Regulatory Workflows and Interactions - pharma
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Regulatory Workflows and Interactions - pharma, published by HL7 International / Biomedical Research and Regulation. 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

: scenario2 02 initial ICSR acknowledged

Page standards status: Informative

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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 -------------------------------------------------------------------

<http://hl7.org/fhir/Task/scenario2-02-icsr-initial-acknowledged> a fhir:Task ;
  fhir:nodeRole fhir:treeRoot ;
  fhir:id [ fhir:v "scenario2-02-icsr-initial-acknowledged"] ; # 
  fhir:meta [
     fhir:versionId [ fhir:v "2" ] ;
     fhir:lastUpdated [ fhir:v "2026-10-02T09:45:12+02:00"^^xsd:dateTime ] ;
     fhir:profile ( [
       fhir:v "http://hl7.org/fhir/uv/apix/StructureDefinition/apix-task"^^xsd:anyURI ;
       fhir:link <http://hl7.org/fhir/uv/apix/StructureDefinition/apix-task>
     ] )
  ] ; # 
  fhir:language [ fhir:v "en"] ; # 
  fhir:text [
     fhir:status [ fhir:v "generated" ] ;
     fhir:div [ fhir:v "<div xmlns=\"http://www.w3.org/1999/xhtml\"><p><b>Initial ICSR acknowledged (AA / CA)</b></p><table class=\"grid\"><tr><th>Task</th><td>Initial ICSR (<code>icsr-initial</code>)</td></tr><tr><th>Version</th><td>2</td></tr><tr><th>Status</th><td>completed</td></tr><tr><th>Business status</th><td>Report Accepted (CA) (<code>icsr-accepted</code>)</td></tr><tr><th>Requester</th><td>SynthPharma AG</td></tr><tr><th>Owner</th><td>Health Authority – Regulatory Review Division</td></tr><tr><th>Group identifier</th><td>urn:uuid:2b79691d-57aa-5afa-b857-b0fa634df1bd</td></tr><tr><th>Authored</th><td>2026-10-02T09:30:00+02:00</td></tr><tr><th>Last modified</th><td>2026-10-02T09:45:12+02:00</td></tr></table><p><b>Inputs (from the requester)</b></p><ul><li><a href=\"DocumentReference-docref-icsr-initial.html\">Initial ICSR</a> <code>icsr-message</code></li></ul><p><b>Outputs (from the owner)</b></p><ul><li><a href=\"DocumentReference-docref-icsr-initial-ack.html\">Acknowledgment of initial ICSR</a> <code>icsr-acknowledgment</code></li></ul></div>"^^rdf:XMLLiteral ]
  ] ; # 
  fhir:identifier ( [
     fhir:use [ fhir:v "official" ] ;
     fhir:type [
       fhir:coding ( [
         fhir:system [ fhir:v "http://hl7.org/fhir/uv/apix/CodeSystem/apix-demo"^^xsd:anyURI ] ;
         fhir:code [ fhir:v "apixtaskinstance" ] ;
         fhir:display [ fhir:v "APIX Task Instance ID" ]
       ] )
     ] ;
     fhir:system [ fhir:v "http://example.org/health-authority/task-id"^^xsd:anyURI ] ;
     fhir:value [ fhir:v "urn:uuid:8b52452c-4933-5c55-874c-51601a112860" ]
  ] ) ; # 
  fhir:groupIdentifier [
     fhir:use [ fhir:v "official" ] ;
     fhir:system [ fhir:v "http://example.org/health-authority/work-flow-group-id"^^xsd:anyURI ] ;
     fhir:value [ fhir:v "urn:uuid:2b79691d-57aa-5afa-b857-b0fa634df1bd" ]
  ] ; # 
  fhir:status [ fhir:v "completed"] ; # 
  fhir:businessStatus [
     fhir:coding ( [
       fhir:system [ fhir:v "http://hl7.org/fhir/uv/apix/CodeSystem/apix-business-status"^^xsd:anyURI ] ;
       fhir:code [ fhir:v "icsr-accepted" ] ;
       fhir:display [ fhir:v "Report Accepted (CA)" ]
     ] )
  ] ; # 
  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:code [ fhir:v "icsr-initial" ] ;
       fhir:display [ fhir:v "Initial ICSR" ]
     ] )
  ] ; # 
  fhir:executionPeriod [
     fhir:start [ fhir:v "2026-10-02T09:30:05+02:00"^^xsd:dateTime ] ;
     fhir:end [ fhir:v "2026-10-02T09:45:12+02:00"^^xsd:dateTime ]
  ] ; # 
  fhir:authoredOn [ fhir:v "2026-10-02T09:30:00+02:00"^^xsd:dateTime] ; # 
  fhir:lastModified [ fhir:v "2026-10-02T09:45:12+02:00"^^xsd:dateTime] ; # 
  fhir:requester [
     fhir:link <http://hl7.org/fhir/Organization/org-synthpharma-ag> ;
     fhir:reference [ fhir:v "Organization/org-synthpharma-ag" ] ;
     fhir:display [ fhir:v "SynthPharma AG" ]
  ] ; # 
  fhir:owner [
     fhir:link <http://hl7.org/fhir/Organization/org-ema-srm-hmed> ;
     fhir:reference [ fhir:v "Organization/org-ema-srm-hmed" ] ;
     fhir:display [ fhir:v "Health Authority – Regulatory Review Division" ]
  ] ; # 
  fhir:input ( [
     fhir:type [
       fhir:coding ( [
         fhir:system [ fhir:v "http://hl7.org/fhir/uv/apix/CodeSystem/apix-task-input-output-type"^^xsd:anyURI ] ;
         fhir:code [ fhir:v "icsr-message" ] ;
         fhir:display [ fhir:v "ICSR Message" ]
       ] )
     ] ;
     fhir:value [
       a fhir:Reference ;
       fhir:link <http://hl7.org/fhir/DocumentReference/docref-icsr-initial> ;
       fhir:reference [ fhir:v "DocumentReference/docref-icsr-initial" ] ;
       fhir:display [ fhir:v "Initial ICSR" ]
     ]
  ] ) ; # 
  fhir:output ( [
     fhir:type [
       fhir:coding ( [
         fhir:system [ fhir:v "http://hl7.org/fhir/uv/apix/CodeSystem/apix-task-input-output-type"^^xsd:anyURI ] ;
         fhir:code [ fhir:v "icsr-acknowledgment" ] ;
         fhir:display [ fhir:v "ICSR Acknowledgment" ]
       ] )
     ] ;
     fhir:value [
       a fhir:Reference ;
       fhir:link <http://hl7.org/fhir/DocumentReference/docref-icsr-initial-ack> ;
       fhir:reference [ fhir:v "DocumentReference/docref-icsr-initial-ack" ] ;
       fhir:display [ fhir:v "Acknowledgment of initial ICSR" ]
     ]
  ] ) . # 

<http://hl7.org/fhir/Organization/org-synthpharma-ag> a fhir:Organization .

<http://hl7.org/fhir/Organization/org-ema-srm-hmed> a fhir:Organization .

<http://hl7.org/fhir/DocumentReference/docref-icsr-initial> a fhir:DocumentReference .

<http://hl7.org/fhir/DocumentReference/docref-icsr-initial-ack> a fhir:DocumentReference .