Updated version of the document “EMA post-authorisation procedural advice for users of the centralised procedure”

guidance document

Updated version of the document “EMA post-authorisation procedural advice for users of the centralised procedure”

Last week, European Medicines Agency (EMA) updated the guidance documentEuropean Medicines Agency post-authorisation procedural advice for users of the centralised procedure.

This guidance document addresses a number of issues that marketing authorisation holders (MAHs) may have on post-approval procedures and provides an overview of the Agency’s position on issues, which are often addressed in evaluations or meetings with MAHs in the post-approval phase.

The Agency regularly updates this document to reflect new developments, to include guidance on further post-approval procedures and to reflect the implementation of the new European legislation.

Asphalion has extensive experience with Centralised Procedures (CP). If you are planning a CP for Marketing Authorisation Application (MAA) or about to initiate a post-authorisation procedure for products approved through CP and would like to have support, please contact us at info@asphalion.com

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