API for the Exchange of Medicinal Product Information (APIX)
0.1.0 - ci-build International flag

API for the Exchange of Medicinal Product Information (APIX), 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

: scenario1 06 technical response

Page standards status: Informative

Raw xml | Download


<Task xmlns="http://hl7.org/fhir">
  <id value="scenario1-06-technical-response"/>
  <meta>
    <versionId value="3"/>
    <lastUpdated value="2025-12-05T10:00:00+01:00"/>
    <profile
             value="http://hl7.org/fhir/uv/apix/StructureDefinition/apix-task"/>
  </meta>
  <language value="en"/>
  <text>
    <status value="additional"/>
    <div xml:lang="en" xmlns="http://www.w3.org/1999/xhtml" lang="en"><div style="font-family:-apple-system,BlinkMacSystemFont,'Segoe UI',Roboto,Helvetica,Arial,sans-serif;background:linear-gradient(to bottom,#f2f6fa,#e8eef5);color:#1d1d1f;margin:0;padding:40px 20px;line-height:1.5;"><div style="max-width:1000px;margin:0 auto;"><div style="background:linear-gradient(135deg,#007aff,#5ac8fa);color:#ffffff;padding:40px 24px;border-radius:18px;text-align:center;box-shadow:0 10px 30px rgba(0,122,255,0.3);margin-bottom:36px;"><div style="margin:0 0 8px 0;font-size:32px;font-weight:600;">Task: Response to Information Request</div><p style="margin:0;opacity:0.95;font-size:17px;">HL7 FHIR R5 – APIX Implementation Guide</p></div><div style="background:#ffffff;border-radius:18px;padding:32px;margin-bottom:32px;box-shadow:0 8px 28px rgba(0,0,0,0.08),0 2px 10px rgba(0,0,0,0.06);"><div style="font-size:24px;font-weight:600;color:#007aff;margin:0 0 24px 0;padding-bottom:12px;border-bottom:1px solid #e5e5ea;display:flex;justify-content:space-between;align-items:center;">Task Description</div><div style="font-size:18px;line-height:1.6;color:#333333;">Response to Questions: Submission of additional stability data</div></div><div style="background:#ffffff;border-radius:18px;padding:32px;margin-bottom:32px;box-shadow:0 8px 28px rgba(0,0,0,0.08),0 2px 10px rgba(0,0,0,0.06);"><div style="font-size:24px;font-weight:600;color:#007aff;margin:0 0 24px 0;padding-bottom:12px;border-bottom:1px solid #e5e5ea;display:flex;justify-content:space-between;align-items:center;">Core Task Information</div><div style="display:grid;grid-template-columns:max-content auto;gap:12px 20px;align-items:baseline;"><span style="font-weight:600;color:#555555;text-align:right;min-width:150px;">Version ID</span><span style="color:#1d1d1f;">3</span><span style="font-weight:600;color:#555555;text-align:right;min-width:150px;">Task ID</span><span style="color:#1d1d1f;">In production this would be the same as scenario1-05-technical-question</span><span style="font-weight:600;color:#555555;text-align:right;min-width:150px;">Instance UUID</span><span style="color:#1d1d1f;">urn:uuid:888e7d2a-8b1c-4d9f-9a2e-1f6c9d8e7b3c</span><span style="font-weight:600;color:#555555;text-align:right;min-width:150px;">Group Identifier</span><span style="color:#1d1d1f;">urn:uuid:workflow-group-id-12345</span><span style="font-weight:600;color:#555555;text-align:right;min-width:150px;">Parent Task</span><span style="color:#1d1d1f;">scenario1-01-initial-submission</span><span style="font-weight:600;color:#555555;text-align:right;min-width:150px;">Task Status</span><span style="color:#1d1d1f;"><span style="padding:2px 8px;border-radius:12px;font-size:0.9em;font-weight:500;color:#ffffff;background:#17a2b8;">requested</span></span><span style="font-weight:600;color:#555555;text-align:right;min-width:150px;">Business Status</span><span style="color:#1d1d1f;"><span style="padding:2px 8px;border-radius:12px;font-size:0.9em;font-weight:500;color:#ffffff;background:#6c757d;">Submitted</span></span><span style="font-weight:600;color:#555555;text-align:right;min-width:150px;">Intent</span><span style="color:#1d1d1f;">proposal</span><span style="font-weight:600;color:#555555;text-align:right;min-width:150px;">Priority</span><span style="color:#1d1d1f;">routine</span></div><hr style="border:0;border-top:1px solid #eee;margin:20px 0;"/><div style="display:grid;grid-template-columns:max-content auto;gap:12px 20px;align-items:baseline;"><span style="font-weight:600;color:#555555;text-align:right;min-width:150px;">Code</span><span style="color:#1d1d1f;">Response to Information Request (response-to-questions)</span><span style="font-weight:600;color:#555555;text-align:right;min-width:150px;">Authored</span><span style="color:#1d1d1f;">2025-12-01T14:30:00+01:00</span><span style="font-weight:600;color:#555555;text-align:right;min-width:150px;">Last Updated</span><span style="color:#1d1d1f;">2025-12-05T10:00:00+01:00</span> <span style="font-weight:600;color:#555555;text-align:right;min-width:150px;">Request Start Time</span><span style="color:#1d1d1f;">2025-12-01T14:30:00+01:00</span> <span style="font-weight:600;color:#555555;text-align:right;min-width:150px;">Request Answer By</span><span style="color:#1d1d1f;">2025-12-08T14:30:00+01:00</span></div></div><div style="background:#ffffff;border-radius:18px;padding:32px;margin-bottom:32px;box-shadow:0 8px 28px rgba(0,0,0,0.08),0 2px 10px rgba(0,0,0,0.06);"><div style="font-size:24px;font-weight:600;color:#007aff;margin:0 0 24px 0;padding-bottom:12px;border-bottom:1px solid #e5e5ea;display:flex;justify-content:space-between;align-items:center;">Parties Involved</div><div style="margin-bottom:24px;padding-bottom:16px;border-bottom:1px solid #eeeeee;"><span style="font-weight:600;color:#007aff;margin-bottom:4px;display:block;">Requester</span><div style="font-size:16px;font-weight:500;margin-bottom:8px;color:#1d1d1f;">SynthPharma AG</div><div style="font-size:14px;color:#555555;line-height:1.5;"><strong>Address:</strong> 123 Synthetic Research Blvd, 4000 Basel, Switzerland<br/><strong>Contact:</strong> Dr. John Doe, Head of Regulatory Affairs<br/><strong>Email:</strong> john.doe@synthpharma.example</div></div><div style="margin-bottom:0;padding-bottom:0;border-bottom:none;"><span style="font-weight:600;color:#007aff;margin-bottom:4px;display:block;">Performer</span><div style="font-size:16px;font-weight:500;margin-bottom:8px;color:#1d1d1f;">European Medicines Agency – Human Medicines Evaluation Division</div><div style="font-size:14px;color:#555555;line-height:1.5;"><strong>Address:</strong> Domenico Scarlattilaan 6, 1083 HS Amsterdam, Netherlands<br/><strong>Contact:</strong> Scientific and Regulatory Management<br/><strong>Email:</strong> srm@ema.example.eu</div></div></div><div style="background:#ffffff;border-radius:18px;padding:32px;margin-bottom:32px;box-shadow:0 8px 28px rgba(0,0,0,0.08),0 2px 10px rgba(0,0,0,0.06);"><div style="font-size:24px;font-weight:600;color:#007aff;margin:0 0 24px 0;padding-bottom:12px;border-bottom:1px solid #e5e5ea;display:flex;justify-content:space-between;align-items:center;">Input Documents<span style="background:#007aff;color:#ffffff;font-size:14px;font-weight:600;padding:6px 14px;border-radius:20px;">1 documents</span></div><div style="margin:24px 0;padding:20px;background:#f8fbff;border-radius:14px;border-left:5px solid #007aff;"><div style="margin:0 0 16px 0;font-size:18px;color:#007aff;font-weight:600;">Input Documents (Questions)</div><div style="background:#ffffff;border:1px solid #d1e4ff;border-radius:12px;padding:16px;margin-bottom:12px;box-shadow:0 2px 8px rgba(0,0,0,0.05);"><div style="font-weight:600;color:#007aff;font-size:15px;">List of Questions (LoQ)</div><span style="font-family:Menlo,Monaco,Consolas,monospace;background:#e5f2ff;padding:2px 8px;border-radius:6px;font-size:13px;">regulatory-document</span><br/><a href="DocumentReference-docref-list-of-questions.html">http://example.org/FHIR/DocumentReference/docref-list-of-questions</a><div>list of questions</div></div></div></div><div style="background:#ffffff;border-radius:18px;padding:32px;margin-bottom:32px;box-shadow:0 8px 28px rgba(0,0,0,0.08),0 2px 10px rgba(0,0,0,0.06);"><div style="font-size:24px;font-weight:600;color:#007aff;margin:0 0 24px 0;padding-bottom:12px;border-bottom:1px solid #e5e5ea;display:flex;justify-content:space-between;align-items:center;">Output Documents<span style="background:#34c759;color:#ffffff;font-size:14px;font-weight:600;padding:6px 14px;border-radius:20px;">2 documents</span></div><div style="margin:24px 0;padding:20px;background:#f2fff5;border-radius:14px;border-left:5px solid #34c759;"><div style="margin:0 0 16px 0;font-size:18px;color:#34c759;font-weight:600;">Output Documents (Responses)</div><div style="background:#ffffff;border:1px solid #ccebd3;border-radius:12px;padding:16px;margin-bottom:12px;box-shadow:0 2px 8px rgba(0,0,0,0.05);"><div style="font-weight:600;color:#34c759;font-size:15px;">Applicant Responses</div><span style="font-family:Menlo,Monaco,Consolas,monospace;background:#e6f9eb;padding:2px 8px;border-radius:6px;font-size:13px;">regulatory-document</span><br/><a href="DocumentReference-docref-responses-qresponse.html">http://example.org/FHIR/DocumentReference/docref-responses-qresponse</a><div>Applicant QuestionnaireResponse</div></div><div style="background:#ffffff;border:1px solid #ccebd3;border-radius:12px;padding:16px;margin-bottom:12px;box-shadow:0 2px 8px rgba(0,0,0,0.05);"><div style="font-weight:600;color:#34c759;font-size:15px;">Annex: Raw Stability Data</div><span style="font-family:Menlo,Monaco,Consolas,monospace;background:#e6f9eb;padding:2px 8px;border-radius:6px;font-size:13px;">regulatory-document</span><br/><a href="DocumentReference-docref-stability-data-annex.html">http://example.org/FHIR/DocumentReference/docref-stability-data-annex</a><div>Annex: Updated Stability Data</div></div><div style="text-align:center;padding:50px;color:#666666;font-size:14px;">HL7 FHIR R5 – API Exchange for Medicinal Products (APIX)<br/>Generated Render</div></div></div></div></div></div>
  </text>
  <identifier>
    <type>
      <coding>
        <system value="http://terminology.hl7.org/CodeSystem/v2-0203"/>
        <code value="RI"/>
        <display value="Resource identifier"/>
      </coding>
    </type>
    <system value="http://example.org/european-med-agency/task-id"/>
    <value value="urn:uuid:778e7d2a-8b1c-4d9f-9a2e-1f6c9d8e7b3b"/>
  </identifier>
  <basedOn>🔗 
    <reference value="Task/scenario1-01-initial-submission"/>
    <display value="Initial Submission Task"/>
  </basedOn>
  <groupIdentifier>
    <use value="official"/>
    <system
            value="http://example.org/european-med-agency/work-flow-group-id"/>
    <value value="urn:uuid:workflow-group-id-12345"/>
  </groupIdentifier>
  <status value="completed"/>
  <businessStatus>
    <coding>
      <system
              value="http://hl7.org/fhir/uv/apix/CodeSystem/apix-business-status"/>
      <code value="clock-stop"/>
      <display value="Clock Stop"/>
    </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="2025-12-01T14:30:00+01:00"/>
    <end value="2025-12-08T14:30:00+01:00"/>
  </requestedPeriod>
  <authoredOn value="2025-12-01T14:30:00+01:00"/>
  <lastModified value="2025-12-05T10:00:00+01:00"/>
  <requester>🔗 
    <reference value="Organization/org-ema-srm-hmed"/>
    <display value="European Medicines Agency"/>
  </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/ctd-section"/>
        <code value="list-of-questions"/>
        <display value="List of Questions"/>
      </coding>
    </type>
    <valueReference>🔗 
      <reference value="DocumentReference/docref-list-of-questions"/>
      <display value="List of Questions (LoQ)"/>
    </valueReference>
  </input>
  <output>
    <type>
      <coding>
        <system value="http://hl7.org/fhir/uv/apix/CodeSystem/ctd-section"/>
        <code value="applicant-questionnaireResponse&quot;"/>
        <display value="Applicant QuestionnaireResponse"/>
      </coding>
    </type>
    <valueReference>🔗 
      <reference value="DocumentReference/docref-responses-qresponse"/>
      <display value="Applicant QuestionnaireResponse"/>
    </valueReference>
  </output>
  <output>
    <type>
      <coding>
        <system value="http://hl7.org/fhir/uv/apix/CodeSystem/ctd-section"/>
        <code value="3.2.P.8.3"/>
        <display value="Stability Data"/>
      </coding>
    </type>
    <valueReference>🔗 
      <reference value="DocumentReference/docref-stability-data-annex"/>
      <display value="Annex: Updated Stability Data"/>
    </valueReference>
  </output>
</Task>