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 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
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<id value="task-nda-submission-index-2025"/>
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<lastUpdated value="2025-12-20T14:15:00Z"/>
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<div xmlns="http://www.w3.org/1999/xhtml"><p class="res-header-id"><b>Generated Narrative: Task task-nda-submission-index-2025</b></p><a name="task-nda-submission-index-2025"> </a><a name="hctask-nda-submission-index-2025"> </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: 1; Last updated: 2025-12-20 14:15:00+0000</p><p style="margin-bottom: 0px">Profile: <a href="StructureDefinition-apix-task.html">APIX Regulatory Task</a></p></div><p><b>identifier</b>: Task Instance UUID/urn:uuid:8e4d2a-8b1c-4d9f-9a2e-nda-example (use: official, )</p><p><b>status</b>: Requested</p><p><b>intent</b>: order</p><p><b>priority</b>: Routine</p><p><b>code</b>: <span title="Codes:{http://hl7.org/fhir/uv/apix/CodeSystem/apix-task-type new-drug-application}">New Drug Application (NDA)</span></p><p><b>authoredOn</b>: 2025-12-20 14:15:00+0000</p><p><b>lastModified</b>: 2025-12-20 14:15:00+0000</p><p><b>requester</b>: <a href="#hctask-nda-submission-index-2025/org-synthpharma-ag">Organization SynthPharma AG</a></p><p><b>owner</b>: <a href="#hctask-nda-submission-index-2025/org-ema">Organization 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/apix-task-input-type regulatory-document}">regulatory-document</span></p><p><b>value</b>: <a href="#hctask-nda-submission-index-2025/docref-m1-cover">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:{http://hl7.org/fhir/uv/apix/CodeSystem/apix-task-input-type regulatory-document}">regulatory-document</span></p><p><b>value</b>: <a href="#hctask-nda-submission-index-2025/docref-m3-stability-data">DocumentReference: version = 1.0; status = current; docStatus = final; type = Stability; 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/apix-task-input-type regulatory-document}">regulatory-document</span></p><p><b>value</b>: <a href="#hctask-nda-submission-index-2025/docref-m5-clinical-study">DocumentReference: version = 1.0; status = current; docStatus = final; type = Reports of Efficacy and Safety Studies; category = Module 5</a></p></blockquote><hr/><blockquote><p class="res-header-id"><b>Generated Narrative: Organization #org-synthpharma-ag</b></p><a name="task-nda-submission-index-2025/org-synthpharma-ag"> </a><a name="hctask-nda-submission-index-2025/org-synthpharma-ag"> </a><p><b>name</b>: SynthPharma AG</p></blockquote><hr/><blockquote><p class="res-header-id"><b>Generated Narrative: Organization #org-ema</b></p><a name="task-nda-submission-index-2025/org-ema"> </a><a name="hctask-nda-submission-index-2025/org-ema"> </a><p><b>name</b>: European Medicines Agency</p></blockquote><hr/><blockquote><p class="res-header-id"><b>Generated Narrative: DocumentReference #docref-m1-cover</b></p><a name="task-nda-submission-index-2025/docref-m1-cover"> </a><a name="hctask-nda-submission-index-2025/docref-m1-cover"> </a><p><b>version</b>: 1.0</p><p><b>status</b>: Current</p><p><b>docStatus</b>: Final</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>category</b>: <span title="Codes:{http://hl7.org/fhir/uv/apix/CodeSystem/ctd-module m1}">Module 1</span></p><blockquote><p><b>content</b></p><h3>Attachments</h3><table class="grid"><tr><td style="display: none">-</td><td><b>ContentType</b></td><td><b>Url</b></td><td><b>Size</b></td><td><b>Title</b></td><td><b>Creation</b></td></tr><tr><td style="display: none">*</td><td>application/pdf</td><td><a href="https://api.synthpharma.example/binaries/nda-12345/m1/cover-letter.pdf">https://api.synthpharma.example/binaries/nda-12345/m1/cover-letter.pdf</a></td><td>1250000</td><td>Cover Letter.pdf</td><td>2025-12-20 14:00:00+0000</td></tr></table></blockquote></blockquote><hr/><blockquote><p class="res-header-id"><b>Generated Narrative: DocumentReference #docref-m3-stability-data</b></p><a name="task-nda-submission-index-2025/docref-m3-stability-data"> </a><a name="hctask-nda-submission-index-2025/docref-m3-stability-data"> </a><p><b>version</b>: 1.0</p><p><b>status</b>: Current</p><p><b>docStatus</b>: Final</p><p><b>type</b>: <span title="Codes:{http://hl7.org/fhir/uv/apix/CodeSystem/ctd-section 3.2.P.8}">Stability</span></p><p><b>category</b>: <span title="Codes:{http://hl7.org/fhir/uv/apix/CodeSystem/ctd-module m3}">Module 3</span></p><blockquote><p><b>content</b></p><h3>Attachments</h3><table class="grid"><tr><td style="display: none">-</td><td><b>ContentType</b></td><td><b>Url</b></td><td><b>Size</b></td><td><b>Title</b></td><td><b>Creation</b></td></tr><tr><td style="display: none">*</td><td>application/zip</td><td><a href="https://api.synthpharma.example/binaries/nda-12345/m3/stability-package.zip">https://api.synthpharma.example/binaries/nda-12345/m3/stability-package.zip</a></td><td>64424509440</td><td>Stability Data Package (60GB Referenced)</td><td>2025-12-15 10:00:00+0000</td></tr></table></blockquote></blockquote><hr/><blockquote><p class="res-header-id"><b>Generated Narrative: DocumentReference #docref-m5-clinical-study</b></p><a name="task-nda-submission-index-2025/docref-m5-clinical-study"> </a><a name="hctask-nda-submission-index-2025/docref-m5-clinical-study"> </a><p><b>version</b>: 1.0</p><p><b>status</b>: Current</p><p><b>docStatus</b>: Final</p><p><b>type</b>: <span title="Codes:{http://hl7.org/fhir/uv/apix/CodeSystem/ctd-section 5.3.5}">Reports of Efficacy and Safety Studies</span></p><p><b>category</b>: <span title="Codes:{http://hl7.org/fhir/uv/apix/CodeSystem/ctd-module m5}">Module 5</span></p><blockquote><p><b>content</b></p><h3>Attachments</h3><table class="grid"><tr><td style="display: none">-</td><td><b>ContentType</b></td><td><b>Url</b></td><td><b>Size</b></td><td><b>Title</b></td><td><b>Creation</b></td></tr><tr><td style="display: none">*</td><td>application/pdf</td><td><a href="https://api.synthpharma.example/binaries/nda-12345/m5/study-report-001.pdf">https://api.synthpharma.example/binaries/nda-12345/m5/study-report-001.pdf</a></td><td>45000000</td><td>Clinical Study Report - Phase III.pdf</td><td>2025-12-18 09:00:00+0000</td></tr></table></blockquote></blockquote></div>
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<name value="SynthPharma AG"/>
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<contained>
<Organization>
<id value="org-ema"/>
<name value="European Medicines Agency"/>
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<display value="Module 1"/>
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<attachment>
<contentType value="application/pdf"/>
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value="https://api.synthpharma.example/binaries/nda-12345/m1/cover-letter.pdf"/>
<size value="1250000"/>
<title value="Cover Letter.pdf"/>
<creation value="2025-12-20T14:00:00Z"/>
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<display value="Stability"/>
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<code value="m3"/>
<display value="Module 3"/>
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<content>
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<contentType value="application/zip"/>
<url
value="https://api.synthpharma.example/binaries/nda-12345/m3/stability-package.zip"/>
<size value="64424509440"/>
<title value="Stability Data Package (60GB Referenced)"/>
<creation value="2025-12-15T10:00:00Z"/>
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<code value="5.3.5"/>
<display value="Reports of Efficacy and Safety Studies"/>
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<title value="Clinical Study Report - Phase III.pdf"/>
<creation value="2025-12-18T09:00:00Z"/>
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<use value="official"/>
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<code value="task-instance-uuid"/>
<display value="Task Instance UUID"/>
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<system value="urn:ietf:rfc:3986"/>
<value value="urn:uuid:8e4d2a-8b1c-4d9f-9a2e-nda-example"/>
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<status value="requested"/>
<intent value="order"/>
<priority value="routine"/>
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<system value="http://hl7.org/fhir/uv/apix/CodeSystem/apix-task-type"/>
<code value="new-drug-application"/>
<display value="New Drug Application (NDA)"/>
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<authoredOn value="2025-12-20T14:15:00Z"/>
<lastModified value="2025-12-20T14:15:00Z"/>
<requester>
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<owner>
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<code value="regulatory-document"/>
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<code value="regulatory-document"/>
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<reference value="#docref-m3-stability-data"/>
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<code value="regulatory-document"/>
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<valueReference>
<reference value="#docref-m5-clinical-study"/>
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