EU
To prepare the UK’s withdrawal from the EU, EMA and the European Commission published the first in a series of Q&As for pharmaceutical companies on May 31st 2017. This guidance applies to pharmaceutical companies of both human and veterinary medicines and contains information on the location of establishment of a company in the context of centralized procedures and certain activities, including the location of orphan designation holders, qualified persons for pharmacovigilance (QPPVs) and companies’ manufacturing and batch release sites.
A series of further guidance documents on the consequences of Brexit will be published here.