CMDh/HMA: Updated Guidance Documents on Variation Notifications

Recommendation

5/6 November 2025
Vienna, Austria

Since 01 January 2025, the "Guidance Documents" regarding 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) in the "Variations" section of the HMA (Heads of Medicines Agencies) website are to be observed.

They include the so-called "Best Practice Guides (BPGs) for the Submission and Processing of Variations in the Mutual Recognition Procedure" in addition to a large number of other documents. These guides consist of 8 chapters, which were updated in October 2024 and are listed below:

Chapter 1: CMDh BPG for the Allocation of the Mutual Recognition Variation Number for Type I Notifications, Type II Variations, Grouping and Worksharing
Chapter 2: Procedure for Automatic Validation of Mutual Recognition Procedures for Variations
Chapter 3: CMDh BPG for the Processing of Type IA Minor Variations (Notifications) in the Mutual Recognition Procedure
Chapter 4: CMDh BPG for the Processing of Type IB Minor Variations (Notifications) in the Mutual Recognition Procedure
Chapter 5: CMDh BPG for the Handling of Type II Variations in the Mutual Recognition Procedure
Chapter 6: CMDh BPG for the Processing of (Super-)Grouped Applications in the Mutual Recognition Procedure
Chapter 7: CMDh BPG on Variation Worksharing
Chapter 8: CMDh BPG on CMDh Recommendations on Unforeseen Variations

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) can be found on the HMA website.