EU Publishes Updated Guideline on Variations to Marketing Authorisations

In mid-September 2025, the European Union published the revised Classification Guideline detailing procedures for variations to marketing authorisations for medicinal products for human use. The guideline will become mandatory from 15 January 2026. It updates and expands the Variations Regulation, following Commission Delegated Regulation (EU) 2024/1701, which amended Regulation (EC) No 1234/2008.

The document provides comprehensive procedural guidance on the submission and assessment of minor (Type IA and IB) and major (Type II) variations, as well as extensions, annual updates for human influenza and coronavirus vaccines, urgent safety restrictions, and compliance statements under the Paediatric Regulation.

It also addresses worksharing procedures, including submission and assessment processes for both centrally authorised and non-centrally authorised medicinal products. The guideline is structured into four chapters, with procedural guidance in Chapters 2 and 3 and an annex in Chapter 4.

The updated guideline is accessible on the EUR-Lex website, providing stakeholders with the detailed framework needed for regulatory compliance in variation submissions.

01-10-2025