The results of The European Medicines Agency Brexit preparedness survey, released in July 2018, show that the majority of Marketing Authorisation Holders (MAH’s) are taking steps to make the necessary changes to their marketing authorisations.Institutions, both public and private, are preparing for a ‘no deal’ Brexit and the possibility that the UK will ‘crash out’ of the EU on March 30th 2019. Regardless of the UK’s mode of departure they will become a ‘third country’ on that date and, as such, the EU rules relating to medicines for human and veterinary use will no longer apply. As a result of that (and as we have pointed out in previous articles) companies will need to make a number of changes as:
a) The MAH must be in the EU
b) The QPPV must be in the EU
c) The PSMF must be in the EU
d) Certain manufacturing sites must be in the EU in order for a company to market their medicine in the EU.