In April 2023, the Questions & Answers (Q&A) documents related to centralised marketing authorisation procedures were revised and published on the European Medicines Agency (EMA) website. The Q&As, which can be used by marketing authorisation holders and applicants of centralised procedures, provide answers to possible questions at different stages of the centralised marketing authorisation application process.
The questionnaire on issues prior to and during the application of a centralised procedure “European Medicines Agency pre-authorisation procedural advice for users of the centralised procedure” has been updated or revised to include the following item:
- Chapter 4 Submission, validation and fees – Paragraph 4.1 “How and to whom should I submit my dossier?”, which was only revised in December 2022, now also contains the sub-item “Submission of responses to list of questions/list of outstanding issues”. 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 the marketing authorisation has been granted, also contains an addition in the following passage:
- Chapter 4 Extension of marketing authorisation – in paragraph 4.5 “How shall I present my Extension Application?” the sub-item “Submission of responses to list of questions/list of outstanding issues” has been added.
The new versions of the “Q&A” documents for centralised procedures can be found at: