Community pharmacies using Falsified Medicines Directive (FMD) systems should ‘turn off’ FMD equipment after 31 December 2020 – the date on which the UK completes the transition period following its withdrawal from the EU.
End users are asked to check that any integrated pharmacy systems are no longer actively connecting to or seeking a response from UKMVS from the end of 2020, the UK FMD Working Group for Community Pharmacy has advised.
The ‘safety features’ elements of the EU Falsified Medicines Directive (FMD, 2011/62/EU) and Delegated Regulation (2016/161) cease to have effect in Great Britain from Thursday 31 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.
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 1 January 2021.
Integrated pharmacy systems can still use batch details, expiry dates or product details (GTINs) from packs’ 2D barcodes while these packs are still in circulation. However, pack serial numbers no longer have any function. These packs remain valid and can be dispensed for as long as they are still in date.
SecurMed UK will continue to provide end user registration and necessary support up to 31st December 2020 for end users in Great Britain.
The FMD will still apply in Northern Ireland, for at least four years (until the NI Protocol is due to be reviewed).
Future national falsified medicines system
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 enables 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. carried out if needed.