EMA: Further Update of the Q&A Documents on "Centralised Procedures"

Recommendation

17/18 September 2024

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In December 2023, the "Questions & Answers (Q&A)" documents relating to centralised procedures were revised again and published on the website of the European Medicines Agency (EMA). The Q&A documents, which can be used by marketing authorisation holders and applicants for centralised procedures, provide answers to any questions that may arise at different stages of the central marketing authorisation application.

The list of questions relating to topics before and during the submission of a centralised procedure "European Medicines Agency pre-authorisation procedural advice for users of the centralised procedure" has been updated respectively revised to include the following points:

Chapter 2 Steps prior to submitting the application

The answer to the question "What is the procedure for appointment of Rapporteurs/Co-Rapporteurs and their assessment teams?" has been updated in section 2.4.1.1 Requesting the appointment of CHMP/PRAC/CAT Rapporteurs/Co-Rapporteurs and their assessment teams.

Chapter 5 Assessment of Application

In section 5.1. the following two questions and their answers have been fundamentally revised and are now presented as follows:

• 5.1.11. Can EMA assessment or inspection documents be shared with regulators outside the EU?
• 5.1.12. How can I change the applicant for an ongoing marketing authorization application?

Furthermore, in section 5.2 Inspections, the texts relating to the question 5.2.1 "When can I expect a pre-authorization GMP inspection and how are they conducted?" have been adapted in the passage 5.2.1.2 Pre-submission notification.

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

Chapter 1 Type IA Variations

In Chapter 1, the text answering the question 1.6 "Can my Type IA/ IAIN be part of worksharing?" now includes the passage "Please click on "Finance Services", then the Type of ticket request to be selected is "Request for high-level procedure or ASMF number" followed by sub-option "IG procedure number (Type IA grouping)" or "Workshare procedure number". The letter of intent should be attached to the EMA Service Desk ticket."

Chapter 16 Risk Management Plan

An addition was also made to Chapter 16 in the answer to question 16.14. "When and how will the RMP Summary be published on the EMA website?"

The new versions of the "Q&A" documents for centralised procedures can be found on the EMA website under:

• Topics before and during application
• Post-authorisation topics