Publications

Following the amended Variations Regulation No 1234/2008 (amended by Commission Delegated Regulation (EU) 2024/1701) applicable since 1 January 2025, the European Commission has recently published a draft version of the new EC guidelines on the details of the various categories of variations and operation of the procedures. The final version is expected to be published in the EU Official Journal at the end of August and to enter into force on 15 January 2026.

Here below an overview regarding the implementation of the revised variations framework:

• A single cut-off date for the entry into application (i.e., 15 January 2026) is foreseen as set out in the draft version of the Variations Guidelines.
• Until 15 January 2026, marketing authorisation holders should continue to rely on the current Variations Guidelines and on the specific procedural guidance.
• To facilitate the transition for Type IA variations, the CMDh expects all type IA variations implemented before 15 January 2026 to be submitted in an annual update in December 2025 or before January 15, 2026 (as per the report from the CMDh meeting of 22-23 July 2025)
• Only in cases where single type IA variations are implemented after the submission of the annual update these are accepted as individual notifications (as per the report from the CMDh meeting of 22-23 July 2025

Regulatory Pharma Net offers regulatory assistance throughout the whole drug lifecycle and is also available to provide full regulatory support in the management of the transition to the new revised variations framework.