Notifying a change of marketing status

This page lists questions relating to the notification of marketing and cessation, suspension, withdrawal of a medicinal product from the market and withdrawal of a marketing authorisation. It also covers 'sunset-clause' monitoring.

The monitoring of marketing status of medicinal products aims to increase communication and transparency on availability of medicinal products across the Union and potential safety issues and to allow consideration on the need for action in different Member States or at EU level.

A PDF version of the entire post-authorisation guidance is 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 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 status updates and withdrawals

    Sunset-clause monitoring

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