European Commission warns UK over drug authorisation validity due to Brexit

The European Commission has issued a warning to pharmaceutical firms in the UK over the validity of current and future drug authorisations in the wake of Brexit.

In a statement, the organisation reiterated that, under EU law, it is required for any authorisation holders to be established in one of the European Union member states or an EEA country. Given the Britain’s exit from the Union and its revocation of its status as a member state, drug companies that are purely UK-based could see their product approvals disrupted.

Such companies are urged to screen authorisations which are likely to be affected by the UK’s exit in March 2019.

In the release Notice to marketing authorisation holders of centrally authorised medicinal products for human and veterinary use, the Commission noted: "Marketing authorisation holders may be required to adapt processes and to consider changes to the terms of the marketing authorisation holders may be required to adapt processes and to consider changes to the terms of the marketing authorisation in order to ensure its continuous validity and exploitation, once the United Kingdom has left the Union."

The statement continued: "In  particular,  the  Commission  and  the  European  Medicines  Agency  expect  marketing  authorisation  holders  to prepare and proactively  screen  authorisations  they  hold  for  the  need for  any changes. The necessary  transfer  or  variation  requests  will  need  to  be  submitted in  due  time  considering  the  procedural  timelines  foreseen  in  the  regulatory  framework."

Major industry associations, including the ABPI and the BioIndustry Association, have recently called for close co-operation with the next UK Government to strengthen life science prospects and to smooth the difficult transition period over the course of Brexit and beyond.