EMA: Q&A Documents for "Centralized Procedures" revised

In December 2024, the "Questions & Answers (Q&A)" documents relating to centralized procedures were once again updated and published on the website of the European Medicines Agency (EMA).

The list of questions relating to topics before and during the authorisation application of a centralized procedure "European Medicines Agency pre-authorisation procedural advice for users of the centralised procedure" was supplemented or updated by the following points:

Chapter 2 Steps prior to submitting the application

In Chapter 2, the answers to the two questions "2.4.1.1. Requesting the appointment of CHMP/PRAC/CAT Rapporteurs/Co-Rapporteurs and their assessment teams" and "2.7. How should I notify a change in the contact person and/or intended submission date of my application?" have been revised.

Chapter 3 Preparing the dossier

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

Chapter 4 Submission, validation and fees

The paragraph "4.4. What fee do I have to pay?" has been fundamentally revised and reference is now made to the EMA's existing document on costs ("Fee Q&A in Annex I, Section 2").

Chapter 5 Assessment of the application

An addition to the new cost regulation ("Fee Q&A") has also been included in Chapter 5 under "5.1.1 How long does it take for my application to be evaluated?".

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

Chapter 1 Type IA Variations

The following questions have been updated:

• 1.4. How shall I present and submit my Type IA/ IAIN Variation(s)?
• 1.8. What fee do I have to pay for a Type IA/ IAIN variation?

Chapter 2 Type IB variations

In this chapter, the following question has been amended:

• 2.8. What fee do I have to pay for a Type IB Variation?

Chapter 3 Type II variations

In Chapter 3, the answers to two questions have been revised:

• 3.13. Which post-opinion steps apply to my type II variation and when can I implement the approved changes?
• 3.14. What fee do I have to pay for a type II variation?

Chapter 4 Extension of marketing authorisation

The following questions have been updated:

• 4.12. How shall my Extension Application be handled (timetable)?
• 4.13. What fee do I have to pay for an Extension Application?

Chapter 5 Grouping of variations

In this chapter, the following question has been amended:

• 5.8. What fee do I have to pay for grouped variations?

Chapter 6 Worksharing of variations

In Chapter 6, the answers to two questions have been revised:

• 6.8. How and when will the marketing authorisations be updated following a worksharing procedure? When can I implement the approved changes?
• 6.9. What fee do I have to pay for variation applications under worksharing?

Chapter 10 Annual Re-assessment

There were updates in the following question:

• 10.10. Do I have to pay fees for an annual re-assessment?

Chapter 11 Renewal

In this chapter, the following question has been amended:

• 11.6. What fee do I have to pay for a renewal?

Chapter 19 Transfer of Marketing Authorisation

In Chapter 19, the answer text for the following question has been revised:

• 19.6. What fee do I have to pay for my Transfer of Marketing Authorisation application?

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

• Topics before and during the authorisation procedure
• Topics after marketing authorisation has been granted