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Falsified Medicines Directive

Bolton pharmacy claims to be first in UK to become FMD compliant

The owner of Market Pharmacy in Bolton wanted to start working to the Falsified Medicines Directive earlier than its February 2019 compliance deadline to “uncover implementation problems and resolve them ahead of time”. 

FMD security features

Source: Jonathan Buisson

The Falsified Medicines Directive will attempt to limit counterfeit medicines entering the supply chain with the use of physical and digital security features

A pharmacy in Bolton is believed to be the first in the UK to become fully compliant with the requirements of the Falsified Medicines Directive (FMD).

Market Pharmacy in Bolton, part of the Hollowood Chemists group, connected to the UK Medicines Verification System (MVS) last week, according to the National Pharmacy Association (NPA). The pharmacy said that it has successfully decommissioned and recommissioned a medicine, and believes it is the first in the UK to do so. 

Hollowood Chemists is owned by NPA board member Raj Patel, a director of SecurMed UK and chair of the UK FMD Working Group for Community Pharmacy, which has members from seven UK community pharmacy bodies including the NPA and the Pharmaceutical Service Negotiating Committee (PSNC).

“There’s no need to wait until the FMD compliance deadline in February”, Patel said. “My pharmacies wanted to make a start now, to uncover any implementation problems and resolve them ahead of time.

“I’m pleased to say that everything went smoothly.”

The cost of becoming FMD-compliant is a concern for many community pharmacists. The PSNC is currently assessing the potential costs for pharmacy contractors, and Alastair Buxton, head of NHS Services at the PSNC, has said that the committee will “work to ensure that contractors’ FMD-related costs are recognised in future NHS funding settlements”.

The NPA has said that it is unclear whether the UK will retain the FMD after Brexit and, as such, has advised pharmacists to “avoid signing long-term contracts” with FMD solution providers.

Under a ‘no-deal’ Brexit, the UK’s access to the European Medicines Verification System — the central EU database that will store details of FMD-compliant medicine packs — is likely to be revoked. To further complicate matters, the Association of the British Pharmaceutical Industry and the UK Bioindustry Association recently warned that MHRA draft proposals on contingency plans for a no-deal scenario could increase the risk of falsified medicines entering both the UK and EU.

But Gareth Jones, head of corporate affairs at the NPA, said that “with the clock ticking, we are advising members to start planning now and not to delay preparations.

“While Brexit creates uncertainty it won’t stop FMD becoming an obligation from 9 February”.

The UK MVS is provided by SecurMed UK, a not-for-profit company set up to establish the UK MVS. Pharmacies in the UK have been able to register with the UK MVS since 1 November 2018.

 

Citation: The Pharmaceutical Journal DOI: 10.1211/PJ.2018.20205862

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