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.
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.
Posted by Dr. Tim Sandle