Q&As for Centralized Procedures - further Update

In December 2025, the "Questions & Answers (Q&A)" document relating to centralized authorization procedures was updated again and published on the website of the European Medicines Agency (EMA).

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

Chapter 2 Steps prior to submitting the application

The texts in sub-section '2.4. What is the procedure for appointment of Rapporteurs/Co-Rapporteurs and their assessment teams?' have been updated and revised. This is primarily reflected in the texts of the following question:

• '2.4.2. Appointment of (Co-) Rapporteurs and their assessment teams for different application types/procedures'

Chapter 5 Assessment of the application

In Chapter 5, the answer to question '5.1.1. How long does it take for my application to be evaluated?' has been supplemented with additional text on the topics '1. Calculation of timetable' and '2. Calculation of timetable, only in case of an advanced therapy medicinal product, where CHMP must consult the CAT'. In addition, a few minor formal changes and corrections have been made.

The new version of the 'Q&A' document for centralized procedures can be found at:

• Topics before and during the application process