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EMA Guidance on Post-Authorisation Procedural Advice for CAP users & EudraVigilance Reg. Manual

On 18 March 2022, EMA released updated guidance on "European Medicines Agency post-authorisation procedural advice for users of the centralised procedure".


This guidance document addresses a number of questions which marketing authorisation holders (MAHs) may have on post-authorisation procedures. It provides an overview of the Agency’s position on issues, which are typically addressed in discussions or meetings with MAHs in the post-authorization phase.

This guidance information and fruitful pre-submission dialogue between MAHs and the Agency will enable MAHs to submit applications, which are in conformity with the legal and regulatory requirements and which can be validated and processed promptly.


Click this LINK for more detailed information on Variations, Extension of marketing authorisation, Grouping, Workshatring & other information.


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