Are you ready to implement the revised variations categories guidance?

As of today (15th January 2026) they are to be used for any variation procedure submitted in the EU and UK : EU – New Variations Guidelines in the EC’s Official Journal

Regulation (EU) 2024/1701 of 11 March 2024, amending Regulation (EC) No 1234/2008 was entered into force on 7 July 2024. It became applicable on 1 January 2025. The new categories are effective from 15th January 2026.

The changes are summarised as follows:

1. This guidance no longer applies to Veterinary Medicinal Products (now governed by Regulation (EU) 2019/6)
2. The Article 5 recommendations accumulated since 2013, for changes not foreseen in the previous version of the category guidance, have all been incorporated into the new guidance.
3. The scope of changes, previously designated as A, B C and D are now replaced by E (Admin), Q (Quality), C (Safety, Efficacy & PV) and M (PMF/VAMF).
4. The latest version of the eAF (e.g. interactive pdf eAF v1.28.0.0 or PLM Portal web-based variation form January 2026 version) must be used from 15th January onwards
5. Updates to most variation categories include amendments to the conditions to be met, documentation required for submission and addition of notes to clarify when the category is most suitable 
6. Mandatory Annual Reporting requirements are added
7. Clarifications on Super-grouping are added
8. Clarifications on Work-sharing are added
9. Encouraged use of Post-Approval Change Management Protocol (PACMP) and Product Lifecycle Management (PLCM) 

Remember:

• Where a variation is considered unclassified, a detailed justification for its submission as a minor variation of Type IB (or major variation of Type II, when requested by MAH) must be included.
• Where a proposed variation is not considered/classified as a minor variation of Type IB and the relevant authority/agency is of the opinion that it may have a significant impact on the quality, safety or efficacy of the medicinal product, the holder shall be informed immediately. In such cases, the holder will be asked to amend their application and to complete it in accordance with the requirements for a major variation of Type II. Once the valid revised variation application has been received, a major variation of Type II assessment procedure is initiated
• Where the same variation of Type IB/Type II affects several marketing authorisations owned by the same holder, the holder must submit these variations as a single application for worksharing. If a submission has been made as one or several variations but not including all affected marketing authorisations owned by the same holder in a single application as worksharing, the holder shall amend their application.
• This Annex does not deal to the classification of extensions, which are exhaustively listed in Annex I of the Variations Regulation. All changes set out in Annex I of the Variations Regulation must be considered extensions of the marketing authorisations

The EU guidance will also apply for the UK and the MHRA want MA Holders to provide also a contents page included with the submission, listing all documents included in the eCTD sequence.

If you would like to discuss any of the above and if you need support for any of your Variation applications we are ready to assist you and your team.

Feel free to contact us and we will be happy to help.

Written by Alice D’Alton