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.

Roles of the regulators as FMD comes into force: GPhC & MHRA statement

The MHRA and General Pharmaceutical Council (GPhC) have today (17th January 2019) published a joint statement on their respective roles in relation to the enforcement of the FMD legislation in England, Scotland and Wales.

The GPhC will use its existing inspection processes to assess whether pharmacies are meeting its standards. For those registered pharmacies that are found not to have met the standards for registered pharmacies, and where a contributing factor relates to breaches of the new safety feature provisions, the GPhC will use its regulatory powers, including improvement action plans, to make sure that pharmacies take action to meet the standards and requirements under legislation.

The MHRA is responsible for making decisions on and instigating any enforcement action in relation to the safety features legislation, which may include seeking compliance, enforcement notices or, as a last resort, criminal prosecution for the most serious, persistent breaches.

The GPhC and the MHRA will share information, as appropriate, to ensure that the purpose of the legislation is met and that medicines supplied from registered pharmacies are safe for the public to use.

Read the full joint statement