The EMA has produced further guidance for pharmaceutical companies on the changes they will need to make as a result of Brexit, focusing on activities such as transfers of marketing authorizations and orphan designations, and changes to personnel responsible for pharmacovigilance and batch recalls. Meanwhile, UK and European industry bodies say there is not enough time to make the necessary changes and that a transition period is needed.

As the Brexit negotiations continue, the pharmaceutical industry is anxious to have a cut-off date when it should start taking action to deal with the legal repercussions of the UK becoming a third country within the context of the EU medicines network. There are no clear answers yet, and companies are being asked to continue to wait and watch.

The EU medicines network has issued a long list of changes that drug companies with activities in the UK will have to make if they are to continue to be located from a regulatory standpoint in the European Economic Area following Brexit. Aspects affected include the location of orphan designation holders, qualified persons for pharmacovigilance, companies’ manufacturing and batch release sites and maintenance of SME status.