EMA Answers Drugmakers’ Brexit Questions on Transfers and Relocations

The European Medicines Agency says marketing authorization holders must be based in the European Economic Area post-Brexit — and UK-based companies will likely need to transfer marketing authorizations to new addressees.

EU laws will cease to apply to the UK — forcing transfers of marketing and orphan designations to holders in the EEA, which includes the EU member states plus Norway, Liechtenstein and Iceland.

The UK will become a “third country” for the purposes of EU regulations, noted the EMA in the first of a series of joint guidances with the European Commission

In addition, each pharmaceutical company’s Qualified Person for Pharmacovigilance must reside and work in the EEA, and will have to relocate if they are based in the UK. Pharmacovigilance master files also must be located within the Union.