Falsified medicines directive to end due to Brexit

Now that the UK has left the European Union and the Transition Period ends on 31st December 2020, the regulatory requirements surrounding the Falsified Medicines Directive will no longer apply in ‘Great Britain’.

In a statement this week the UK FMD Working Group for Community Pharmacy said that the ‘safety features’ elements of the EU Falsified Medicines Directive and Delegated Regulation cease to have effect in ‘Great Britain’ from 31st December 2020.

This means that pharmacies, and other end-users such as wholesalers, hospitals and others handling or supplying medicines, will no longer be required by law to verify and decommission unique identifiers on prescription medicine packs.

European Union legislation will continue to have effect in Northern Ireland under the Northern Ireland Protocol.

In a statement released this week by the UK FMD Working Group for Community Pharmacy they commented:

“End users in Great Britain will be disconnected automatically from the UK National Medicines Verification System (UKMVS) run by SecurMed UK. This means that it will no longer be possible to verify and authenticate packs from 1st January 2021. Pharmacy operators and system suppliers need to check that any integrated pharmacy systems with FMD functions are no longer actively connecting to or seeking a response from the UKMVS after the end of 2020. Stand-alone FMD systems can simply be turned off.

“Under the terms of the Northern Ireland Protocol, part of the UK’s Withdrawal Agreement with the EU, FMD will still apply in Northern Ireland, for at least four years until the NI Protocol is due to be reviewed.

“End users in Northern Ireland will remain connected to the UKMVS. They need to continue to verify and decommission any packs with the FMD safety features (unique identifiers and anti-tamper devices) in line with the requirements of relevant EU and UK medicines legislation.

“The UK participated in discussions with the EU to agree a phased implementation of medicines regulations in Northern Ireland, under the NI Protocol, by 1 Jan 2022. The UK published a statement, agreed with the EU, on 5 Nov 2020 confirming a 12-month phased implementation of the Falsified Medicines Directive and regulatory importation requirements for medicines moving from GB to NI.

“Work is continuing with the EU to agree on operational specifics.

“The Medicines and Medical Devices Bill (progressing through Parliament) would enable the Government to make regulations aimed at preventing falsified medicines from entering the medicine supply chain. This could include establishing a national system based on the unique identification of individual packs that enable medicines to be authenticated and identified if tampered with. The Government will have to consult with industry stakeholders, including pharmacy organisations, before introducing any new Regulations. No timetable has been set by the Government for consultation.”