The UK triggered Article 50 of the Treaty on European Union on 29th of March 2017 and as a result all primary and secondary law ceases to apply to the UK from 30th of March 2019.

Companies who hold centrally authorised “MA s” must proactively review their MA terms, submit any  required variations  and ensure that their processes and controlled documents are updated in plenty of time for the pending exit of The UK from the EU to ensure continuity of supply.

EU law requires that pharmacovigilance and batch release etc. must be performed in the EU or EEA and that MA holders are established in the EU or EEA.

The European Medicines Agency has a useful page on its website which contains helpful information.