How will Brexit affect the Falsified Medicines Directive and its’ processes?
The current information we have on Brexit is that the UK remains a part of the EU and all rights and obligations of EU Membership remain in force until we leave.
The FMD and Delegated Regulation came into force on 09-Feb-2019 and therefore in order to satisfy their obligations, Manufacturers, Parallel Distributors and Marketing Authorisation Holders (MAHs) with POM Marketing Authorisations are obliged to fund SecurMed UK and the UK Medicines Verification System.
Full details of the MAH onboarding procedure can be found here: https://www.securmed.org.uk/mah-onboarding/
DHSC/ MHRA have confirmed that in the event of a No Deal Brexit, the FMD leglisation will be withdrawn and obliged stakeholders will no longer need to comply. Serialised medicine packs can continue to be supplied into the UK market as long as they meet MHRA local packaging requirements.