Task: Approval Letter / Positive Decision

HL7 FHIR R5 – APIX Implementation Guide

Task Description

Final Decision: Approval for Type IB Variation

Core Task Information

Version ID 3 Task ID example-workflow-4-decision Instance UUID urn:uuid:999e7d2a-8b1c-4d9f-9a2e-1f6c9d8e7b3d Group Identifier urn:uuid:workflow-group-id-12345 Procedure ID PROC-2025-12345 Task Status completed Business Status Approved Intent proposal Priority routine

Code Approval Letter / Positive Decision (approval) Authored 2025-04-20 09:00:00 UTC+01:00 Last Updated 2025-04-20 09:00:00 UTC+01:00

Parties Involved

Requester
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
Performer
SynthPharma AG
Address: 123 Synthetic Research Blvd, 4000 Basel, Switzerland
Contact: Dr. John Doe, Head of Regulatory Affairs
Email: john.doe@synthpharma.example
Output Documents 2 documents

Output Documents (Decision)

Approval Letter
regulatory-document
approval-letter.pdf
Final Assessment Report
regulatory-document
final-assessment-report.pdf