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.
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