The General Pharmaceutical Council (GPhC) said it intends to take a “pragmatic and proportionate approach” on the safety features under the Falsified Medicines Directive (FMD).
The legal requirements of the safety features Delegated Regulation under the FMD will be in force from tomorrow (9 February) onwards.
“We recognise that not all pharmacies will be meeting the legal obligations of FMD straight away. We intend to take a pragmatic and proportionate approach to the implementation of the new safety features,” said Duncan Rudkin, Chief Executive of the GPhC in joint statement issued with the Royal Pharmaceutical Society (RPS).
Chief executives of both organisations met earlier this week to discuss professional concerns around FMD implementation.
“When inspecting a pharmacy, our inspectors would consider all of the relevant evidence, including whether the pharmacy had a clear plan in place to meet all of the requirements of FMD, before deciding whether or not the relevant standard had been met,” Rudkin added.
The safety features regulation under FMD 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.
Paul Bennett, Chief Executive of the RPS, said: “We welcome the pragmatic approach taken by the GPhC in relation to FMD, which we hope will provide some assurance to our members in pharmacies that are still working towards meeting all of the requirements relating to FMD.”
The UK FMD working group for community pharmacy has issued an interim guidance on dealing with FMD alerts.