EMA: Q&A documents on the topic of "Centralised procedures" revised

The "Questions & Answers (Q&A)" documents relating to centralised marketing authorisation procedures were revised again in September and November 2023 and published on the website of the European Medicines Agency (EMA). The Q&A catalogues, which can be used by marketing authorisation holders and applicants for centralised procedures, provide answers to possible questions at different stages of the centralised marketing authorisation application.

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" has been updated or revised to include the following points:

Chapter 1 Types of application

The question 1.11. In which exceptional cases would combination packs be acceptable in the centralised procedure, and where can I submit my request for consideration? has been revised in chapter 1.

Chapter 3 Preparing the dossier

In chapter 3 the two questions When and how to request an EMEA ASMF reference number? und 3.5.7. When and how will the full RMP be published? has been updated.

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 authorisation has been granted, also contains additions and innovations in the following passages:

Chapter 1 Typ IA Variations

In chpater 1 question 1.4. How shall I present and submit my Type IA/ IAIN Variation(s)? has been revised.

Chapter 3 Typ II Variations

Chapter 3 has also been updated. This concerns the question 3.4. Is the Co-Rapporteur involved in Type II Variations?.

Chapter 5 Grouping of Variations

In Chapter 5, question 5.4. What procedure number will be given to grouped variation applications? has been updated.

Chapter 6 Worksharing of variations

Her the question 6.3. What pre-submission steps will apply to a worksharing procedure? has been reworked.

Chapter 16 Risk Management Plan

Also in chapter 16 the question 16.14. When and how will the RMP Summary be published on the EMA website? has been revised.

Chapter 18 Article 46 paediatric study submission

In chapter 18 the question 18.1. What is the "Article 46 paediatric study submission"? has been newly outlined.

The new versions of the "Q&A" documents for centralised procedures can be found at:

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