Marketing and cessation notification: questions and answers
This page lists questions that marketing-authorisation holders (MAHs) may have on marketing and cessation notification. 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.
The page only focuses on marketing and cessation information and does not address the requirements to provide in the context of pharmacovigilance, the volume of sales or the volume of prescriptions. For information on these processes, see Questions and answers on the application of the so-called 'sunset clause' to centrally authorised medicinal products .
The MAH's obligations for withdrawal of either a pharmaceutical form or strength of a medicinal product in at least one Member State are addressed in Withdrawals and cessation of centrally and nationally authorised medicines: questions and answers.
A PDF version of the entire post-authorisation guidance is available:
- European 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.