EMA: New Update of the Q&A Documents on Centralised Procedures

Again, in June 2023, the Questions & Answers (Q&A) documents with regard to centralised marketing authorisation procedures were revised and published on the European Medicines Agency (EMA) website. The Q&As, which can be used by marketing authorisation holders and applicants of centralised procedures, provide answers to potential questions at different stages of the centralised marketing authorisation application process.

The questionnaire on issues prior to and during the application of a centralised procedure - "European Medicines Agency pre-authorisation procedural advice for users of the centralised procedure" - has been updated or revised to include the following items:

Chapter 3 Preparing the dossier

In Chapter 3, the question 3.5.15. When should I submit the RMP Annex 1 to EudraVigilance? has been updated.

Chapter 5 Assesment of the application

Chapter 5 now contains the revised version of question 5.1.10. How and when can I withdraw my application? which was last revised in February 2019.

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 the marketing authorisation has been granted, also contains additions and innovations in the following passages:

Chapter 3 Type II Variations

In Chapter 3, the question 3.26. How and when can I withdraw my Type II variation application? was newly included.

Chapter 4 Extension of marketing authorisation

Chapter 4 also contains a new question. Question 4.20. How and when can I withdraw my extension application? has been added.

The new versions of the "Q&A" documents for central procedures can be found at:

• Topics before and during application 
• Topics after the granting of authorisation