APIX Task – List of Questions

Task Description

Regulatory Questions: Request for additional stability data

Core Task Information

Version ID 1 Task ID example-workflow-2-questions Instance UUID urn:uuid:778e7d2a-8b1c-4d9f-9a2e-1f6c9d8e7b3b Group Identifier urn:uuid:workflow-group-id-12345 Procedure ID PROC-2025-12345 Task Status requested Business Status Clock Stop Intent proposal Priority routine

Code Information Request (information-request) Authored 2025-03-01 14:30:00 UTC+01:00 Last Updated 2025-03-01 14:30:00 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 1 document

Output Documents (Questions)

List of Questions (LoQ)

regulatory-document
list-of-questions-EMA.pdf