Update on FMD for contractors

Update on FMD for contractors

November 16, 2020

The UK FMD Working Group for Community Pharmacy has today (16th November 2020), issued an update for pharmacy contractors across the UK.

Now that the UK has left the EU and the Transition Period ends on 31st December 2020, some regulatory requirements will no longer apply. However, certain EU legislation will continue to have effect in Northern Ireland under the Northern Ireland Protocol.

Pharmacies in Great Britain

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 31st December 2020. This means that pharmacies in England 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 1st January 2021.

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.

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.

Read more about these developments, including the implications for contractors in Northern Ireland

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.

 



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