CMDh/HMA: Guidance Documents on Variation Notifications Updated
Recommendation
19/20 March 2025
Barcelona, Spain
Applying for and maintaining marketing authorisations: What you need to know from a GMP perspective
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On the website of the HMA (Heads of Medicines Agencies), under the heading "Variations", you will find the "Guidance Documents" relating to the updated "Variation Regulation" (Commission Delegated Regulation (EU) 2024/1701 of 11 March 2024 amending Regulation (EC) No 1234/2008 as regards the examination of variations to the terms of marketing authorizations for medicinal products for human use).
Amongst a large number of other documents, these include the so-called "Best Practice Guides (BPGs) for the Submission and Processing of Variations in the Mutual Recognition Procedure". These consist of 8 chapters, which were last updated in October 2024. Chapters 3 and 6 were revised again in January 2025:
Chapter 3: CMDh BPG for the Processing of Type IA Minor Variations (Notifications) in the Mutual Recognition Procedure
Updates have been made to subsection 1. Introduction and Annex II.
Chapter 6: CMDh BPG for the Processing of (Super-)Grouped Applications in the Mutual Recognition Procedure
Chapter 6 contains changes in the subsections 2. Application, 4. Validation of the application and 6. Finalisation of Procedures as well as in the appendices Annex I and Annex II.
The "Best Practice Guides (BPGs) for the Submission and Processing of Variations in the Mutual Recognition Procedure" and many other helpful documents (with and without change tracking) are available on the HMA website.
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