  <contained>
    <Organization>
      <id value="acmepharm-org"/>
      <name value="Acme Pharmaceuticals Inc."/>
      <contact>
        <purpose>
          <coding>
            <system
                    value="http://terminology.hl7.org/CodeSystem/contactentity-type"/>
            <code value="ADMIN"/>
            <display value="Administrative"/>
          </coding>
          <text value="Response Contact"/>
        </purpose>
        <name>
          <use value="official"/>
          <family value="Carter"/>
          <given value="James"/>
          <prefix value="Mr."/>
        </name>
        <telecom>
          <system value="email"/>
          <value value="james.carter@acmepharm.com"/>
          <use value="work"/>
        </telecom>
        <telecom>
          <system value="phone"/>
          <value value="+1-555-123-4567"/>
          <use value="work"/>
        </telecom>
      </contact>
    </Organization>
  </contained>
  <contained>
    <Questionnaire>
      <id value="ema-pediatric-safety-q1"/>
      <url
           value="http://ema.europa.eu/questionnaire/2025/pediatric-aspirin-safety-v1"/>
      <version value="1.0"/>
      <status value="draft"/>
      <title
             value="Post-Market Pediatric Safety Data Request – Aspirin 100mg"/>
      <subjectType value="MedicinalProduct"/>
      <item>
        <linkId value="1"/>
        <text value="Number of pediatric AE reports in past 12 months"/>
        <type value="integer"/>
      </item>
    </Questionnaire>
  </contained>
  <!--  Input: Base64-encoded Questionnaire payload  -->
  <input>
    <type>
      <coding>
        <system value="http://hl7.org/fhir/ValueSet/task-input-type"/>
        <code value="attachment"/>
        <display value="Attachment"/>
      </coding>
    </type>
    <valueAttachment>
      <contentType value="application/fhir+xml"/>
      <data value=""/>
      <title value="EMA_Pediatric_Safety_Questionnaire_v1.xml"/>
      <creation value="2025-11-13T08:00:00Z"/>
    </valueAttachment>
  </input>
  <!--  Input: Reference to contained Questionnaire (prevents orphaning)  -->
  <input>
    <type>
      <coding>
        <system value="http://hl7.org/fhir/ValueSet/task-input-type"/>
        <code value="reference"/>
        <display value="Reference"/>
      </coding>
    </type>
    <valueReference>
      <reference value="#ema-pediatric-safety-q1"/>
    </valueReference>
  </input>
</Task>