API for the Exchange of Medicinal Product Information (APIX)
0.1.0 - ci-build International flag

API for the Exchange of Medicinal Product Information (APIX), 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

Example Task: scenario1-07-final-decision

Page standards status: Informative
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 Updated2025-12-22T09:00:00+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
Health Authority – Regulatory Review Division
Address: Regulatory Authority Headquarters, 1083 HS Capital City, Country
Contact: Scientific and Regulatory Management
Email: regulatory@health-authority.example
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-label
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)
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