API for the Exchange of Medicinal Product Information (APIX)
0.1.0 - ci-build
API for the Exchange of Medicinal Product Information (APIX)
0.1.0 - ci-build
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
| Page standards status: Informative |
<Task xmlns="http://hl7.org/fhir">
<id value="scenario1-07-final-decision"/>
<meta>
<versionId value="3"/>
<lastUpdated value="2026-04-20T09:00:00+01:00"/>
<profile
value="http://hl7.org/fhir/uv/apix/StructureDefinition/apix-task"/>
</meta>
<text>
<status value="generated"/>
<div xmlns="http://www.w3.org/1999/xhtml"><p class="res-header-id"><b>Generated Narrative: Task scenario1-07-final-decision</b></p><a name="scenario1-07-final-decision"> </a><a name="hcscenario1-07-final-decision"> </a><div style="display: inline-block; background-color: #d9e0e7; padding: 6px; margin: 4px; border: 1px solid #8da1b4; border-radius: 5px; line-height: 60%"><p style="margin-bottom: 0px">version: 3; Last updated: 2026-04-20 09:00:00+0100</p><p style="margin-bottom: 0px">Profile: <a href="StructureDefinition-apix-task.html">APIX Regulatory Task</a></p></div><p><b>identifier</b>: Resource identifier/urn:uuid:f1500e1d-599f-47a6-a38c-ca60a5189726 (use: official, )</p><p><b>groupIdentifier</b>: <code>http://example.org/european-med-agency/work-flow-group-id</code>/urn:uuid:workflow-group-id-12345 (use: official, )</p><p><b>status</b>: Completed</p><p><b>businessStatus</b>: <span title="Codes:{http://hl7.org/fhir/uv/apix/CodeSystem/apix-business-status approved}">Approved</span></p><p><b>intent</b>: proposal</p><p><b>priority</b>: Routine</p><p><b>code</b>: <span title="Codes:{http://hl7.org/fhir/uv/apix/CodeSystem/apix-task-code variation-type-ib}">Type IB Variation</span></p><p><b>authoredOn</b>: 2025-11-15 09:00:00+0100</p><p><b>lastModified</b>: 2026-04-20 09:00:00+0100</p><p><b>requester</b>: <a href="Organization-org-synthpharma-ag.html">SynthPharma AG</a></p><p><b>owner</b>: <a href="Organization-org-ema-srm-hmed.html">European Medicines Agency</a></p><blockquote><p><b>input</b></p><p><b>type</b>: <span title="Codes:{http://hl7.org/fhir/uv/apix/CodeSystem/ctd-section 1.0}">Cover Letter</span></p><p><b>value</b>: <a href="DocumentReference-doc1.html">DocumentReference: version = 1.0; status = current; docStatus = final; type = Cover Letter; category = Module 1</a></p></blockquote><blockquote><p><b>input</b></p><p><b>type</b>: <span title="Codes:">Application Form</span></p><p><b>value</b>: <a href="DocumentReference-doc2.html">DocumentReference: version = 1.0; status = current; docStatus = final; type = Application Form; category = Module 1</a></p></blockquote><blockquote><p><b>input</b></p><p><b>type</b>: <span title="Codes:{http://hl7.org/fhir/uv/apix/CodeSystem/ctd-section 1.3.1}">SPC, Labelling and Package Leaflet</span></p><p><b>value</b>: <a href="DocumentReference-doc3.html">DocumentReference: version = 1.0; status = current; docStatus = final; type = SPC, Labelling and Package Leaflet; category = Module 1</a></p></blockquote><blockquote><p><b>input</b></p><p><b>type</b>: <span title="Codes:{http://hl7.org/fhir/uv/apix/CodeSystem/ctd-section 1.3.1}">SPC, Labelling and Package Leaflet</span></p><p><b>value</b>: <a href="DocumentReference-doc4.html">DocumentReference: version = 1.0; status = current; docStatus = final; type = SPC, Labelling and Package Leaflet; category = Module 1</a></p></blockquote><blockquote><p><b>input</b></p><p><b>type</b>: <span title="Codes:{http://hl7.org/fhir/uv/apix/CodeSystem/ctd-section 1.3.2}">Mock-ups</span></p><p><b>value</b>: <a href="DocumentReference-doc5.html">DocumentReference: version = 1.0; status = current; docStatus = final; type = Mock-ups</a></p></blockquote><blockquote><p><b>input</b></p><p><b>type</b>: <span title="Codes:{http://hl7.org/fhir/uv/apix/CodeSystem/ctd-section 3.2.P.8.1}">Stability Summary and Conclusion</span></p><p><b>value</b>: <a href="DocumentReference-doc6.html">DocumentReference: version = 1.0; status = current; docStatus = final; type = Stability Summary and Conclusion; category = Module 3</a></p></blockquote><blockquote><p><b>input</b></p><p><b>type</b>: <span title="Codes:{http://hl7.org/fhir/uv/apix/CodeSystem/ctd-section 3.2.P.8.3}">Stability Data</span></p><p><b>value</b>: <a href="DocumentReference-doc7.html">DocumentReference: version = 1.0; status = current; docStatus = final; type = Stability Data; category = Module 3</a></p></blockquote><blockquote><p><b>input</b></p><p><b>type</b>: <span title="Codes:{http://hl7.org/fhir/uv/apix/CodeSystem/ctd-section 3.2.S.7}">Stability (Drug Substance)</span></p><p><b>value</b>: <a href="DocumentReference-doc8.html">DocumentReference: version = 1.0; status = current; docStatus = final; type = Stability (Drug Substance); category = Module 3</a></p></blockquote><blockquote><p><b>output</b></p><p><b>type</b>: <span title="Codes:{http://hl7.org/fhir/uv/apix/CodeSystem/apix-task-input-type cover-letter}">Cover Letter</span></p><p><b>value</b>: <a href="DocumentReference-docref-approval-letter.html">Approval Letter</a></p></blockquote><blockquote><p><b>output</b></p><p><b>type</b>: <span title="Codes:{http://hl7.org/fhir/uv/apix/CodeSystem/apix-task-input-type cover-letter}">Cover Letter</span></p><p><b>value</b>: <a href="DocumentReference-docref-assessment-report.html">Final Assessment Report</a></p></blockquote></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:workflow-group-id-12345"/>
</groupIdentifier>
<status value="completed"/>
<businessStatus>
<coding>
<system
value="http://hl7.org/fhir/uv/apix/CodeSystem/apix-business-status"/>
<code value="approved"/>
<display value="Approved"/>
</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="2026-04-20T09:00:00+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>
<output>
<type>
<coding>
<system
value="http://hl7.org/fhir/uv/apix/CodeSystem/apix-task-input-type"/>
<code value="cover-letter"/>
<display value="Cover Letter"/>
</coding>
</type>
<valueReference>🔗
<reference value="DocumentReference/docref-approval-letter"/>
<display value="Approval Letter"/>
</valueReference>
</output>
<output>
<type>
<coding>
<system
value="http://hl7.org/fhir/uv/apix/CodeSystem/apix-task-input-type"/>
<code value="cover-letter"/>
<display value="Cover Letter"/>
</coding>
</type>
<valueReference>🔗
<reference value="DocumentReference/docref-assessment-report"/>
<display value="Final Assessment Report"/>
</valueReference>
</output>
</Task>