Community pharmacies in Great Britain will no longer be required by law to verify and decommission unique identifiers on prescription medicine packs as the safety elements of the EU Falsified Medicines Directive (FMD) and Delegated Regulation cease to be effective from January 1.
However, certain EU legislation will continue to have effect in Northern Ireland, according an update from the UK FMD Working Group for Community Pharmacy as the Brexit transition period ends on December 31.
The end users in Britain, including hospitals and wholesalers, 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 the New Year’s Day.
“Pharmacy contractors and IT 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,” Pharmaceutical Services Negotiating Committee (PSNC) has said in an update.
“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 December 31 for the end users in Britain.
FMD in Northern Ireland
According to the terms of the Northern Ireland Protocol, which constitute part of the UK’s Withdrawal Agreement with the EU, FMD will still apply in Northern Ireland, for at least four years.
“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,” a government release has said.
SecurMed UK will continue to provide end user registration and necessary support to enable Northern Ireland end users to decommission packs with FMD identifier features in to 2021 and beyond.
Meanwhile, 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.