FMD and Brexit

The serialisation and authentication requirements of the EU Falsified Medicines Directive (FMD) came into force on 9 February 2019. The UK is still subject to EU regulations during the post-Brexit transition period which will run until at least 31st December 2020.

The General Pharmaceutical Council has stated it will take action if pharmacies “blatantly disregard FMD”.

Negotiations on the UK’s future relationship with the EU, which are due to take place during 2020, will determine whether FMD still applies within the UK in the future.

There is a strong likelihood that the UK government will introduce its own version of FMD, should the European directive no longer apply. We do not expect any clarity on the long-term future of FMD until the second half of 2020 at the earliest.