The Directive I-SMI.RL.01, “Conduct of inspections of establishments manufacturing or distributing medicinal products or collecting blood.” Version 4.0 was approved on 21 October 2024 and has thus entered into force.
In February 2025, the “Questions and Answers (Q&A)” document related to centralized procedures was updated and published on the website of the European Medicines Agency (EMA).
The new edition of the Q&A document “European Medicines Agency post-authorization procedural advice for users of the centralised procedure” includes some additions and revisions and addresses relevant issues in the post-grant phase of marketing authorization.
Below are references to the chapters and questions that have been changed:
Chapter 1 Type IA Variations
Questions:
- 4. How shall I present and submit my Type IA/ IAIN Variation(s)?
- 12. When do I have to submit revised product information? In all languages?
Chapter 2 Type IB variations
Questions:
- 4. How shall I present and submit my Type IB Variation?
In the related answer, the paragraph “Variations to implement changes for generic/hybrid/biosimilar products” was added.
- 5. When shall I submit my Type IB Variation?
- 10. How should I submit revised product information? In all languages?
Chapter 3 Type II variations
Questions:
- 16. When do I have to submit revised product information? In all languages?
Chapter 6 Worksharing of variations
Questions:
- 10. When do I have to submit revised product information? In all languages?
Chapter 19 Transfer of Marketing Authorisation
Questions:
- 2. How shall I present my application for the Transfer of Marketing Authorisation?
Chapter 22 Article 61(3) Notifications
Questions:
- 4. How shall I present my 61(3) Notification?
SOURCES: