Europe – Changing the labelling and package leaflet (Article 61(3) notifications) : Update

This page lists questions that marketing-authorisation holders (MAHs) may have on Article-61(3) notifications. It provides an overview of the European Medicines Agency’s position on issues that are typically addressed in discussions or meetings with MAHs in the post-authorisation phase. Revised topics are marked ‘New’ or ‘Rev.’ upon publication…