European Medicines Agency produces Q&A document on impact of Brexit for MA holders
24 July 2017
As the UK prepares to leave the EU, the holders of marketing authorisations for human or veterinary centrally approved need to ensure that that they take appropriate steps to ensure that they comply with the establishment requirements in the EU/EEA.
The European Medicines Agency (EMA) has provided a Q&A document highlighting some of the problems and potential solutions MA holders will need to deal with prior to the UK leaving the EU.
MA holders will need to transfer any MAs held by UK companies to a company based in the EU/EEA. The residence details for the Qualified Person will also need to be within the EU/EEA, as will the Pharmacovigilance System Master File.
Any API manufactured in the UK, after Brexit, will be considered an imported substance and will need to meet current EU GMP requirements. For products finished in the UK, MA holders will need to specify an authorised importer within the EU/EEA and specify a batch control site in the EU/EEA
A decision on the new location of the EMA is expected in November 2017.
A copy of the Q&A document is here.
With an actual "Brexit" unlikely to be before 2018, there will be both long and short term implications for UK and international businesses.