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EMA Explains How To Make Brexit-Related MA Changes, As Industry Bodies Urge Transition Period

Executive Summary

The EMA has produced further guidance for pharmaceutical companies on the changes they will need to make as a result of Brexit, focusing on activities such as transfers of marketing authorizations and orphan designations, and changes to personnel responsible for pharmacovigilance and batch recalls. Meanwhile, UK and European industry bodies say there is not enough time to make the necessary changes and that a transition period is needed.

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