EMA issues guidance document in preparation for Brexit
The European Medicines Agency (EMA) and the European Commission have published guidance to help pharmaceutical companies prepare for the United Kingdom’s withdrawal from the European Union.
First of a series on Brexit guidance
The question-and-answer document 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 (QPPVs), and companies’ manufacturing and batch release sites. EMA is preparing a series of further guidance documents relating to the subject of Brexit that will be published on its website in due course.
Companies are advised to regularly check EMA’s webpage dedicated to the consequences of Brexit.