EMA revises Q&A Documents on the Topic of "Centralised Procedures"

Recommendation

10/11 October 2023
Vienna, Austria

Handling Changes and Variations

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:

Chapter 1 Types of applications and applicants

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.

Chapter 3 Preparing the dossier

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 3.4.3.6. 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.

Chapter 4 Submission, validation and fees

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:

• 3.7.     How shall I present my type II Variation application? 
• 3.8.     How shall I present my application for a new or modified therapeutic indication? 
• 4.5.     How shall I present my Extension Application? 
• 15.8.   When shall I submit my PAM? 
• 23.4.   What information should be reported to the Agency on the marketing status of CAPs? 
• 23.9.   How should I request the withdrawal of my central marketing authorisation? 
• 23.11. Which information does the Agency publish about the marketing status of EU medicinal products? 
• 24.7.   How to request an exemption to sunset clause provision for centrally-authorised products? 

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

• Topics before and during application
  
• Topics after the granting of authorisation