Updated Classification Guideline Published

In mid-September 2025, the updated so called Classification Guideline, entitled "Guidelines on the details of the various categories of variation, on the operation of the procedures laid down in Chapters II, IIa, III and IV of Commission Regulation (EC) No 1234/2008 concerning the examination of variations to the terms of marketing authorisations for medicinal products for human use, and on the documentation to be submitted pursuant to those procedures" was published on the European Union (EU) website. It will become mandatory from 15 January 2026. It has been revised and expanded as part of the update to the 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 authorisations for medicinal products for human use).

The revised document contains four chapters. Chapters 2 and 3 have further subchapters and passages. An overview of the table of contents is provided here:

1. INTRODUCTION  
2. PROCEDURAL GUIDANCE ON THE HANDLING OF VARIATIONS  
Submission of a variation application  
2.1.  Minor variations of Type IA
2.2.  Minor variations of Type IB
2.3.  Major variations of Type II
2.4.  Extensions
2.5.  Annual update on human influenza and human coronavirus vaccines
2.6.  Human vaccines to address a potential or recognised public health emergency in the European Union
2.7.  Urgent Safety Restrictions
2.8.  Statement of compliance under the Paediatric Regulation
3. PROCEDURAL GUIDANCE ON WORKSHARING
3.1.  Submission of variation application under worksharing
3.2.  Worksharing assessment involving products other than those under the centralised procedure
3.3.  Outcome of the worksharing assessment involving medicinal products other than those centrally authorised
3.4.  Worksharing assessment involving centrally authorised medicinal products
3.5.  Outcome of the worksharing assessment involving centrally authorised medicinal products
4. ANNEX

The updated guideline is available on the EU website under the heading 'EUR-Lex'.