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

In March 2024, the "Questions & Answers (Q&A)" documents relating to centralised 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 2 Steps prior to submitting the application

In Chapter 2, section 2.9 "How are marketing authorisation application pre-submission interactions structured at the EMA?" has been revised and contains adjustments and updates in the subsections 2.9.3. and 2.9.5.

Chapter 3 Preparing the dossier

In section 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 in the subsections 3.3.1.1. and 3.3.1.2. have been revised and supplemented. In addition, question 3.3.2 "What batch release arrangements in the EEA are required for my medicinal product?" has been revised in the subsections 3.3.2.1. and 3.3.2.2.

Chapter 5 Assessment of the application

In section 5.1 Procedure, the answers to questions 5.1.1, 5.1.7 and 5.1.11 have been adapted. The question 5.1.13. "What is the CHMP early contact with patient and healthcare professional organisations?" and its answer have been completely added.
In section 5.2 Inspections, section 5.2.1 "When can I expect a pre-authorisation GMP inspection and how are they conducted?" has been supplemented and expanded.

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 authorisation has been granted, contains some additions, revisions and innovations in the following passages:

Chapter 1 Type IA Variations

The answer to question 1.3 "Is the (Co-) Rapporteur involved in the review of Type IA/IAIN variations?" has been adapted.

Chapter 3 Type II Variations

There have been updates to the following four questions:

• 3.11. How shall my Type II application be handled (timetable)? 
• 3.25. When will I get a PIP compliance statement? 
• 3.27. Who is my contact at the European Medicines Agency during a type II variation, including extension of indications? 
• 3.28. Whom should I contact if I have a pre-submission question when preparing my type II variation application?

Chapter 4 Extension of marketing authorisation

In this chapter, adjustments have been made to section 4.12 "How shall my Extension Application be handled (timetable)?".

Chapter 13 Post Authorisation Safety Study (PASS)

In Chapter 13, Section 13.2 "Under which procedure should I submit my non-interventional imposed PASS?" has been revised.

Chapter 19 Transfer of Marketing Authorisation

There have been updates to the following seven questions:

• 19.1 What is a Transfer of Marketing Authorisation? 
• 19.2 How shall I present my application for the Transfer of Marketing Authorisation? 
• 19.5 How to choose the implementation date? 
• 19.8 How to handle remaining Post-authorisation measures and recommendations when transferring a Marketing Authorisation? 
• 19.13 Can I change the name of a medicinal product as part of a transfer application? 
• 19.14 Will there be any publication on the Transfer of Marketing Authorisation? 
• 19.15 Who should I contact if I have a question when preparing my application or during the procedure?

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

• Topics before and during the application 
• Post-authorisation topics