EMA: Stability Data for Variation Notifications - Update to the Guideline

In December 2025, Revision 3 of the Guideline on stability testing for applications for variations to a marketing authorization was published on the EMA website. It entered into force on 15 January 2026. The new version now complies with the new requirements resulting from the updated Variations Regulation (Commission Delegated Regulation (EU) 2024/1701 of 11 March 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) and sets out the individual requirements for the stability data necessary for the submission of variation notifications.

The table of contents for Revision 3 is listed here in abbreviated form:

Executive summary
1. Introduction (background)
2. Scope
3. Legal basis
4. General requirements
5. Type I variations
6. Type II variations
  6.1. (Q.I.a.1.b)
  6.2. (Q.I.a.1.f)
  6.3. (Q.I.a.2.b)
  6.4. (Q.I.c.1.b)
  6.5. (Q.II.a.3.b.2)
  6.6. (Q.II.a.4.c)
  6.7. (Q.II.a.5)
  6.8. (Q.II.b.1.c)
  6.9. (Q.II.b.3.b)
  6.10. (Q.II.b.3.c)
  6.11. (Q.II.b.3.d)
  6.12. (Q.II.b.4.d)
  6.13. (Q.II.e.1.a.3)
  6.14. (Q.II.e.1.a.4)
  6.15. (Q.II.e.1.b.2)
  6.16. (Q.II.e.2)
  6.17. (Q.II.e.6.c)
7. Commitment batches
References
Annex I
Annex II

Compared to the previous version (Revision 2), changes and updates have mainly been made to chapters 4, 5 and 6, whereas the information in Annex I and Annex II has remained largely unchanged. In Chapter 6, 'Type II variations', for example, only 17 sub-items are listed in Revision 3, compared to 19 sub-items in the previous version. The sub-items in Chapter 6 list the respective stability data and studies required to submit variation notifications in this category.

The updated texts of the guideline can be viewed here.