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Pharmacy regulators likely to be 'pragmatic' when inspecting for FMD compliance

The UK Falsified Medicines Directive (FMD) Working Group for Community Pharmacy has reassured pharmacists that regulatory inspections “will not focus unduly on any single issue” after the General Pharmaceutical Council (GPhC) said pharmacy inspections will include FMD compliance.

The working group said in a statement on 29 January 2019 that the inspections will assess the pharmacy’s processes “in the round”, focusing on the “health, safety and wellbeing of patients and the public”.

Raj Patel, chair of the working group, which comprises members from seven national bodies representing community pharmacy, said: “All parties recognise the challenges around the FMD and we are confident that the regulators will take a pragmatic and even-handed approach to enforcement.”

But the group emphasised that pharmacists must, nonetheless, work towards compliance with the FMD in time for the directive’s final implementation on 9 February 2019.

“Pharmacies must act promptly, but they must also act properly to ensure they are prepared for the new FMD safety features,” Patel said. “They must carefully consider the terms of any contract for FMD solutions and make sure they are futureproof in any post-Brexit scenario.”

In the event of a no-deal Brexit, the UK would lose access to EU databases, including the European Medicines Verification System, which is at the heart of FMD.

Owing to the current uncertainty, the National Pharmacy Association has said that pharmacists should prepare for FMD but “avoid signing long-term contracts” with FMD solution providers.

Patel added that, although the implementation date is approaching, pharmacists are not likely to see many medicine packs with the FMD safety features on that first day on 9 February 2019, adding that the new packs “will take time to come through the medicines supply chain”.

Citation: The Pharmaceutical Journal DOI: 10.1211/PJ.2019.20206073

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