Brexit preparedness survey launched by EMA

The European Medicines Agency is launching a survey to gather information from companies on their Brexit preparedness plans and identify any particular concerns with regard to medicines supply that may impact public or animal health.

The EMA is consulting marketing authorization holders of centrally authorized medicines that are located in the UK, or who have quality control, batch release, and/or import manufacturing sites or a qualified person for pharmacovigilance (QPPV) or pharmacovigilance system master file (PSMF) in the UK, on their plans to submit transfers, notifications or variations to their marketing authorizations in the context of the UK’s withdrawal from the European Union.

The aim of this survey is twofold. Firstly, to identify those companies where there is a need for concerted action to address medicines supply concerns due to Brexit in order to protect human and animal health, and secondly to help the Agency and the European Commission plan resources in the areas where these submissions will be processed. Information from the survey will also be used to inform next steps in Brexit preparedness for the EMA, the European Commission and the European medicines regulatory network.