How will Brexit affect the Falsified Medicines Directive and its’ processes?
Following the UK General Election of 12th December 2019 the UK Government passed the EU Withdrawal Agreement Bill, consequently the UK left the EU on 31st January 2020.
Under this arrangement the UK has entered an Implementation Period, which, under the Withdrawal Agreement, will end on 31st December 2020. During the Implementation Period the UK will continue to remain in the single market and consequently remain fully aligned to EU Law. This means that the FMD and Delegated Regulation will continue to apply to all in the UK supply chain at least until 31st December 2020, as if the UK were still a member of the EU.
The fate of UK FMD ‘Safety Features’ legislation after 31st December 2020 and therefore the requirement for a UK medicines verification organisation and system after that time will be dependent on UK/EU negotiations as to the shape of the Future Economic Partnership between the UK and EU which will progress during the Implementation Period.