Regulatory Task Record
API Exchange for Medicinal Products (APIX) - Official Extract
Date: November 15, 2025
Time: 09:00:00 UTC+01:00
Control ID: 999e7d2a-8b1c-4d9f
Version: 1.0 (Original)
1. Task Overview
| Type: | Type IB Variation |
|---|---|
| Status: | REQUESTED |
| Intent: | ORDER |
| Priority: | ROUTINE |
2. Involved Parties
Requester (Applicant)
SynthPharma AG
123 Synthetic Research Blvd, 4000 Basel, Switzerland
Representative: Dr. John Doe
Performer (Regulator)
European Medicines Agency
Domenico Scarlattilaan 6, 1083 HS Amsterdam, Netherlands
Department: Human Medicines Evaluation Division
3. Submission Content Manifest
The following documents are attached to this regulatory task:
| Type | Code | Filename |
|---|---|---|
| Module 1 | cover-letter | Cover Letter.pdf |
| Module 1 | application-form | Application Form.pdf |
| Module 1 | annotated-label | Annotated Label.pdf |
| Module 1 | pack-mockup | Pack Mockup.pdf |
| Module 3 | stability-summary | CMC Doc 1 - Summary.pdf |
| Module 3 | stability-data | CMC Doc 2 - Data.pdf |
Digital Signature Valid
Nov 15, 2025
Nov 15, 2025
Generated by APIX Reference Implementation • Page 1 of 1