scenario1-07-final-decision - API for the Exchange of Medicinal Product Information (APIX) v0.1.0

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 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