EMA has published its updated “Classification of changes” guidance (Nov 2025) the procedural framework for classifying and submitting variations to marketing authorisations for medicinal products in the European Union.
This guidance governs how companies should manage post-authorization changes whether minor, moderate or major including changes to manufacturing, quality, packaging, clinical data, approval scope, and more.
📘 Guidance document link:
https://lnkd.in/ebqPbhXQ