GB ‘will disconnect from EU medicines verification on Dec 31’

Pharmacies in Great Britain will be disconnected automatically from the UK National Medicines Verification System (NMVS) on December 31, after the Brexit transition period ends.

That’s the position of the UK FMD Working Group for Community Pharmacy, which confirmed that  the safety features requirements of the Falsified Medicines Directive (FMD) will no longer apply in England, Scotland and Wales from that date – although Northern Ireland will stay connected for an additional year.

That divergence within the UK in the FMD requirements is causing concerns that it could disrupt trade in medicines across the Irish Sea.

This means that it will no longer be possible to verify and authenticate packs from January 1, 2021, according to a statement from the working group issued by UK National medicines Verification organisation (NMVO) SecurMed UK.

“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,” it says, adding that stand-alone FMD systems “can simply be turned off.”

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, according to the statement, but 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, and in the meantime, the Medicines and Medical Devices Bill (MMDB)  currently progressing through parliament – will enable the UK to develop its own regulations to help prevent falsified medicines from entering the medicine supply chain.

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That 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, according to SecurMed.

The MMDB was first introduced into the House of Commons on February 13, before being passed onto the House of Lords in June.

The Royal Pharmaceutical Society (RPS) waned last month that the UK could see “an influx of counterfeit medicines” after the FMD ceases to apply at the end of the Brexit transition.

“It is unacceptable that in the final months of the Brexit transition period, robust plans have not been put in place to prevent falsified or counterfeit medicines entering the UK,” said RPS President, Sandra Gidley.

“With 45m packs of medicines moving between the UK and the EU every month, this is a critical issue for patient safety in the UK and every European country,” she added.

The RPS wants to see technical agreements with the EU to provide continuity for the provisions of the FMD, allowing connectivity between the UK and Europe to continue.