Regulatory guidance for industry to prepare for the UK’s withdrawal from the EU

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31/05/2017

Regulatory guidance for industry to prepare for the UK’s withdrawal from the EU

EMA and the European Commission publish first in a series of Q&As for companies

The European Medicines Agency (EMA) and the European Commission have published guidance to help pharmaceutical companies to prepare for the United Kingdom's withdrawal from the European Union. The guidance relates to both human and veterinary medicines.

The questions-and–answers document concerns information related to the location of establishment of a company in the context of centralised procedures and certain activities, including the location of orphan designation holders, qualified persons for pharmacovigilance (QPPVs) and companies’ manufacturing and batch release sites.

EMA is preparing a series of further guidance documents which will be published on its website in due course. Companies are advised to regularly check EMA’s dedicated webpage on the consequences of Brexit.

This first questions-and-answers document follows the publication of the European Commission/EMA notice to marketing authorisation holders of centrally authorised medicines for human and veterinary use on 2 May 2017.

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