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FMD

MHRA confirms it will consider UK version of Falsified Medicines Directive

With less than a month until the Falsified Medicines Directive (FMD) is implemented on 9 February 2019, the Medicines and Healthcare products Regulatory Agency (MHRA) has confirmed that if there is a no-deal Brexit it will consider a UK-only version of the EU law.

In a government response to a 2018 consulation on the implementation of ‘safety features’ under the FMD, the MHRA said that “in the interests of public safety, we will evaluate the options around a future national falsified medicines framework”.

The statement, published on 24 December 2018, supports what Claymore Richardson, senior policy manager at the Department of Health and Social Care, told delegates at the Pharmacy Show in October 2018. Richardson told delegates that it would be “common sense” to build on work already done to create a UK version of FMD legislation in the case of a no-deal Brexit.

If the UK leaves the EU without a deal, access to the EU database — including the European Medicines Verification System (EMVS), which is the heart of FMD compliance — will be revoked. The MHRA had previously said that since FMD compliance is impossible without access to the EMVS, legal obligation to adhere to FMD regulations “would be removed for actors in the UK supply chain” in the event of a no-deal departure.

Some pharmacies in the UK are already FMD compliant: on 11 November 2018, a pack of insulin was thought to be the first medicine to be decommissioned under FMD procedures at Aintree University Hospital NHS Foundation Trust. Shortly afterwards, Market Pharmacy in Bolton was thought to be the first UK community pharmacy to decommission a medicine.

The National Pharmacy Association has advised pharmacists to prepare themselves for FMD but to “avoid signing long-term contracts” with FMD solution providers.

Citation: The Pharmaceutical Journal DOI: 10.1211/PJ.2019.20206001

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