scenario1-01-initial-submission - TTL Representation - API for the Exchange of Medicinal Product Information (APIX) v0.1.0

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
: scenario1-01-initial-submission - TTL Representation

Raw ttl | Download

@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 "scenario1-01-initial-submission"] ; # 
  fhir:meta [
fhir:versionId [ fhir:v "1" ] ;
fhir:lastUpdated [ fhir:v "2025-11-15T09:00:00+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\">Task: Initial Submission of Type IB Variation (Shelf-Life)</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 "doc1" ] ;
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 "cover-letter" ] ;
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/submission-123/m1/cover-letter.pdf"^^xsd:anyURI ;
fhir:l <https://api.synthpharma.example/binaries/submission-123/m1/cover-letter.pdf>         ] ;
fhir:size [ fhir:v "1250000"^^xsd:long ] ;
fhir:title [ fhir:v "Cover Letter.pdf" ] ;
fhir:creation [ fhir:v "2025-11-15T08:30:00+01:00"^^xsd:dateTime ]       ]     ] )
  ] [
a fhir:DocumentReference ;
fhir:id [ fhir:v "doc2" ] ;
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 "application-form" ] ;
fhir:display [ fhir:v "Application Form" ]       ] )     ] ;
    ( 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/submission-123/m1/app-form.pdf"^^xsd:anyURI ;
fhir:l <https://api.synthpharma.example/binaries/submission-123/m1/app-form.pdf>         ] ;
fhir:size [ fhir:v "3400000"^^xsd:long ] ;
fhir:title [ fhir:v "Application Form.pdf" ] ;
fhir:creation [ fhir:v "2025-11-15T08:35:00+01:00"^^xsd:dateTime ]       ]     ] )
  ] [
a fhir:DocumentReference ;
fhir:id [ fhir:v "doc3" ] ;
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 "annotated-label" ] ;
fhir:display [ fhir:v "Annotated Label" ]       ] )     ] ;
    ( 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/fhir+json" ] ;
fhir:url [
fhir:v "https://api.synthpharma.example/bundles/submission-123/m1/annotated-label.json"^^xsd:anyURI ;
fhir:l <https://api.synthpharma.example/bundles/submission-123/m1/annotated-label.json>         ] ;
fhir:size [ fhir:v "45000"^^xsd:long ] ;
fhir:title [ fhir:v "Annotated Label (Bundle)" ] ;
fhir:creation [ fhir:v "2025-11-14T16:00:00+01:00"^^xsd:dateTime ]       ]     ] )
  ] [
a fhir:DocumentReference ;
fhir:id [ fhir:v "doc4" ] ;
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 "clean-label" ] ;
fhir:display [ fhir:v "Clean Label" ]       ] )     ] ;
    ( 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/fhir+json" ] ;
fhir:url [
fhir:v "https://api.synthpharma.example/bundles/submission-123/m1/clean-label.json"^^xsd:anyURI ;
fhir:l <https://api.synthpharma.example/bundles/submission-123/m1/clean-label.json>         ] ;
fhir:size [ fhir:v "42000"^^xsd:long ] ;
fhir:title [ fhir:v "Clean Label (Bundle)" ] ;
fhir:creation [ fhir:v "2025-11-14T16:05:00+01:00"^^xsd:dateTime ]       ]     ] )
  ] [
a fhir:DocumentReference ;
fhir:id [ fhir:v "doc5" ] ;
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 "pack-mockup" ] ;
fhir:display [ fhir:v "Pack Mockup" ]       ] )     ] ;
    ( fhir:content [
fhir:attachment [
fhir:contentType [ fhir:v "text/html" ] ;
fhir:url [
fhir:v "https://api.synthpharma.example/binaries/submission-123/m1/mockup.html"^^xsd:anyURI ;
fhir:l <https://api.synthpharma.example/binaries/submission-123/m1/mockup.html>         ] ;
fhir:size [ fhir:v "890000"^^xsd:long ] ;
fhir:title [ fhir:v "Pack Mockup.html" ] ;
fhir:creation [ fhir:v "2025-11-14T10:00:00+01:00"^^xsd:dateTime ]       ]     ] )
  ] [
a fhir:DocumentReference ;
fhir:id [ fhir:v "doc6" ] ;
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 "cmc-stability-summary" ] ;
fhir:display [ fhir:v "Stability Summary" ]       ] )     ] ;
    ( 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/fhir+json" ] ;
fhir:url [
fhir:v "https://api.synthpharma.example/bundles/submission-123/m3/stability-summary.json"^^xsd:anyURI ;
fhir:l <https://api.synthpharma.example/bundles/submission-123/m3/stability-summary.json>         ] ;
fhir:size [ fhir:v "156000"^^xsd:long ] ;
fhir:title [ fhir:v "CMC Doc 1 - Summary (Transaction Bundle)" ] ;
fhir:creation [ fhir:v "2025-11-12T14:30:00+01:00"^^xsd:dateTime ]       ]     ] )
  ] [
a fhir:DocumentReference ;
fhir:id [ fhir:v "doc7" ] ;
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 "cmc-stability-data" ] ;
fhir:display [ fhir:v "Stability Data" ]       ] )     ] ;
    ( 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/fhir+json" ] ;
fhir:url [
fhir:v "https://api.synthpharma.example/bundles/submission-123/m3/stability-data.json"^^xsd:anyURI ;
fhir:l <https://api.synthpharma.example/bundles/submission-123/m3/stability-data.json>         ] ;
fhir:size [ fhir:v "5600000"^^xsd:long ] ;
fhir:title [ fhir:v "CMC Doc 2 - Data (Transaction Bundle)" ] ;
fhir:creation [ fhir:v "2025-11-12T14:35:00+01:00"^^xsd:dateTime ]       ]     ] )
  ] [
a fhir:DocumentReference ;
fhir:id [ fhir:v "doc8" ] ;
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 "cmc-stability-commitment" ] ;
fhir:display [ fhir:v "Stability Commitment" ]       ] )     ] ;
    ( 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/fhir+json" ] ;
fhir:url [
fhir:v "https://api.synthpharma.example/bundles/submission-123/m3/stability-commitment.json"^^xsd:anyURI ;
fhir:l <https://api.synthpharma.example/bundles/submission-123/m3/stability-commitment.json>         ] ;
fhir:size [ fhir:v "24000"^^xsd:long ] ;
fhir:title [ fhir:v "CMC Doc 3 - Commitment (Transaction Bundle)" ] ;
fhir:creation [ fhir:v "2025-11-12T14:40:00+01:00"^^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:workflow-step1-instance" ]
  ] ) ; # 
  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:status [ fhir:v "requested"] ; # 
  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 "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 "variation-type-ib" ] ;
fhir:display [ fhir:v "Type IB Variation" ]     ] )
  ] ; # 
  fhir:authoredOn [ fhir:v "2025-11-15T09:00:00+01:00"^^xsd:dateTime] ; # 
  fhir:lastModified [ fhir:v "2025-11-15T09:00:00+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: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:display [ fhir:v "Regulatory Document" ]       ] )     ] ;
fhir:value [
a fhir:Reference ;
fhir:l <#doc1> ;
fhir:reference [ fhir:v "#doc1" ]     ]
  ] [
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:display [ fhir:v "Regulatory Document" ]       ] )     ] ;
fhir:value [
a fhir:Reference ;
fhir:l <#doc2> ;
fhir:reference [ fhir:v "#doc2" ]     ]
  ] [
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:display [ fhir:v "Regulatory Document" ]       ] )     ] ;
fhir:value [
a fhir:Reference ;
fhir:l <#doc3> ;
fhir:reference [ fhir:v "#doc3" ]     ]
  ] [
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:display [ fhir:v "Regulatory Document" ]       ] )     ] ;
fhir:value [
a fhir:Reference ;
fhir:l <#doc4> ;
fhir:reference [ fhir:v "#doc4" ]     ]
  ] [
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:display [ fhir:v "Regulatory Document" ]       ] )     ] ;
fhir:value [
a fhir:Reference ;
fhir:l <#doc5> ;
fhir:reference [ fhir:v "#doc5" ]     ]
  ] [
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:display [ fhir:v "Regulatory Document" ]       ] )     ] ;
fhir:value [
a fhir:Reference ;
fhir:l <#doc6> ;
fhir:reference [ fhir:v "#doc6" ]     ]
  ] [
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:display [ fhir:v "Regulatory Document" ]       ] )     ] ;
fhir:value [
a fhir:Reference ;
fhir:l <#doc7> ;
fhir:reference [ fhir:v "#doc7" ]     ]
  ] [
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:display [ fhir:v "Regulatory Document" ]       ] )     ] ;
fhir:value [
a fhir:Reference ;
fhir:l <#doc8> ;
fhir:reference [ fhir:v "#doc8" ]     ]
  ] ) . #