UK doctors ‘could get extra year’ for FMD compliance

With just over a week to go until the Falsified Medicines Directive comes into effect, a group representing GPs in the UK has suggested it could take a year for surgeries to come into compliance.

The General Practitioners Committee (GPC) – part of the British Medical Association (BMA) – says in its latest newsletter that “we expect there to be a long lead time and that full implementation will not happen for at least 12 months,” although it adds that this is still to be confirmed.

The EU’s safety features requirements come into effect from February 9, and include visible tamper-evidence and unique barcodes on all prescription medicine packs that need to be scanned at the point of dispensing, in order to detect falsified medicines and to ensure that they are not expired or subject to a recall.

The GPC acknowledges this will have an impact on all practices, which should be preparing for implementation to demonstrate compliance with the directive, but it goes on to advise that practices should “contact their system suppliers and await their confirmation as to timescales and process.”

“We are currently waiting for further details from NHS England and these will be communicated as soon as they are available,” it adds.

GP surgeries are defined as healthcare institutions under the EU directive, so the FMD affects all practices. Complicating the picture for all parties in the UK however is the looming threat of a no-deal Brexit, which could mean that the UK is excluded from accessing the central EU repository for the medicines verification process that underpins the FMD.

The communication comes shortly after practices in three UK counties were advised by their Local Medical Committee (LMC) not to spend money on ‘expensive kit’ to comply with the FMD, until the government provides further guidance.

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