EMA post-authorisation procedural advice for users of the centralised procedure – tracked changes (updated December 2025)

11th December 2025

EMA post-authorisation procedural advice for users of the centralised procedure – tracked changes (updated December 2025)

Summary (focusing on key updates):
The tracked-changes version reflects a comprehensive revision of the Q&A guidance that MAHs use to navigate post-authorisation procedures. The document covers processes such as variations, extensions, grouping and worksharing, classification of changes, risk-management plans, safety reporting, and transfers of marketing authorisation — and shows where content has been revised, added or reworded to align with recent regulatory practice and legislation. 

Notable areas with recent updates marked “Rev. Nov 2025” or similar include:

• Type IA, IB and II variations — multiple questions on submission format, timing, grouping, involvement of rapporteurs and product information updates were revised to reflect procedural clarity and recent EMA practice. 

• Extension of marketing authorisation — updated guidance on how to present and submit extension applications, timelines and paediatric considerations. 

• Grouping of variations and worksharing — several revisions clarify acceptable groupings and procedural handling (e.g. timetables and outcomes).

• Classification of changes — updated classification categories and definitions to reflect current regulatory expectations.

• Changing the (Invented) Name — revised Q&As on how to apply for name changes and required documentation. 

Additionally, many of the updated topics are marked within the tracked changes itself by EMA, showing recent revision dates (e.g., Nov 2025) against specific Q&A entries. This helps stakeholders quickly identify what has changed since the last version. 

Link: EMA post-authorisation procedural advice for users of the centralised procedure – tracked changes PDF

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