EMA: Update of the Q&A Documents for "Centralised Procedures"

In October 2024, the "Questions & Answers (Q&A)" documents relating to centralised marketing authorisation procedures were again updated and published on the website of the European Medicines Agency (EMA). These Q&A catalogues are intended to provide assistance and guidelines for marketing authorisation holders and applicants for centralised procedures and provide answers to possible questions at different stages of the centralised marketing authorisation application.

The list of questions relating to topics before and during the application for a centralised procedure 'European Medicines Agency pre-authorisation procedural advice for users of the centralised procedure' has been supplemented or updated to include the following points:

Chapter 3 Preparing the dossier

The paragraph "3.3.9. Can I apply for Design Space or Process Analytical Technology (PAT) in my application?" has been updated and now contains four subsections.

Furthermore, the paragraph "3.4.2 When do I have to submit an Environmental Risk Assessment (ERA)?" has been updated.

Chapter 5 Assessment of the application

In Chapter 5, the subsection "5.2.2 When can I expect a pre-approval GCP inspection and how are they conducted?" was revised.

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, contains some additions and revisions in the following passage:

Chapter 4 Extension of marketing authorisation

The following question has been updated:

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

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

• Topics before and during the application
• Topics after the authorisation has been granted