Revised Q&As for Centralised Procedures - Post-authorisation

In November and December 2025, the Questions & Answers (Q&A) document related to centralised authorisation procedures was updated again 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 topics that may be relevant after marketing authorisations has been granted, contains fundamental additions, deletions and revisions in the following chapters and their questions:

• Chapter 1 Type IA Variations
• Chapter 2 Type IB variations
• Chapter 3 Type II variations
• Chapter 4 Extension of marketing authorisation
• Chapter 5 Grouping of variations
• Chapter 6 Worksharing of variations
• Chapter 7 Classification of changes  
• Chapter 9 Changing the (Invented) Name of a Centrally Authorised Medicinal Product
• Chapter 13 Post Authorisation Safety Study (PASS)
• Chapter 14 Post-Authorisation efficacy study (PAES)
• Chapter 15 Post-Authorisation Measures (PAMs)
• Chapter 16 Risk Management Plan
• Chapter 17 Periodic Safety Update Reports (PSURs)
• Chapter 18 Article 46 paediatric study submission
• Chapter 19 Transfer of Marketing Authorisation

Chapter 3 in particular contains extensive updates and new information, which is also evident from the fact that almost every subchapter contains changes.

The new version of the ‘Q&A’ document for central procedures can be found at:

• post-authorisation procedural