EMA Publishes Revision 3 of Guideline on Stability Testing for Variation Applications

In December 2025, the EMA released Revision 3 of the Guideline on stability testing for applications for variations to a marketing authorization, which came into force on 15 January 2026. The update aligns with the revised Variations Regulation (Commission Delegated Regulation (EU) 2024/1701) and specifies the stability data required for submitting variation notifications for medicinal products.

Key updates compared to Revision 2 focus on chapters 4, 5, and 6, while Annex I and II remain largely unchanged. Chapter 6, covering Type II variations, now lists 17 sub-items instead of 19, detailing the specific stability studies and data necessary for different variation notifications. Other sections include general requirements, Type I variations, commitment batches, and references.

The revision ensures applicants provide the appropriate stability data in compliance with the updated regulatory framework, helping streamline the evaluation of variation submissions across the EU.

03-02-2026