Future of the ‘safety features’ measures under FMD in Great Britain and Northern Ireland

Update from UK FMD Working Group for Community Pharmacy

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 (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 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.
  • 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.

Pharmacies in Northern Ireland

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.
  • 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.

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 operational specifics. Please check the latest guidance for industry, the first version of which was due to be published soon after the release of this document.

https://www.gov.uk/government/news/irelandnorthern-ireland-specialised-committee-05-november-2020

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.

Actions to take

Great Britain: End users should check that any integrated pharmacy systems are no longer actively connecting to or seeking a response from UKMVS from the end of 2020. Turn off or disconnect any stand-alone FMD systems after 31st December.

Northern Ireland: End users should ensure they are registered with SecurMed UK (www.securmed.org.uk), if they have not already done so. Pharmacy teams should continue to verify and decommission FMD-compliant packs of prescription medicines. Refresher training should be carried out if needed.

Q&A

How do I register for access to the UKMVS?
https://securmed.org.uk/what-do-you-want-to-do/registration-process/

How do I get help?
In the first instance please contact your Software Supplier. Check the SecurMed UK website: http://www.securmed.org.uk

Further information is available on FMD Source (fmdsource.co.uk).

The UK FMD Working Group for Community Pharmacy brings together the main pharmacy bodies representing community pharmacy to influence and inform the implementation of FMD in the UK

16.11.2020

Statement from UK FMD Working Group for Community Pharmacy

Community pharmacies must work towards compliance with the Falsified Medicines Directive (FMD) in time for February 9th deadline irrespective of any Brexit scenario, pharmacy bodies have said.

The guidance, from the UK FMD Working Group for Community Pharmacy, follows recent meetings between the regulators, the government and the Working Group itself.

In particular, it concerns the safety features Regulation under FMD that requires medicines packaging to have a unique 2D-barcode and an anti-tampering device, both of which must be checked at various points in the supply chain.

Chair of the Working Group, Raj Patel, said:

“All parties recognise the challenges around FMD and we are confident that the regulators will take a pragmatic and even-handed approach to enforcement.

“Nevertheless, pharmacies must make efforts to be compliant with the new FMD safety features, by the deadline.

“Pharmacies must act promptly, but they must also act properly to ensure they are prepared for the new FMD safety features.

“They must carefully consider the terms of any contract for FMD solutions and make sure they are futureproof in any post-Brexit scenario.

“Other practical adjustments might be required, such as modifying dispensing workflows and all pharmacies will need to update their standard operating procedures.

“However, there will be very few packs of medicines in pharmacies with the FMD safety features, on February 9th, as they will take time to come through the medicines supply system, so inevitably the sector is on a journey towards full implementation.”

From February 9th, pharmacies must check the integrity of the anti-tampering device and scan the 2D barcode to mark each pack as decommissioned (or dispensed) in the FMD database.

It is understood there will be significant quantities of medicines in the supply chain that do not carry the new safety features, after February 9th, but it can still be wholesaled and dispensed.

Pharmacies are expected to have clear standard operating procedures in place to empower individuals to make judgement calls they could later justify, rather than disrupt supply to patients.

General Pharmaceutical Council inspectors will not focus unduly on any single issue and will assess the pharmacy in the round considering the health, safety and wellbeing of patients and the public.