Updated Q&As for Centralised Procedures - pre-authorisation procedural advice

In October 2025, the 'Questions & Answers (Q&A)' document relating to centralised authorisation procedures was updated again and published on the website of the European Medicines Agency (EMA).

The list of questions relating to topics prior 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 3 Preparing the dossier

The answers to the following questions have been updated and revised:

• 3.5.6.   What template should I use for the RMP submission?
• 3.5.7.   When and how will the full RMP be published?
• 3.5.13. How will my RMP be reviewed?
• 3.5.14. Can I submit a version of the RMP after the opinion to reflect the last-minute changes made during the CHMP?

Chapter 5 Assessment of the application

In Chapter 5, the answer to question '5.1.11. Can EMA assessment or inspection documents be shared with regulators outside the EU?' has been supplemented with the addition 'To facilitate this information, it is recommended to use this template.'

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

• Issues before and during the application process