The European Medicines Agency (EMA) and the European Commission have published guidance to help pharma companies prepare for the UK’s withdrawal from the European Union. The first in a series of guides contains information around company location in the context of centralised procedures and certain activities, including the location of orphan designation holders, qualified persons for pharmacovigilance, and companies’ manufacturing and batch release sites.
The EMA will be producing a series of further documents relating to the subject of Brexit, and Boyds remains committed to supporting its clients with access to EU and regulatory procedures and guidelines.
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