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

: Initial ICSR — case CH-SYNTHPHARMA-2026-000456

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/DocumentReference/docref-icsr-initial> a fhir:DocumentReference ;
  fhir:nodeRole fhir:treeRoot ;
  fhir:id [ fhir:v "docref-icsr-initial"] ; # 
  fhir:meta [
     fhir:profile ( [
       fhir:v "http://hl7.org/fhir/uv/apix/StructureDefinition/apix-documentreference"^^xsd:anyURI ;
       fhir:link <http://hl7.org/fhir/uv/apix/StructureDefinition/apix-documentreference>
     ] )
  ] ; # 
  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 class=\"res-header-id\"><b>Generated Narrative: DocumentReference docref-icsr-initial</b></p><a name=\"docref-icsr-initial\"> </a><a name=\"hcdocref-icsr-initial\"> </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\"/><p style=\"margin-bottom: 0px\">Profile: <a href=\"StructureDefinition-apix-documentreference.html\">APIX Regulatory DocumentReference</a></p></div><p><b>identifier</b>: Document Set Identifier/urn:uuid:2460574f-c235-510e-bc4c-96e063c30df2, Document Version Number Identifier/urn:uuid:c79a91e1-9537-5933-82dd-7ccf8e9e4eb0</p><p><b>version</b>: 1</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/apix-task-input-output-type icsr-message}\">ICSR Message</span></p><p><b>date</b>: 2026-10-02 09:30:00+0200</p><p><b>author</b>: <a href=\"Organization-org-synthpharma-ag.html\">SynthPharma AG</a></p><p><b>description</b>: </p><div><p>Initial ICH E2B(R3) ICSR for case CH-SYNTHPHARMA-2026-000456 (nausea with WonderDrug 50 mg).</p>\n</div><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>Hash</b></td><td><b>Title</b></td><td><b>Creation</b></td></tr><tr><td style=\"display: none\">*</td><td>application/xml</td><td><a href=\"Binary-binary-icsr-initial.html\">Binary: application/xml (10720 bytes base64)</a></td><td>8038</td><td><code>S+dAYt27+1cEPbqbQxUmGUOT98o=</code></td><td>icsr-initial.xml</td><td>2026-10-02 09:30:00+0200</td></tr></table></blockquote></div>"^^rdf:XMLLiteral ]
  ] ; # 
  fhir:identifier ( [
     fhir:type [
       fhir:coding ( [
         fhir:system [ fhir:v "http://hl7.org/fhir/uv/apix/CodeSystem/apix-demo"^^xsd:anyURI ] ;
         fhir:code [ fhir:v "docsetid" ] ;
         fhir:display [ fhir:v "Document Set Identifier" ]
       ] )
     ] ;
     fhir:system [ fhir:v "http://example.org/synthpharma/document-set-id"^^xsd:anyURI ] ;
     fhir:value [ fhir:v "urn:uuid:2460574f-c235-510e-bc4c-96e063c30df2" ]
  ] [
     fhir:type [
       fhir:coding ( [
         fhir:system [ fhir:v "http://hl7.org/fhir/uv/apix/CodeSystem/apix-demo"^^xsd:anyURI ] ;
         fhir:code [ fhir:v "docverid" ] ;
         fhir:display [ fhir:v "Document Version Number Identifier" ]
       ] )
     ] ;
     fhir:system [ fhir:v "http://example.org/synthpharma/document-version-id"^^xsd:anyURI ] ;
     fhir:value [ fhir:v "urn:uuid:c79a91e1-9537-5933-82dd-7ccf8e9e4eb0" ]
  ] ) ; # 
  fhir:version [ fhir:v "1"] ; # 
  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/apix-task-input-output-type"^^xsd:anyURI ] ;
       fhir:code [ fhir:v "icsr-message" ] ;
       fhir:display [ fhir:v "ICSR Message" ]
     ] )
  ] ; # 
  fhir:date [ fhir:v "2026-10-02T09:30:00+02:00"^^xsd:dateTime] ; # 
  fhir:author ( [
     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:description [ fhir:v "Initial ICH E2B(R3) ICSR for case CH-SYNTHPHARMA-2026-000456 (nausea with WonderDrug 50 mg)."] ; # 
  fhir:content ( [
     fhir:attachment [
       fhir:contentType [ fhir:v "application/xml" ] ;
       fhir:url [ fhir:v "Binary/binary-icsr-initial"^^xsd:anyURI ] ;
       fhir:size [ fhir:v "8038"^^xsd:long ] ;
       fhir:hash [ fhir:v "S+dAYt27+1cEPbqbQxUmGUOT98o="^^xsd:base64Binary ] ;
       fhir:title [ fhir:v "icsr-initial.xml" ] ;
       fhir:creation [ fhir:v "2026-10-02T09:30:00+02:00"^^xsd:dateTime ]
     ]
  ] ) . # 

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