EMA: Renewal of Q&A Document for "Centralized Procedures"

In February 2025, the "Questions & Answers (Q&A)" document relating to centralized procedures was updated and published on the website of the European Medicines Agency (EMA).

The new version of the Q&A document "European Medicines Agency post-authorisation procedural advice for users of the centralised procedure", which addresses issues that may be relevant after marketing authorisation has been granted, contains some additions and revisions in the following passages:

Chapter 1 Type IA Variations

There have been updates to the following questions:

• 1.4. How shall I present and submit my Type IA/ IAIN Variation(s)?
• 1.12. When do I have to submit revised product information? In all languages?

Chapter 2 Type IB variations

The following questions have been adapted in this chapter:

• 2.4. How shall I present and submit my Type IB Variation?
• 2.5. When shall I submit my Type IB Variation?
• 2.10. How should I submit revised product information? In all languages?

In the answer to question 2.4., the paragraph "Variations to implement changes for generic/hybrid/biosimilar products" was added.

Chapter 3 Type II variations

In chapter 3, the answer to one question has been revised:

• 3.16. When do I have to submit revised product information? In all languages?

Chapter 6 Worksharing of variations

There were updates in the following question:

• 6.10. When do I have to submit revised product information? In all languages?

Chapter 19 Transfer of Marketing Authorisation

In chapter 19, the answer to the following question has been revised:

• 19.2. How shall I present my application for the Transfer of Marketing Authorisation?

Chapter 22 Article 61(3) Notifications

The following question has been adapted in this chapter:

• 22.4. How shall I present my 61(3) Notification?

The latest version of the "Q&A" document for central procedures "European Medicines Agency post-authorisation procedural
advice for users of the centralised procedure" can be found here.