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

: Example Task - task-nda-submission-index-2025 - TTL Representation

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@prefix fhir: <http://hl7.org/fhir/> .
@prefix owl: <http://www.w3.org/2002/07/owl#> .
@prefix rdf: <http://www.w3.org/1999/02/22-rdf-syntax-ns#> .
@prefix rdfs: <http://www.w3.org/2000/01/rdf-schema#> .
@prefix xsd: <http://www.w3.org/2001/XMLSchema#> .

# - resource -------------------------------------------------------------------

 a fhir:Task ;
  fhir:nodeRole fhir:treeRoot ;
  fhir:id [ fhir:v "task-nda-submission-index-2025"] ; # 
  fhir:meta [
fhir:versionId [ fhir:v "1" ] ;
fhir:lastUpdated [ fhir:v "2025-12-20T14:15:00Z"^^xsd:dateTime ] ;
    ( fhir:profile [
fhir:v "http://hl7.org/fhir/uv/apix/StructureDefinition/apix-task"^^xsd:anyURI ;
fhir:l <http://hl7.org/fhir/uv/apix/StructureDefinition/apix-task>     ] )
  ] ; # 
  fhir:text [
fhir:status [ fhir:v "generated" ] ;
fhir:div [ fhir:v "<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>"^^rdf:XMLLiteral ]
  ] ; # 
  fhir:contained ( [
a fhir:Organization ;
fhir:id [ fhir:v "org-synthpharma-ag" ] ;
fhir:name [ fhir:v "SynthPharma AG" ]
  ] [
a fhir:Organization ;
fhir:id [ fhir:v "org-ema" ] ;
fhir:name [ fhir:v "European Medicines Agency" ]
  ] [
a fhir:DocumentReference ;
fhir:id [ fhir:v "docref-m1-cover" ] ;
fhir:version [ fhir:v "1.0" ] ;
fhir:status [ fhir:v "current" ] ;
fhir:docStatus [ fhir:v "final" ] ;
fhir:type [
      ( fhir:coding [
fhir:system [
fhir:v "http://hl7.org/fhir/uv/apix/CodeSystem/ctd-section"^^xsd:anyURI ;
fhir:l <http://hl7.org/fhir/uv/apix/CodeSystem/ctd-section>         ] ;
fhir:code [ fhir:v "1.0" ] ;
fhir:display [ fhir:v "Cover Letter" ]       ] )     ] ;
    ( fhir:category [
      ( fhir:coding [
fhir:system [
fhir:v "http://hl7.org/fhir/uv/apix/CodeSystem/ctd-module"^^xsd:anyURI ;
fhir:l <http://hl7.org/fhir/uv/apix/CodeSystem/ctd-module>         ] ;
fhir:code [ fhir:v "m1" ] ;
fhir:display [ fhir:v "Module 1" ]       ] )     ] ) ;
    ( fhir:content [
fhir:attachment [
fhir:contentType [ fhir:v "application/pdf" ] ;
fhir:url [
fhir:v "https://api.synthpharma.example/binaries/nda-12345/m1/cover-letter.pdf"^^xsd:anyURI ;
fhir:l <https://api.synthpharma.example/binaries/nda-12345/m1/cover-letter.pdf>         ] ;
fhir:size [ fhir:v "1250000"^^xsd:long ] ;
fhir:title [ fhir:v "Cover Letter.pdf" ] ;
fhir:creation [ fhir:v "2025-12-20T14:00:00Z"^^xsd:dateTime ]       ]     ] )
  ] [
a fhir:DocumentReference ;
fhir:id [ fhir:v "docref-m3-stability-data" ] ;
fhir:version [ fhir:v "1.0" ] ;
fhir:status [ fhir:v "current" ] ;
fhir:docStatus [ fhir:v "final" ] ;
fhir:type [
      ( fhir:coding [
fhir:system [
fhir:v "http://hl7.org/fhir/uv/apix/CodeSystem/ctd-section"^^xsd:anyURI ;
fhir:l <http://hl7.org/fhir/uv/apix/CodeSystem/ctd-section>         ] ;
fhir:code [ fhir:v "3.2.P.8" ] ;
fhir:display [ fhir:v "Stability" ]       ] )     ] ;
    ( fhir:category [
      ( fhir:coding [
fhir:system [
fhir:v "http://hl7.org/fhir/uv/apix/CodeSystem/ctd-module"^^xsd:anyURI ;
fhir:l <http://hl7.org/fhir/uv/apix/CodeSystem/ctd-module>         ] ;
fhir:code [ fhir:v "m3" ] ;
fhir:display [ fhir:v "Module 3" ]       ] )     ] ) ;
    ( fhir:content [
fhir:attachment [
fhir:contentType [ fhir:v "application/zip" ] ;
fhir:url [
fhir:v "https://api.synthpharma.example/binaries/nda-12345/m3/stability-package.zip"^^xsd:anyURI ;
fhir:l <https://api.synthpharma.example/binaries/nda-12345/m3/stability-package.zip>         ] ;
fhir:size [ fhir:v "64424509440"^^xsd:long ] ;
fhir:title [ fhir:v "Stability Data Package (60GB Referenced)" ] ;
fhir:creation [ fhir:v "2025-12-15T10:00:00Z"^^xsd:dateTime ]       ]     ] )
  ] [
a fhir:DocumentReference ;
fhir:id [ fhir:v "docref-m5-clinical-study" ] ;
fhir:version [ fhir:v "1.0" ] ;
fhir:status [ fhir:v "current" ] ;
fhir:docStatus [ fhir:v "final" ] ;
fhir:type [
      ( fhir:coding [
fhir:system [
fhir:v "http://hl7.org/fhir/uv/apix/CodeSystem/ctd-section"^^xsd:anyURI ;
fhir:l <http://hl7.org/fhir/uv/apix/CodeSystem/ctd-section>         ] ;
fhir:code [ fhir:v "5.3.5" ] ;
fhir:display [ fhir:v "Reports of Efficacy and Safety Studies" ]       ] )     ] ;
    ( fhir:category [
      ( fhir:coding [
fhir:system [
fhir:v "http://hl7.org/fhir/uv/apix/CodeSystem/ctd-module"^^xsd:anyURI ;
fhir:l <http://hl7.org/fhir/uv/apix/CodeSystem/ctd-module>         ] ;
fhir:code [ fhir:v "m5" ] ;
fhir:display [ fhir:v "Module 5" ]       ] )     ] ) ;
    ( fhir:content [
fhir:attachment [
fhir:contentType [ fhir:v "application/pdf" ] ;
fhir:url [
fhir:v "https://api.synthpharma.example/binaries/nda-12345/m5/study-report-001.pdf"^^xsd:anyURI ;
fhir:l <https://api.synthpharma.example/binaries/nda-12345/m5/study-report-001.pdf>         ] ;
fhir:size [ fhir:v "45000000"^^xsd:long ] ;
fhir:title [ fhir:v "Clinical Study Report - Phase III.pdf" ] ;
fhir:creation [ fhir:v "2025-12-18T09:00:00Z"^^xsd:dateTime ]       ]     ] )
  ] ) ; # 
  fhir:identifier ( [
fhir:use [ fhir:v "official" ] ;
fhir:type [
      ( fhir:coding [
fhir:system [
fhir:v "http://hl7.org/fhir/uv/apix/CodeSystem/apix-identifier-type"^^xsd:anyURI ;
fhir:l <http://hl7.org/fhir/uv/apix/CodeSystem/apix-identifier-type>         ] ;
fhir:code [ fhir:v "task-instance-uuid" ] ;
fhir:display [ fhir:v "Task Instance UUID" ]       ] )     ] ;
fhir:system [
fhir:v "urn:ietf:rfc:3986"^^xsd:anyURI ;
fhir:l <urn:ietf:rfc:3986>     ] ;
fhir:value [ fhir:v "urn:uuid:8e4d2a-8b1c-4d9f-9a2e-nda-example" ]
  ] ) ; # 
  fhir:status [ fhir:v "requested"] ; # 
  fhir:intent [ fhir:v "order"] ; # 
  fhir:priority [ fhir:v "routine"] ; # 
  fhir:code [
    ( fhir:coding [
fhir:system [
fhir:v "http://hl7.org/fhir/uv/apix/CodeSystem/apix-task-type"^^xsd:anyURI ;
fhir:l <http://hl7.org/fhir/uv/apix/CodeSystem/apix-task-type>       ] ;
fhir:code [ fhir:v "new-drug-application" ] ;
fhir:display [ fhir:v "New Drug Application (NDA)" ]     ] )
  ] ; # 
  fhir:authoredOn [ fhir:v "2025-12-20T14:15:00Z"^^xsd:dateTime] ; # 
  fhir:lastModified [ fhir:v "2025-12-20T14:15:00Z"^^xsd:dateTime] ; # 
  fhir:requester [
fhir:l <#org-synthpharma-ag> ;
fhir:reference [ fhir:v "#org-synthpharma-ag" ]
  ] ; # 
  fhir:owner [
fhir:l <#org-ema> ;
fhir:reference [ fhir:v "#org-ema" ]
  ] ; # 
  fhir:input ( [
fhir:type [
      ( fhir:coding [
fhir:system [
fhir:v "http://hl7.org/fhir/uv/apix/CodeSystem/apix-task-input-type"^^xsd:anyURI ;
fhir:l <http://hl7.org/fhir/uv/apix/CodeSystem/apix-task-input-type>         ] ;
fhir:code [ fhir:v "regulatory-document" ]       ] )     ] ;
fhir:value [
a fhir:Reference ;
fhir:l <#docref-m1-cover> ;
fhir:reference [ fhir:v "#docref-m1-cover" ]     ]
  ] [
fhir:type [
      ( fhir:coding [
fhir:system [
fhir:v "http://hl7.org/fhir/uv/apix/CodeSystem/apix-task-input-type"^^xsd:anyURI ;
fhir:l <http://hl7.org/fhir/uv/apix/CodeSystem/apix-task-input-type>         ] ;
fhir:code [ fhir:v "regulatory-document" ]       ] )     ] ;
fhir:value [
a fhir:Reference ;
fhir:l <#docref-m3-stability-data> ;
fhir:reference [ fhir:v "#docref-m3-stability-data" ]     ]
  ] [
fhir:type [
      ( fhir:coding [
fhir:system [
fhir:v "http://hl7.org/fhir/uv/apix/CodeSystem/apix-task-input-type"^^xsd:anyURI ;
fhir:l <http://hl7.org/fhir/uv/apix/CodeSystem/apix-task-input-type>         ] ;
fhir:code [ fhir:v "regulatory-document" ]       ] )     ] ;
fhir:value [
a fhir:Reference ;
fhir:l <#docref-m5-clinical-study> ;
fhir:reference [ fhir:v "#docref-m5-clinical-study" ]     ]
  ] ) . #