Renewal and annual re-assessment of marketing authorisation

This page lists questions that marketing-authorisation holders (MAHs) may have on renewals of marketing authorisations, annual renewals of conditional marketing authorisations and annual re-assessments of marketing authorisations granted in exceptional circumstances.

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.

A PDF versions of the entire post-authorisation guidance are available:

These questions and answers have been produced for guidance only and should be read in conjunction with the rules governing medicinal products in the European Union, volume 2, notice to applicants.

MAHs must in all cases comply with the requirements of Union legislation. Provisions that extend to Iceland, Liechtenstein and Norway by virtue of the European Economic Area agreement are outlined in the relevant sections of the text.

Renewal of marketing authorisation

Annual renewal: conditional marketing authorisation

Annual re-assessment: exceptional circumstances


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