10/11 October 2023
In December 2022, the Questions & Answers (Q&A) documents relating to centralised marketing authorisation procedures were again 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 the different stages of the centralised marketing authorisation application.
The Q&As document 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 items:
In the answer to question 1.11. What should I do if I want to submit multiple/duplicate applications for the same medicinal product? the new e-mail address which can be used for sending the notifications has been included.
In section 3.4. Compliance, Environmental Risk Assessment and Pharmacovigilance, section 3.4.3. What should I submit if my medicinal product contains or consists of genetically modified organisms (GMOs)? has been fundamentally renewed and again divided into seven subsections. These in turn partly contain further subdivisions, such as subheading 18.104.22.168. Examples of information to be provided in module 1.6.2. for product types covered by an existing CAF, which deals with the different types (genetically modified cells, AAV vectors and other vector types) in three further subdivisions.
In paragraph 3.5. Risk Management Plan (RMP), sections 3.5.5. How shall I present my RMP? and 3.5.7. When and how will the RMP summary or the full RMP be published? were updated.
In paragraph 4.1. How and to whom should I submit my dossier? the section "Working documents outside the eCTD structure" has been added.
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, also contains some additions, revisions and innovations in the following passages:
The new versions of the "Q&A" documents for central procedures can be found at: