task-shelf-life-extension-synthpharma-2025 - 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
: task-shelf-life-extension-synthpharma-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-shelf-life-extension-synthpharma-2025"] ; # 
  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\">Type IB Variation (C.I.4) – Extension of shelf-life for the finished product SynthVac 50 mg film-coated tablets from 24 months to 36 months based on additional long-term stability data at 25°C/60% RH.</div>"^^rdf:XMLLiteral ]
  ] ; # 
  fhir:contained ( [
a fhir:Organization ;
fhir:id [ fhir:v "org-synthpharma-ag" ] ;
    ( fhir:identifier [
fhir:system [
fhir:v "https://spor.ema.europa.eu/v1/organisations"^^xsd:anyURI ;
fhir:l <https://spor.ema.europa.eu/v1/organisations>       ] ;
fhir:value [ fhir:v "ORG-987654" ]     ] ) ;
fhir:name [ fhir:v "SynthPharma AG" ] ;
    ( fhir:contact [
      ( fhir:name [
fhir:text [ fhir:v "Dr. John Doe, Head of Regulatory Affairs, Global Regulatory Strategy" ]       ] ) ;
      ( 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:identifier [
fhir:system [
fhir:v "https://spor.ema.europa.eu/v1/organisations"^^xsd:anyURI ;
fhir:l <https://spor.ema.europa.eu/v1/organisations>       ] ;
fhir:value [ fhir:v "ORG-EMA-000001" ]     ] ) ;
fhir:name [ fhir:v "European Medicines Agency – Human Medicines Evaluation Division – Scientific and Regulatory Management" ] ;
    ( fhir:contact [
      ( fhir:name [
fhir:text [ fhir:v "Dr. Jane Doe, Scientific Officer" ]       ] ) ;
      ( fhir:telecom [
fhir:system [ fhir:v "phone" ] ;
fhir:value [ fhir:v "+31-88-781-6000" ] ;
fhir:use [ fhir:v "work" ]       ] [
fhir:system [ fhir:v "email" ] ;
fhir:value [ fhir:v "jane.doe@example.eu" ] ;
fhir:use [ fhir:v "work" ]       ] )     ] )
  ] [
a fhir:DocumentReference ;
fhir:id [ fhir:v "docref-cover-letter" ] ;
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-documentreference"^^xsd:anyURI ;
fhir:l <http://hl7.org/fhir/uv/apix/StructureDefinition/apix-documentreference>       ] )     ] ;
fhir:status [ fhir:v "current" ] ;
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:date [ fhir:v "2025-11-15T09:00:00+01:00"^^xsd:dateTime ] ;
    ( fhir:content [
fhir:attachment [
fhir:contentType [ fhir:v "application/fhir+json" ] ;
fhir:data [ fhir:v "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"^^xsd:base64Binary ] ;
fhir:title [ fhir:v "Cover_Letter_SynthVac_ShelfLife_Extension_2025.json" ] ;
fhir:creation [ fhir:v "2025-11-15T09:00:00+01:00"^^xsd:dateTime ]       ]     ] )
  ] [
a fhir:DocumentReference ;
fhir:id [ fhir:v "docref-labeling" ] ;
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-documentreference"^^xsd:anyURI ;
fhir:l <http://hl7.org/fhir/uv/apix/StructureDefinition/apix-documentreference>       ] )     ] ;
fhir:status [ fhir:v "current" ] ;
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 "1.3.1" ] ;
fhir:display [ fhir:v "SPC, Labelling and Package Leaflet" ]       ] )     ] ;
fhir:date [ fhir:v "2025-11-15T09:00:00+01:00"^^xsd:dateTime ] ;
    ( fhir:content [
fhir:attachment [
fhir:contentType [ fhir:v "application/fhir+json" ] ;
fhir:data [ fhir:v "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"^^xsd:base64Binary ] ;
fhir:title [ fhir:v "SynthVac_Annotated_SmPC_PIL_36months.json" ] ;
fhir:creation [ fhir:v "2025-11-15T09:00:00+01:00"^^xsd:dateTime ]       ]     ] )
  ] [
a fhir:DocumentReference ;
fhir:id [ fhir:v "docref-quality" ] ;
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-documentreference"^^xsd:anyURI ;
fhir:l <http://hl7.org/fhir/uv/apix/StructureDefinition/apix-documentreference>       ] )     ] ;
fhir:status [ fhir:v "current" ] ;
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 "2.3" ] ;
fhir:display [ fhir:v "Quality Overall Summary" ]       ] )     ] ;
fhir:date [ fhir:v "2025-11-15T09:00:00+01:00"^^xsd:dateTime ] ;
    ( fhir:content [
fhir:attachment [
fhir:contentType [ fhir:v "application/fhir+json" ] ;
fhir:data [ fhir:v "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"^^xsd:base64Binary ] ;
fhir:title [ fhir:v "3.2.S.7_Stability_Summary_and_Conclusions.json" ] ;
fhir:creation [ fhir:v "2025-11-15T09:00:00+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:5f3e7d2a-8b1c-4d9f-9a2e-1f6c9d8e7b3a" ]
  ] [
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 "regulator-procedure-number" ] ;
fhir:display [ fhir:v "Regulator Procedure Number" ]       ] )     ] ;
fhir:system [
fhir:v "https://ema.europa.eu/fhir/identifier/procedure"^^xsd:anyURI ;
fhir:l <https://ema.europa.eu/fhir/identifier/procedure>     ] ;
fhir:value [ fhir:v "EU/1/23/4567/001-IB/023" ]
  ] ) ; # 
  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:a1b2c3d4-e5f6-7890-g1h2-i3j4k5l6m7n8" ]
  ] ; # 
  fhir:status [ fhir:v "requested"] ; # 
  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-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:requestedPerformer ( [
fhir:reference [
fhir:l fhir:Organization/org-mah-98765 ;
fhir:reference [ fhir:v "Organization/org-mah-98765" ] ;
fhir:display [ fhir:v "PharmaCorp International Ltd" ]     ]
  ] ) ; # 
  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-cover-letter> ;
fhir:reference [ fhir:v "#docref-cover-letter" ] ;
fhir:display [ fhir:v "Cover Letter" ]     ]
  ] [
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-labeling> ;
fhir:reference [ fhir:v "#docref-labeling" ] ;
fhir:display [ fhir:v "Annotated Labeling" ]     ]
  ] [
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-quality> ;
fhir:reference [ fhir:v "#docref-quality" ] ;
fhir:display [ fhir:v "Quality Overall Summary" ]     ]
  ] ) . #