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 02 validation

Page standards status: Informative
Task: Type IB Variation

HL7 FHIR R5 – APIX Implementation Guide

Task Description
Validation of Type IB Variation
Core Task Information
Version ID2Task IDtask-workflow-step2Instance UUIDurn:uuid:workflow-step1-instanceGroup Identifierurn:uuid:workflow-group-id-12345Procedure IDEMEA/H/C/001234/IB/0025Task StatusacceptedBusiness StatusValidation SuccessfulIntentorderPriorityroutine
CodeType IB Variation (variation-type-ib)Authored2025-11-15 09:00:00 UTC+01:00Last Updated2025-11-20 14:30:00 UTC+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 Documents10 documents
Module 1
Cover Letter
cover-letter
Cover Letter.pdf
Application Form
application-form
Application Form.pdf
Annotated Label
annotated-label
Annotated Label.pdf
Clean Label
clean-label
Clean Label.pdf
Pack Mockup
pack-mockup
Pack Mockup.pdf
Module 3
Stability Summary
cmc-stability-summary
CMC Doc 1 - Summary.pdf
Stability Data
cmc-stability-data
CMC Doc 2 - Data.pdf
Stability Commitment
cmc-stability-commitment
CMC Doc 3 - Commitment.pdf
DS Stability Summary
cmc-ds-stability-summary
CMC Doc 4 - DS Summary.pdf
DS Stability Data
cmc-ds-stability-data
CMC Doc 5 - DS Data.pdf
Output Documents2 documents
Regulator Output
Acknowledgement of Receipt
acknowledgement-receipt
Acknowledgement_Letter.pdf
Validation Report
validation-report
Validation_Report.pdf
HL7 FHIR R5 – API Exchange for Medicinal Products (APIX)
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