EU Exit and UK MVS
Following the formal departure of the United Kingdom (UK) from the European Union (EU) on 31st
January 2020, the UK entered into a Transition Period lasting until 31st December 2020. During the
Transition Period the UK will continue to remain in the single market and consequently remain fully
aligned to EU Law. This means that the Falsified Medicines Directive (FMD) and associated
Delegated Regulation (DR) 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.
At the end of the Transition Period, the UK becomes a third country in relation to the EU. Unless a
negotiated outcome provides that the EU pharmaceutical regulatory framework applies to the UK,
the UK legislation relating to the FMD and associated DR will be revoked by the UK government as
of 1st January 2021 for England, Scotland, Wales, Channel Islands and Isle of Man, as UK supply
chain stakeholders would no longer be able to consistently comply with the established EU wide
rules and requirement. Under the Northern Ireland Protocol of the EU Withdrawal Agreement, the
EU pharmaceutical regulatory framework will continue to apply in Northern Ireland including FMD.
SecurMed UK and its stakeholders are planning and considering the options for the future
arrangements for medicines serialisation in the UK countries (except Northern Ireland). One
OPTION may involve the disconnection of the UK Medicines Verification System (UK MVS) from the
EU-Hub and disconnection of end-users (Community Pharmacy, Wholesalers, Hospitals, GPs/Health
Centres and Clinics) in scope of FMD, except those end users in Northern Ireland.
SecurMed UK is aware that this would fall during the busy Winter Period and is providing advance
notice of a possible scenario so that there is no impact to medicines distribution, end-user
operations and medicines supply to patients as a result.