Additional EMA/HTA Guidance on implementation of the revised Variations process.

Date

December 3, 2025

Category

EU Regulations, UK Regulations

Description

On 22 September 2025 the European Commission published new Variations Guidelines. These guidelines will apply to variation applications submitted by marketing authorisation holders to EMA from 15 January 2026.

To assist marketing authorisation holders with the implementation of the new Variation Guidelines, EMA and HMA have published updated and new procedural guidance on 25 November 2025.  Details on the additional new variations guidance are available at Heads of Medicines Agencies: Revised Variations Framework  This guidance outlines important information for companies including:

• Regulatory and procedural information on managing variations under the new classification system; and
• How to make appropriate use of additional regulatory tools, such as the post-approval change management protocol (PACMP) and the product lifecycle management document (PLCM).

To accompany the new requirements, an updated variation application form has also been posted (version 1.28.0.0).  It must be used from 15 January 2026 and is accessible from: eSubmission: eAF

NOTE: On 17 October 2025 the UK MHRA stated that they would also be adopting the new EU Variations guidance from 15 January 2026 .