EMA publish practical guidance related to Brexit for marketing authorisation holders

On the 24th November 2017, the European Medicines Agency (EMA) published additional practical guidance for procedures related to Brexit for medicinal products for human and veterinary use within the framework of the centralised procedure.

The information is for marketing authorisation holders (MAHs) of centrally authorised medicinal products for human and veterinary use to consider the necessary changes and certain legal consequences that must be considered before the 30th March 2019 when the United Kingdom will become a third country unless indicated otherwise in the guidance.

The guidance, drafted jointly by the European Commission and EMA, is meant to complement the list of Questions and Answers (Q&As) available on the EMA website to provide procedural and practical guidance regarding submission of changes and related fees.

The guidance can be found here.

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Published 25. November 2017 in News EU, News UK