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

: scenario1-06-technical-response - 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 "scenario1-06-technical-response"] ; # 
  fhir:meta [
fhir:versionId [ fhir:v "1" ] ;
fhir:lastUpdated [ fhir:v "2025-03-15T10:00:00+01:00"^^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\">Response to Questions: Submission of additional stability data</div>"^^rdf:XMLLiteral ]
  ] ; # 
  fhir:contained ( [
a fhir:Organization ;
fhir:id [ fhir:v "org-synthpharma-ag" ] ;
fhir:name [ fhir:v "SynthPharma AG" ] ;
    ( fhir:contact [
      ( fhir:name [
fhir:text [ fhir:v "Dr. John Doe, Head of Regulatory Affairs" ]       ] ) ;
      ( fhir:telecom [
fhir:system [ fhir:v "email" ] ;
fhir:value [ fhir:v "john.doe@synthpharma.example" ] ;
fhir:use [ fhir:v "work" ]       ] )     ] )
  ] [
a fhir:Organization ;
fhir:id [ fhir:v "org-ema-srm-hmed" ] ;
fhir:name [ fhir:v "European Medicines Agency – Human Medicines Evaluation Division" ] ;
    ( fhir:contact [
      ( fhir:name [
fhir:text [ fhir:v "Scientific and Regulatory Management" ]       ] ) ;
      ( fhir:telecom [
fhir:system [ fhir:v "email" ] ;
fhir:value [ fhir:v "srm@ema.example.eu" ] ;
fhir:use [ fhir:v "work" ]       ] )     ] )
  ] [
a fhir:DocumentReference ;
fhir:id [ fhir:v "docref-responses-qresponse" ] ;
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 / Response" ]       ] )     ] ;
fhir:date [ fhir:v "2025-03-15T10:00:00+01:00"^^xsd:dateTime ] ;
    ( fhir:relatesTo [
fhir:target [
fhir:l fhir:DocumentReference/docref-list-of-questions ;
fhir:reference [ fhir:v "DocumentReference/docref-list-of-questions" ] ;
fhir:display [ fhir:v "List of Questions (LoQ)" ]       ]     ] ) ;
    ( fhir:content [
fhir:attachment [
fhir:contentType [ fhir:v "application/fhir+json" ] ;
fhir:url [
fhir:v "https://api.synthpharma.example/questionnaire-responses/qr123.json"^^xsd:anyURI ;
fhir:l <https://api.synthpharma.example/questionnaire-responses/qr123.json>         ] ;
fhir:size [ fhir:v "18400"^^xsd:long ] ;
fhir:title [ fhir:v "Response to Questions (QuestionnaireResponse)" ] ;
fhir:creation [ fhir:v "2025-03-15T09:45:00+01:00"^^xsd:dateTime ]       ]     ] )
  ] [
a fhir:DocumentReference ;
fhir:id [ fhir:v "docref-stability-data-annex" ] ;
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.8.3" ] ;
fhir:display [ fhir:v "Stability Data" ]       ] )     ] ;
fhir:date [ fhir:v "2025-03-15T10:00:00+01:00"^^xsd:dateTime ] ;
    ( fhir:content [
fhir:attachment [
fhir:contentType [ fhir:v "application/fhir+json" ] ;
fhir:url [
fhir:v "https://api.synthpharma.example/bundles/submission-123/m3/stability-data-v2.json"^^xsd:anyURI ;
fhir:l <https://api.synthpharma.example/bundles/submission-123/m3/stability-data-v2.json>         ] ;
fhir:size [ fhir:v "5800000"^^xsd:long ] ;
fhir:title [ fhir:v "Updated Stability Data (Transaction Bundle)" ] ;
fhir:creation [ fhir:v "2025-03-14T11:00:00+01:00"^^xsd:dateTime ]       ]     ] )
  ] ) ; # 
  fhir:identifier ( [
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:888e7d2a-8b1c-4d9f-9a2e-1f6c9d8e7b3c" ]
  ] ) ; # 
  fhir:groupIdentifier [
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 "submission-group-uuid" ] ;
fhir:display [ fhir:v "Submission Group UUID" ]       ] )     ] ;
fhir:system [
fhir:v "urn:ietf:rfc:3986"^^xsd:anyURI ;
fhir:l <urn:ietf:rfc:3986>     ] ;
fhir:value [ fhir:v "urn:uuid:workflow-group-id-12345" ]
  ] ; # 
  fhir:partOf ( [
fhir:l fhir:Task/scenario1-05-technical-question ;
fhir:reference [ fhir:v "Task/scenario1-05-technical-question" ] ;
fhir:display [ fhir:v "Technical Question Task" ]
  ] ) ; # 
  fhir:status [ fhir:v "in-progress"] ; # 
  fhir:businessStatus [
    ( fhir:coding [
fhir:system [
fhir:v "http://hl7.org/fhir/uv/apix/CodeSystem/apix-business-status"^^xsd:anyURI ;
fhir:l <http://hl7.org/fhir/uv/apix/CodeSystem/apix-business-status>       ] ;
fhir:code [ fhir:v "submitted" ] ;
fhir:display [ fhir:v "Submitted" ]     ] )
  ] ; # 
  fhir:intent [ fhir:v "proposal"] ; # 
  fhir:priority [ fhir:v "routine"] ; # 
  fhir:code [
    ( fhir:coding [
fhir:system [
fhir:v "http://hl7.org/fhir/uv/apix/CodeSystem/apix-task-code"^^xsd:anyURI ;
fhir:l <http://hl7.org/fhir/uv/apix/CodeSystem/apix-task-code>       ] ;
fhir:code [ fhir:v "response-to-questions" ] ;
fhir:display [ fhir:v "Response to Information Request" ]     ] )
  ] ; # 
  fhir:for [
fhir:l fhir:MedicinalProductDefinition/example-ma ;
fhir:reference [ fhir:v "MedicinalProductDefinition/example-ma" ] ;
fhir:display [ fhir:v "WonderDrug 50mg Tablets" ]
  ] ; # 
  fhir:authoredOn [ fhir:v "2025-03-15T10:00:00+01:00"^^xsd:dateTime] ; # 
  fhir:lastModified [ fhir:v "2025-03-15T10:00:00+01:00"^^xsd:dateTime] ; # 
  fhir:requester [
fhir:l <#org-synthpharma-ag> ;
fhir:reference [ fhir:v "#org-synthpharma-ag" ] ;
fhir:display [ fhir:v "SynthPharma AG" ]
  ] ; # 
  fhir:requestedPerformer ( [
fhir:reference [
fhir:l <#org-ema-srm-hmed> ;
fhir:reference [ fhir:v "#org-ema-srm-hmed" ] ;
fhir:display [ fhir:v "European Medicines Agency" ]     ]
  ] ) ; # 
  fhir:output ( [
fhir:type [
      ( fhir:coding [
fhir:system [
fhir:v "http://hl7.org/fhir/uv/apix/CodeSystem/apix-task-output-type"^^xsd:anyURI ;
fhir:l <http://hl7.org/fhir/uv/apix/CodeSystem/apix-task-output-type>         ] ;
fhir:code [ fhir:v "regulatory-document" ] ;
fhir:display [ fhir:v "Regulatory Document" ]       ] )     ] ;
fhir:value [
a fhir:Reference ;
fhir:l <#docref-responses-qresponse> ;
fhir:reference [ fhir:v "#docref-responses-qresponse" ] ;
fhir:display [ fhir:v "Applicant QuestionnaireResponse" ]     ]
  ] [
fhir:type [
      ( fhir:coding [
fhir:system [
fhir:v "http://hl7.org/fhir/uv/apix/CodeSystem/apix-task-output-type"^^xsd:anyURI ;
fhir:l <http://hl7.org/fhir/uv/apix/CodeSystem/apix-task-output-type>         ] ;
fhir:code [ fhir:v "regulatory-document" ] ;
fhir:display [ fhir:v "Regulatory Document" ]       ] )     ] ;
fhir:value [
a fhir:Reference ;
fhir:l <#docref-stability-data-annex> ;
fhir:reference [ fhir:v "#docref-stability-data-annex" ] ;
fhir:display [ fhir:v "Annex: Updated Stability Data" ]     ]
  ] ) . #