Notifying a change of marketing status

This page lists questions relating to the notifcation of marketing and cessation, suspension, withdrawal of a medicinal product from the market and withdrawal of a marketing authorisation, in the context of the implementation of Directive 2012/26/EU and Regulation (EU) No 1027/2012 amending the pharmaceutical legislation with respect to pharmacovigilance. It also covers 'sunset-clause' monitoring.

The aim of these amendments is to strengthen the European system for the monitoring of safe and effective use of medicinal products including communication and transparency on potential safety issues and to allow consideration of the need for action in different Member States or at EU level. Revised topics are marked 'New' or 'Rev.' upon publication.

A PDF version of the entire post-authorisation guidance is available:

PDF iconEuropean Medicines Agency post-authorisation procedural advice for users of the centralised procedure

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 Community 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.

See also:

Marketing and cessation notification

Withdrawn-product notification

Sunset-clause monitoring

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