EMA: Q&A Documents on Centralised Procedures updated again

Recommendation

17/18 September 2024

Drug Master File Procedures in the EU, the US and Japan - Live Online Training
With updates on the CEP 2.0!

The Questions & Answers (Q&A) documents relating to centralised marketing authorisation procedures, last revised in June, have now been updated again and published on the European Medicines Agency (EMA) website. These Q&As are intended to provide guidance and guidelines for marketing authorisation holders and applicants of centralised procedures and provide answers to potential questions at different stages of the centralised marketing authorisation application process.

The list of questions with regard to topics prior to and during the application for a centralised procedure - "European Medicines Agency pre-authorisation procedural advice for users of the centralised procedure" - has been extended respectively updated with the following points

Chapter 3 Preparing the dossier

In paragraph 3.3. Quality, question 3.3.1. "What information relating to the manufacturing, testing and batch release sites should be provided as part of my application?" and its answer have been revised and the item "testing" has been added.

Chapter 5 Assessment of the application

In paragraph 5.2. Inspections, section 5.2.1.2. Pre-submisson notification has been amended by several passages and the item "testing" has also been added.

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

Chapter 3 Type II variations

There were updates in the following three questions:

• 3.7. How shall I present my type II variation application? 
• 3.8. How shall I present my application for a new or modified therapeutic indication? 
• 3.16. When do I have to submit revised product information? In all languages?

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

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