Centralised Procedures: Update of the Q&A Document

Recommendation

23-25 April 2024
Barcelona, Spain

Global Registration and Life Cycle Management for APIs

In March 2022, the European Medicines Agency (EMA) published on its website the updated and revised version of the "Questions & Answers (Q&A)" document "European Medicines Agency post-authorisation procedural advice for users of the centralised procedure". These Q&As are intended to provide assistance and guidance to marketing authorisation holders and applicants of centralised procedures and to provide answers to possible questions related to post-authorisation issues. This includes, for example, explanations on how to deal with variation procedures or marketing authorisation extensions.

Updates in March 2022

Amendments and updates made in March 2022 concern the following paragraphs and headings:

• Paragraph   1.4. How shall I present and submit my Type IA/ IAIN Variation(s)? 
• Paragraph   2.4. How shall I present and submit my Type IB Variation? 
• Paragraphs 3.16., 3.26. and 3.27. Type II variations 
• Paragraph   4.15. When do I have to submit revised product information? In all languages? 
• Paragraphs 6.4., 6.5. and 6.8. Worksharing of variations 
• Paragraph   7.2.15. How should I submit a new manufacturing site for the assembly of an integral medical devices? Which variation classification category is European Medicines Agency post-authorisation procedural advice for users of the centralised procedure applicable and what type of supporting documentation is expected? 
• Paragraphs 8.1. and 8.2. Pre-submission queries service

New passages have been added to paragraphs 3 and 7.

Question 3.27.

This includes question 3.27. Whom should I contact if I have a pre-submission question when preparing my type II variation application (non-clinical/clinical/RMP)? This explains how to proceed if the Q&A documents do not provide the answers to potential Type II variation submission questions. It is requested to contact the "EMA Service Desk" with the question, the type of question and the corresponding sub-criterion, in this case "Post-Authorisation queries" and "Variation II scopes (Non clin/Clin/RMP)". A feedback from the authority will then be provided by the relevant department within the next 10 working days.

Question 7.2.15.

Paragraph 7.2.15. has also been added: How should I submit a new manufacturing site for the assembly of an integral medical device? Which variation classification category is European Medicines Agency post-authorisation procedural advice for users of the centralised procedure applicable and what type of supporting documentation is expected? This states that it must be clearly indicated which manufacturing site currently is responsible for this activity and which manufacturing site will manage it in the future. In addition, the following documents must be submitted:

• An MIA/GMP certificate(s) for secondary packaging activities
• A description of the manufacturing steps that will be performed, including critical process parameters and in-process controls, process validation and batch data (if available)

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

• Post-approval issues

For the updates and revisions made in February please see EMA: Renewed Update of the Q&A Documents on "Centralised Procedures".