EMA: Changes to Handling of Variations

Recommendation
14/15 October 2025
With updates on the CEP 2.0!
Because of the ongoing reorganisation of the European Medicines Agency (EMA), new operating procedures will apply for:
- Type IA and IB variations;
- Type II variations;
- Periodic Safety Update Reports (PSURs);
- Administrative procedures such as transfers, 61(3) notifications and corrigenda.
The overall processes remain unchanged, but new contact persons will be assigned. Applicants will be informed directly when their contact person will change.
What is the reason for this?
As part of the new operating model, EMA is revising the existing product team lead concept and replacing it with two new roles:
Procedure Manager
Oversees all aspects of the management of specific procedures. They are responsible for managing the regulatory process surrounding each application and provide guidance on regulatory procedural matters. Procedure Managers will be the primary contact point for applicants and experts from the national competent authorities.
EMA Product Lead (EPL)
Maintains oversight of a medicine throughout the different stages of its lifecycle. They are responsible for the overall knowledge about a medicine providing regulatory science input to EMA's scientific committees when needed.
Source: EMA press release
Related GMP News
30.06.2025ICH M4Q Guideline Updated
04.06.2025EDQM: Update of Guideline "How to read a CEP"
16.04.2025EMA: Revised IRIS Documents
09.04.2025Centralised Procedures: Q&As Updated
12.03.2025CMDh/HMA: Guidance Documents on Variation Notifications Updated
11.03.2025EMA: Renewal of Q&A Document for "Centralized Procedures"