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 01 initial submission

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<Task xmlns="http://hl7.org/fhir">
  <id value="scenario1-01-initial-submission"/>
  <meta>
    <versionId value="1"/>
    <lastUpdated value="2025-11-15T09:00:00+01:00"/>
    <profile
             value="http://hl7.org/fhir/uv/apix/StructureDefinition/apix-task"/>
  </meta>
  <language value="en"/>
  <text>
    <status value="additional"/>
    <div xmlns="http://www.w3.org/1999/xhtml"><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: Type IB Variation</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;">Type IB Variation</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;">1</span><span style="font-weight:600;color:#555555;text-align:right;min-width:150px;">Task ID</span><span style="color:#1d1d1f;">task-workflow-step1</span><span style="font-weight:600;color:#555555;text-align:right;min-width:150px;">Instance UUID</span><span style="color:#1d1d1f;">urn:uuid:workflow-step1-instance</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;">Procedure ID</span><span style="color:#1d1d1f;">not yet assigned</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:#007aff;">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:#8e8e93;">Submitted</span></span><span style="font-weight:600;color:#555555;text-align:right;min-width:150px;">Intent</span><span style="color:#1d1d1f;">order</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 #eeeeee;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;">Type IB Variation (variation-type-ib)</span><span style="font-weight:600;color:#555555;text-align:right;min-width:150px;">Authored</span><span style="color:#1d1d1f;">2025-11-15 09:00:00 UTC+01:00</span><span style="font-weight:600;color:#555555;text-align:right;min-width:150px;">Last Updated</span><span style="color:#1d1d1f;">2025-11-15 09:00:00 UTC+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;">10 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;">Module 1</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;">Cover Letter</div><span style="font-family:Menlo,Monaco,Consolas,monospace;background:#e5f2ff;padding:2px 8px;border-radius:6px;font-size:13px;">cover-letter</span><br/>Cover Letter.pdf</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;">Application Form</div><span style="font-family:Menlo,Monaco,Consolas,monospace;background:#e5f2ff;padding:2px 8px;border-radius:6px;font-size:13px;">application-form</span><br/>Application Form.pdf</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;">Annotated Label</div><span style="font-family:Menlo,Monaco,Consolas,monospace;background:#e5f2ff;padding:2px 8px;border-radius:6px;font-size:13px;">annotated-label</span><br/>Annotated Label.pdf</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;">Clean Label</div><span style="font-family:Menlo,Monaco,Consolas,monospace;background:#e5f2ff;padding:2px 8px;border-radius:6px;font-size:13px;">clean-label</span><br/>Clean Label.pdf</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;">Pack Mockup</div><span style="font-family:Menlo,Monaco,Consolas,monospace;background:#e5f2ff;padding:2px 8px;border-radius:6px;font-size:13px;">pack-mockup</span><br/>Pack Mockup.pdf</div></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;">Module 3</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;">Stability Summary</div><span style="font-family:Menlo,Monaco,Consolas,monospace;background:#e5f2ff;padding:2px 8px;border-radius:6px;font-size:13px;">cmc-stability-summary</span><br/>CMC Doc 1 - Summary.pdf</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;">Stability Data</div><span style="font-family:Menlo,Monaco,Consolas,monospace;background:#e5f2ff;padding:2px 8px;border-radius:6px;font-size:13px;">cmc-stability-data</span><br/>CMC Doc 2 - Data.pdf</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;">Stability Commitment</div><span style="font-family:Menlo,Monaco,Consolas,monospace;background:#e5f2ff;padding:2px 8px;border-radius:6px;font-size:13px;">cmc-stability-commitment</span><br/>CMC Doc 3 - Commitment.pdf</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;">DS Stability Summary</div><span style="font-family:Menlo,Monaco,Consolas,monospace;background:#e5f2ff;padding:2px 8px;border-radius:6px;font-size:13px;">cmc-ds-stability-summary</span><br/>CMC Doc 4 - DS Summary.pdf</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;">DS Stability Data</div><span style="font-family:Menlo,Monaco,Consolas,monospace;background:#e5f2ff;padding:2px 8px;border-radius:6px;font-size:13px;">cmc-ds-stability-data</span><br/>CMC Doc 5 - DS Data.pdf</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</div><div style="text-align:center;padding:40px 20px;color:#888888;background:#f9f9f9;border-radius:14px;">No output content defined in this render script.</div></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>
  </text>
  <identifier>
    <use value="official"/>
    <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:f1500e1d-599f-47a6-a38c-ca60a5189726"/>
  </identifier>
  <groupIdentifier>
    <use value="official"/>
    <system
            value="http://example.org/european-med-agency/work-flow-group-id"/>
    <value value="urn:uuid:f1500e1d-599f-47a6-a38c-ca60a5189727"/>
  </groupIdentifier>
  <status value="requested"/>
  <businessStatus>
    <coding>
      <system
              value="http://hl7.org/fhir/uv/apix/CodeSystem/apix-business-status"/>
      <code value="submitted"/>
      <display value="Submitted"/>
    </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-ib"/>
      <display value="Type IB Variation"/>
    </coding>
  </code>
  <authoredOn value="2025-11-15T09:00:00+01:00"/>
  <lastModified value="2025-11-15T09:00:00+01:00"/>
  <requester>🔗 
    <reference value="Organization/org-synthpharma-ag"/>
    <display value="SynthPharma AG"/>
  </requester>
  <owner>🔗 
    <reference value="Organization/org-ema-srm-hmed"/>
    <display value="European Medicines Agency"/>
  </owner>
  <input>
    <type>
      <coding>
        <system value="http://hl7.org/fhir/uv/apix/CodeSystem/ctd-section"/>
        <code value="1.0"/>
        <display value="Cover Letter"/>
      </coding>
    </type>
    <valueReference>🔗 
      <reference value="DocumentReference/doc1"/>
    </valueReference>
  </input>
  <input>
    <type>
      <coding>
        <code value="application-form"/>
        <display value="Application Form"/>
      </coding>
    </type>
    <valueReference>🔗 
      <reference value="DocumentReference/doc2"/>
    </valueReference>
  </input>
  <input>
    <type>
      <coding>
        <system value="http://hl7.org/fhir/uv/apix/CodeSystem/ctd-section"/>
        <code value="1.3.1"/>
        <display value="SPC, Labelling and Package Leaflet"/>
      </coding>
    </type>
    <valueReference>🔗 
      <reference value="DocumentReference/doc3"/>
    </valueReference>
  </input>
  <input>
    <type>
      <coding>
        <system value="http://hl7.org/fhir/uv/apix/CodeSystem/ctd-section"/>
        <code value="1.3.1"/>
        <display value="SPC, Labelling and Package Leaflet"/>
      </coding>
    </type>
    <valueReference>🔗 
      <reference value="DocumentReference/doc4"/>
    </valueReference>
  </input>
  <input>
    <type>
      <coding>
        <system value="http://hl7.org/fhir/uv/apix/CodeSystem/ctd-section"/>
        <code value="1.3.2"/>
        <display value="Mock-ups"/>
      </coding>
    </type>
    <valueReference>🔗 
      <reference value="DocumentReference/doc5"/>
    </valueReference>
  </input>
  <input>
    <type>
      <coding>
        <system value="http://hl7.org/fhir/uv/apix/CodeSystem/ctd-section"/>
        <code value="3.2.P.8.1"/>
        <display value="Stability Summary and Conclusion"/>
      </coding>
    </type>
    <valueReference>🔗 
      <reference value="DocumentReference/doc6"/>
    </valueReference>
  </input>
  <input>
    <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/doc7"/>
    </valueReference>
  </input>
  <input>
    <type>
      <coding>
        <system value="http://hl7.org/fhir/uv/apix/CodeSystem/ctd-section"/>
        <code value="3.2.S.7"/>
        <display value="Stability (Drug Substance)"/>
      </coding>
    </type>
    <valueReference>🔗 
      <reference value="DocumentReference/doc8"/>
    </valueReference>
  </input>
</Task>