This week’s FMD deadline not ‘cliff edge’, GPhC reassures pharmacies
Saturday’s deadline to comply with the EU’s medicines scanning law should not be viewed as a “cliff edge”, the regulator has reassured pharmacies.
The Falsified Medicines Directive (FMD) requires all UK pharmacies to be able to scan barcodes and check tamper-proof devices on medicines packaging at the point of dispensing from February 9.
The General Pharmaceutical Council (GPhC) confirmed last month that checking pharmacies are compliant with the FMD will form part of its pharmacy inspections, and it will “use its regulatory powers, including improvement action plans, to ensure pharmacies take action” if they are found to be noncompliant.
However, it clarified last week (January 29) that while it will be checking whether pharmacies are compliant, it does “not see the implementation date of February 9 as being a ‘cliff edge’”.
Director of inspections, insight and intelligence Claire Bryce-Smith said: “If during an inspection in the following months we identified a pharmacy that was not meeting all of the requirements relating to FMD, we would be looking to understand the reasons why and seeking evidence that there was a clear plan in place.”
MHRA wants to help stakeholders comply
The Medicines and Healthcare products Regulatory Agency (MHRA) told C+D this week that it intends to “work with stakeholders to help them achieve compliance”.
It confirmed the position set out in its response to the government consultation on the FMD: that newly introduced “statutory enforcement notices” will be issued to pharmacies in breach of the FMD before considering “criminal proceedings” – which would only happen “as a last resort”.
C+D also exclusively revealed last week that the “majority” of Boots branches, as well as some Lloydspharmacy and Rowlands stores, will miss next week's FMD deadline.