HMA/CMDh: Update to the Best Practice Guides on Variations

In December 2025, updated documents on the topic "Variations" were published on the HMA/CMDh website. These include, for example, Chapter 7 "CMDh BPG on Variation Worksharing" of the "Best Practice Guides (BPGs) for the Submission and Processing of Variations in the Mutual Recognition Procedure" and the "EMA/CMDh Explanatory notes on Variation Application Form - Human medicinal products only." In both documents, the changes and updates are highlighted and relate primarily to the new requirements resulting from the updated "Variations Regulation" (Commission Delegated Regulation (EU) 2024/1701 of March 11, 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).

Chapter 7 CMDh BPG on Variation Worksharing

In addition to formal adjustments, the updates refer to subchapter 6.1 Submission and documentation requirements, which belongs to chapter 6. The Procedure. The changes explain how products can be mentioned in the "electronic application form (eAF)" in the section "Products concerned by this application."

EMA/CMDh Explanatory notes on Variation Application Form - Human medicinal products only

This document has been fundamentally revised and is now in version 12, in line with the new requirements of the EC directives. It compares and explains the terms "grouped application," "super-grouped application," and "worksharing application." As a result, only Chapter 4 has not been changed or updated. All other chapters and sections, on the other hand, contain updates and new information or show new schematic representations or example illustrations.

The new versions of the above-mentioned documents can be found on the HMA/CMDh website - revised and with change tracking.