Centralised Procedures: Updated Q&As
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In July and September 2025, the 'Questions & Answers (Q&A)' documents relating to centralised authorisation procedures were 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 centralised procedure, 'European Medicines Agency pre-authorisation procedural advice for users of the centralised procedure', was supplemented and updated with the following points:
Chapter 1 Types of applications and applicants
In Chapter 1, the passages relating to the questions '1.6. What will be the legal basis for my application?', '1.7. What is an application for a paediatric use marketing authorisation (PUMA)?' and '1.10. What should I do if I want to submit multiple/duplicate applications for the same medicinal product?' have been updated and revised.
Chapter 2 Steps prior to submitting the application
The sections of the following questions were updated and adjusted:
- '2.4. What is the procedure for appointment of Rapporteurs/Co-Rapporteurs and their assessment teams?'
- '2.7. How should I notify a change in the contact person and/or intended submission date of my application?'
Chapter 3 Preparing the dossier
This contained the answers to the questions '3.2.2. What aspects should I consider if my medicinal product has been designated as an orphan medicinal product at the time of submission of my application?', "3.2.3. What aspects should I consider if the designation for my orphan medicinal product is still pending at the time of submission of my application for marketing authorisation?' and '3.3.4. Is my product subject to batch release by an Official Medicines Control Laboratory?' have been expanded and revised. The question '3.3.6. In case the orphan designation needs to be removed, how should I proceed?" has been added.
Chapter 5 Assessment of the application
In Chapter 5, the answers to questions '5.1.1. How long does it take for my application to be reviewed?' and '5.1.3. What is the QRD review of product information?' have been updated.
Chapter 6 Data exclusivity, marketing protection and market exclusivity
An addition has been made to the answer text for question '6.1.5. What is the period of protection for a PUMA?'
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 fundamental additions, deletions and revisions in the following chapters and their questions:
- Chapter 1 Type IA Variations
- Chapter 3 Type II variations
- Chapter 5 Grouping of variations
- Chapter 8 Pre-submission queries service
- Chapter 22 Article 61(3) Notifications
The new versions of the 'Q&A' documents for central procedures can be found at: