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

: scenario4 02 Type II variation validated

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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/scenario4-02-variation-validated> a fhir:Task ;
  fhir:nodeRole fhir:treeRoot ;
  fhir:id [ fhir:v "scenario4-02-variation-validated"] ; # 
  fhir:meta [
     fhir:versionId [ fhir:v "2" ] ;
     fhir:lastUpdated [ fhir:v "2027-01-15T14:00:00+01:00"^^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>Type II variation validated</b></p><table class=\"grid\"><tr><th>Task</th><td>Type II Variation (<code>variation-type-ii</code>)</td></tr><tr><th>Procedure number</th><td>VAR-II-2027-0012</td></tr><tr><th>Version</th><td>2</td></tr><tr><th>Status</th><td>accepted</td></tr><tr><th>Business status</th><td>Validation Successful (<code>validation-successful</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:60ac55b8-8d46-58ff-b1b2-e8015d4960be</td></tr><tr><th>Authored</th><td>2027-01-11T10:00:00+01:00</td></tr><tr><th>Last modified</th><td>2027-01-15T14:00:00+01:00</td></tr></table><p><b>Inputs (from the requester)</b></p><ul><li><a href=\"DocumentReference-docref-var-cover-letter.html\">Variation cover letter</a> <code>cover-letter</code></li><li><a href=\"DocumentReference-docref-var-application-form.html\">Variation application form</a> <code>application-form</code></li><li><a href=\"DocumentReference-docref-var-change-description.html\">Change description and justification</a> <code>change-description</code></li><li><a href=\"DocumentReference-docref-epi-annotated-v1.html\">Annotated ePI v1 (proposal)</a> <code>proposed-labelling</code></li><li><a href=\"DocumentReference-docref-epi-clean-v1.html\">Clean ePI v1 (proposal)</a> <code>epi-bundle</code></li></ul><p><b>Outputs (from the owner)</b></p><ul><li><a href=\"DocumentReference-docref-var-validation-report.html\">Variation validation report</a> <code>validation-report</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:86c83ea7-80e5-5efa-aa1a-4cd36f9a425e" ]
  ] [
     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 "apixregulatorprocedureno" ] ;
         fhir:display [ fhir:v "APIX Regulator Procedure Number" ]
       ] )
     ] ;
     fhir:system [ fhir:v "http://example.org/health-authority/procedure-number"^^xsd:anyURI ] ;
     fhir:value [ fhir:v "VAR-II-2027-0012" ]
  ] ) ; # 
  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:60ac55b8-8d46-58ff-b1b2-e8015d4960be" ]
  ] ; # 
  fhir:status [ fhir:v "accepted"] ; # 
  fhir:businessStatus [
     fhir:coding ( [
       fhir:system [ fhir:v "http://hl7.org/fhir/uv/apix/CodeSystem/apix-business-status"^^xsd:anyURI ] ;
       fhir:code [ fhir:v "validation-successful" ] ;
       fhir:display [ fhir:v "Validation Successful" ]
     ] )
  ] ; # 
  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 "variation-type-ii" ] ;
       fhir:display [ fhir:v "Type II Variation" ]
     ] )
  ] ; # 
  fhir:executionPeriod [
     fhir:start [ fhir:v "2027-01-15T14:00:00+01:00"^^xsd:dateTime ]
  ] ; # 
  fhir:authoredOn [ fhir:v "2027-01-11T10:00:00+01:00"^^xsd:dateTime] ; # 
  fhir:lastModified [ fhir:v "2027-01-15T14:00:00+01:00"^^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 "cover-letter" ] ;
         fhir:display [ fhir:v "Cover Letter" ]
       ] )
     ] ;
     fhir:value [
       a fhir:Reference ;
       fhir:link <http://hl7.org/fhir/DocumentReference/docref-var-cover-letter> ;
       fhir:reference [ fhir:v "DocumentReference/docref-var-cover-letter" ] ;
       fhir:display [ fhir:v "Variation cover letter" ]
     ]
  ] [
     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 "application-form" ] ;
         fhir:display [ fhir:v "Application Form" ]
       ] )
     ] ;
     fhir:value [
       a fhir:Reference ;
       fhir:link <http://hl7.org/fhir/DocumentReference/docref-var-application-form> ;
       fhir:reference [ fhir:v "DocumentReference/docref-var-application-form" ] ;
       fhir:display [ fhir:v "Variation application form" ]
     ]
  ] [
     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 "change-description" ] ;
         fhir:display [ fhir:v "Change Description and Justification" ]
       ] )
     ] ;
     fhir:value [
       a fhir:Reference ;
       fhir:link <http://hl7.org/fhir/DocumentReference/docref-var-change-description> ;
       fhir:reference [ fhir:v "DocumentReference/docref-var-change-description" ] ;
       fhir:display [ fhir:v "Change description and justification" ]
     ]
  ] [
     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 "proposed-labelling" ] ;
         fhir:display [ fhir:v "Proposed Labelling" ]
       ] )
     ] ;
     fhir:value [
       a fhir:Reference ;
       fhir:link <http://hl7.org/fhir/DocumentReference/docref-epi-annotated-v1> ;
       fhir:reference [ fhir:v "DocumentReference/docref-epi-annotated-v1" ] ;
       fhir:display [ fhir:v "Annotated ePI v1 (proposal)" ]
     ]
  ] [
     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 "epi-bundle" ] ;
         fhir:display [ fhir:v "ePI Bundle" ]
       ] )
     ] ;
     fhir:value [
       a fhir:Reference ;
       fhir:link <http://hl7.org/fhir/DocumentReference/docref-epi-clean-v1> ;
       fhir:reference [ fhir:v "DocumentReference/docref-epi-clean-v1" ] ;
       fhir:display [ fhir:v "Clean ePI v1 (proposal)" ]
     ]
  ] ) ; # 
  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 "validation-report" ] ;
         fhir:display [ fhir:v "Validation Report" ]
       ] )
     ] ;
     fhir:value [
       a fhir:Reference ;
       fhir:link <http://hl7.org/fhir/DocumentReference/docref-var-validation-report> ;
       fhir:reference [ fhir:v "DocumentReference/docref-var-validation-report" ] ;
       fhir:display [ fhir:v "Variation validation report" ]
     ]
  ] ) . # 

<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-var-cover-letter> a fhir:DocumentReference .

<http://hl7.org/fhir/DocumentReference/docref-var-application-form> a fhir:DocumentReference .

<http://hl7.org/fhir/DocumentReference/docref-var-change-description> a fhir:DocumentReference .

<http://hl7.org/fhir/DocumentReference/docref-epi-annotated-v1> a fhir:DocumentReference .

<http://hl7.org/fhir/DocumentReference/docref-epi-clean-v1> a fhir:DocumentReference .

<http://hl7.org/fhir/DocumentReference/docref-var-validation-report> a fhir:DocumentReference .