EMA surveys pharma companies on their preparedness for Brexit

Planning of regulatory steps needed to ensure medicines remain on EU market

The European Medicines Agency (EMA) 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.

EMA is consulting marketing authorisation holders of centrally authorised medicines that are located in the United Kingdom (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 authorisations in the context of the UK’s withdrawal from the European Union (EU).

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