@prefix fhir: . @prefix owl: . @prefix rdf: . @prefix rdfs: . @prefix xsd: . # - resource ------------------------------------------------------------------- a fhir:Task ; fhir:nodeRole fhir:treeRoot ; fhir:id [ fhir:v "scenario1-07-final-decision"] ; # fhir:meta [ fhir:versionId [ fhir:v "3" ] ; fhir:lastUpdated [ fhir:v "2026-04-20T09:00:00+01:00"^^xsd:dateTime ] ; fhir:profile ( [ fhir:v "http://hl7.org/fhir/uv/apix/StructureDefinition/apix-task"^^xsd:anyURI ; fhir:l ] ) ] ; # fhir:language [ fhir:v "en"] ; # fhir:text [ fhir:status [ fhir:v "additional" ] ; fhir:div [ fhir:v "
Task: Approval Letter / Positive Decision

HL7 FHIR R5 – APIX Implementation Guide

Task Description
Final Decision: Approval for Type IB Variation
Core Task Information
Version ID3 Task IDin production system will be the same as scenario1-01-initial-submission Instance UUIDurn:uuid:999e7d2a-8b1c-4d9f-9a2e-1f6c9d8e7b3dGroup Identifierurn:uuid:workflow-group-id-12345Procedure IDPROC-2025-12345Task StatuscompletedBusiness StatusApprovedIntentproposalPriorityroutine
CodeType IB Variation (variation-type-ib)Authored2025-11-15T09:00:00+01:00Last Updated2026-04-20T09:00:00+01:00
Parties Involved
Requester
SynthPharma AG
Address: 123 Synthetic Research Blvd, 4000 Basel, Switzerland
Contact: Dr. John Doe, Head of Regulatory Affairs
Email: john.doe@synthpharma.example
Performer
European Medicines Agency – Human Medicines Evaluation Division
Address: Domenico Scarlattilaan 6, 1083 HS Amsterdam, Netherlands
Contact: Scientific and Regulatory Management
Email: srm@ema.example.eu
Input Documents8 documents
Module 1
Cover Letter
cover-letter
http://example.org/FHIR/DocumentReference/cover-letter
Cover Letter
Application Form
application-form
http://example.org/FHIR/DocumentReference/application-form
Application Form
Annotated Label
annotated-label
http://example.org/FHIR/DocumentReference/annotated-label
SPC, Labelling and Package Leaflet
Clean Label
clean-label
http://example.org/FHIR/DocumentReference/clean-labele
SPC, Labelling and Package Leaflet
Module 3
Stability Summary
cmc-stability-summary
http://example.org/FHIR/DocumentReference/stability-summary
Stability Summary and Conclusion
Stability Data
cmc-stability-data
http://example.org/FHIR/DocumentReference/stability-data
Stability Data
DS Stability Data
cmc-ds-stability-data
http://example.org/FHIR/DocumentReference/stability-drug-substance
Stability (Drug Substance)
Output Documents4 documents
Regulator Output
Acknowledgement of Receipt
acknowledgement-receipt
http://example.org/FHIR/DocumentReference/output-ack
Acknowledgement of Receipt
Validation Report
validation-report
http://example.org/FHIR/DocumentReference/output-validation
Validation Report
Approval Letter
regulatory-document
http://example.org/FHIR/DocumentReference/docref-approval-letter
Approval Letter
Final Assessment Report
regulatory-document
http://example.org/FHIR/DocumentReference/docref-assessment-report
Final Assessment Report
HL7 FHIR R5 – API Exchange for Medicinal Products (APIX)
Generated Render
"^^rdf:XMLLiteral ] ] ; # fhir:identifier ( [ fhir:use [ fhir:v "official" ] ; fhir:type [ fhir:coding ( [ fhir:system [ fhir:v "http://terminology.hl7.org/CodeSystem/v2-0203"^^xsd:anyURI ; fhir:l ] ; fhir:code [ fhir:v "RI" ] ; fhir:display [ fhir:v "Resource identifier" ] ] ) ] ; fhir:system [ fhir:v "http://example.org/european-med-agency/task-id"^^xsd:anyURI ; fhir:l ] ; fhir:value [ fhir:v "urn:uuid:f1500e1d-599f-47a6-a38c-ca60a5189726" ] ] [ fhir:use [ fhir:v "official" ] ; fhir:system [ fhir:v "http://example.org/ema.europa.eu/procedure-number"^^xsd:anyURI ; fhir:l ] ; fhir:value [ fhir:v "PROC-2025-12345" ] ] ) ; # fhir:groupIdentifier [ fhir:use [ fhir:v "official" ] ; fhir:system [ fhir:v "http://example.org/european-med-agency/work-flow-group-id"^^xsd:anyURI ; fhir:l ] ; fhir:value [ fhir:v "urn:uuid:workflow-group-id-12345" ] ] ; # 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:l ] ; fhir:code [ fhir:v "approved" ] ; fhir:display [ fhir:v "Approved" ] ] ) ] ; # 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:l ] ; 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 "2026-04-20T09:00:00+01:00"^^xsd:dateTime] ; # fhir:requester [ fhir:l ; fhir:reference [ fhir:v "Organization/org-synthpharma-ag" ] ; fhir:display [ fhir:v "SynthPharma AG" ] ] ; # fhir:owner [ fhir:l ; fhir:reference [ fhir:v "Organization/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/ctd-section"^^xsd:anyURI ; fhir:l ] ; fhir:code [ fhir:v "1.0" ] ; fhir:display [ fhir:v "Cover Letter" ] ] ) ] ; fhir:value [ a fhir:Reference ; fhir:l ; fhir:reference [ fhir:v "DocumentReference/doc1" ] ] ] [ fhir:type [ fhir:coding ( [ fhir:system [ fhir:v "http://hl7.org/fhir/uv/apix/CodeSystem/ctd-section"^^xsd:anyURI ; fhir:l ] ; fhir:code [ fhir:v "application-form" ] ; fhir:display [ fhir:v "Application Form" ] ] ) ] ; fhir:value [ a fhir:Reference ; fhir:l ; fhir:reference [ fhir:v "DocumentReference/doc2" ] ] ] [ fhir:type [ fhir:coding ( [ fhir:system [ fhir:v "http://hl7.org/fhir/uv/apix/CodeSystem/ctd-section"^^xsd:anyURI ; fhir:l ] ; fhir:code [ fhir:v "1.3.1" ] ; fhir:display [ fhir:v "SPC, Labelling and Package Leaflet" ] ] ) ] ; fhir:value [ a fhir:Reference ; fhir:l ; fhir:reference [ fhir:v "DocumentReference/doc3" ] ] ] [ fhir:type [ fhir:coding ( [ fhir:system [ fhir:v "http://hl7.org/fhir/uv/apix/CodeSystem/ctd-section"^^xsd:anyURI ; fhir:l ] ; fhir:code [ fhir:v "1.3.1" ] ; fhir:display [ fhir:v "SPC, Labelling and Package Leaflet" ] ] ) ] ; fhir:value [ a fhir:Reference ; fhir:l ; fhir:reference [ fhir:v "DocumentReference/doc4" ] ] ] [ fhir:type [ fhir:coding ( [ fhir:system [ fhir:v "http://hl7.org/fhir/uv/apix/CodeSystem/ctd-section"^^xsd:anyURI ; fhir:l ] ; fhir:code [ fhir:v "1.3.2" ] ; fhir:display [ fhir:v "Mock-ups" ] ] ) ] ; fhir:value [ a fhir:Reference ; fhir:l ; fhir:reference [ fhir:v "DocumentReference/doc5" ] ] ] [ fhir:type [ fhir:coding ( [ fhir:system [ fhir:v "http://hl7.org/fhir/uv/apix/CodeSystem/ctd-section"^^xsd:anyURI ; fhir:l ] ; fhir:code [ fhir:v "3.2.P.8.1" ] ; fhir:display [ fhir:v "Stability Summary and Conclusion" ] ] ) ] ; fhir:value [ a fhir:Reference ; fhir:l ; fhir:reference [ fhir:v "DocumentReference/doc6" ] ] ] [ fhir:type [ fhir:coding ( [ fhir:system [ fhir:v "http://hl7.org/fhir/uv/apix/CodeSystem/ctd-section"^^xsd:anyURI ; fhir:l ] ; fhir:code [ fhir:v "3.2.P.8.3" ] ; fhir:display [ fhir:v "Stability Data" ] ] ) ] ; fhir:value [ a fhir:Reference ; fhir:l ; fhir:reference [ fhir:v "DocumentReference/doc7" ] ] ] [ fhir:type [ fhir:coding ( [ fhir:system [ fhir:v "http://hl7.org/fhir/uv/apix/CodeSystem/ctd-section"^^xsd:anyURI ; fhir:l ] ; fhir:code [ fhir:v "3.2.S.7" ] ; fhir:display [ fhir:v "Stability (Drug Substance)" ] ] ) ] ; fhir:value [ a fhir:Reference ; fhir:l ; fhir:reference [ fhir:v "DocumentReference/doc8" ] ] ] ) ; # fhir:output ( [ fhir:type [ fhir:coding ( [ fhir:system [ fhir:v "http://hl7.org/fhir/uv/apix/CodeSystem/ctd-section"^^xsd:anyURI ; fhir:l ] ; fhir:code [ fhir:v "acknowledgement-receipt" ] ; fhir:display [ fhir:v "Acknowledgement of Receipt" ] ] ) ] ; fhir:value [ a fhir:Reference ; fhir:l ; fhir:reference [ fhir:v "DocumentReference/output-ack" ] ; fhir:display [ fhir:v "Acknowledgement of Receipt" ] ] ] [ fhir:type [ fhir:coding ( [ fhir:system [ fhir:v "http://hl7.org/fhir/uv/apix/CodeSystem/ctd-section"^^xsd:anyURI ; fhir:l ] ; fhir:code [ fhir:v "validation-report" ] ; fhir:display [ fhir:v "Validation Report" ] ] ) ] ; fhir:value [ a fhir:Reference ; fhir:l ; fhir:reference [ fhir:v "DocumentReference/output-validation" ] ; fhir:display [ fhir:v "Validation Report" ] ] ] [ fhir:type [ fhir:coding ( [ fhir:system [ fhir:v "http://hl7.org/fhir/uv/apix/CodeSystem/ctd-section"^^xsd:anyURI ; fhir:l ] ; fhir:code [ fhir:v "approval-letter" ] ; fhir:display [ fhir:v "Approval Letter" ] ] ) ] ; fhir:value [ a fhir:Reference ; fhir:l ; fhir:reference [ fhir:v "DocumentReference/docref-approval-letter" ] ; fhir:display [ fhir:v "Approval Letter" ] ] ] [ fhir:type [ fhir:coding ( [ fhir:system [ fhir:v "http://hl7.org/fhir/uv/apix/CodeSystem/ctd-section"^^xsd:anyURI ; fhir:l ] ; fhir:code [ fhir:v "assessment-report" ] ; fhir:display [ fhir:v "Assessment Report" ] ] ) ] ; fhir:value [ a fhir:Reference ; fhir:l ; fhir:reference [ fhir:v "DocumentReference/docref-assessment-report" ] ; fhir:display [ fhir:v "Final Assessment Report" ] ] ] ) . # a fhir:Uv . a fhir:Uv . a fhir:Uv . a fhir:Uv . a fhir:Uv . a fhir:Uv . a fhir:Uv . a fhir:Uv . a fhir:Uv . a fhir:Uv . a fhir:Uv . a fhir:Uv . a fhir:Uv . a fhir:Uv . # -------------------------------------------------------------------------------------