Task: Response to Information Request

HL7 FHIR R5 – APIX Implementation Guide

Task Description

Response to Questions: Submission of additional stability data

Core Task Information

Version ID 1 Task ID example-workflow-3-response Instance UUID urn:uuid:888e7d2a-8b1c-4d9f-9a2e-1f6c9d8e7b3c Group Identifier urn:uuid:workflow-group-id-12345 Procedure ID PROC-2025-12345 Task Status requested Business Status Submitted Intent proposal Priority routine

Code Response to Information Request (response-to-questions) Authored 2025-03-15 10:00:00 UTC+01:00 Last Updated 2025-03-15 10:00:00 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 Documents 2 documents

Input Documents (Responses)

Applicant Responses
regulatory-document
response-to-questions.pdf
Annex: Raw Stability Data
regulatory-document
raw-stability-data.json