Guidance issued on Falsified Medicines Directive

Long-awaited guidance has been issued to help community pharmacies understand and implement the EU Falsified Medicines Directive (FMD) as the 12-month milestone to the implementation of key provisions approaches.

The UK FMD Working Group for Community Pharmacy says that the guidance is intended to build understanding of the options open to pharmacy contractors and to “start conversations” between pharmacies and IT system suppliers. It is not a complete and final implementation plan for FMD, because many important details from the Government are still missing and each pharmacy owner will have to make their own decisions about how FMD is implemented within their own business, says the group.

‘The Way Forward for FMD in Community Pharmacy’ covers key assumptions about FMD, processes for incorporating authentication into existing dispensing workflows, handling stock transition, what IT systems will need to deliver and implications for patient safety. 

A key assumption concerning Brexit is that the UK will be considered, for the purposes of the FMD Delegated Regulation, still to be ‘inside the EU’, mirroring the UK Government’s stated aim of “high regulatory alignment” with EU medicines legislation.

Chair of the working group, NPA board member Raj Patel, said: “FMD is going to happen, and it is only a year until the kick-off date for safety features including 2D barcodes and tamper-proof seals on medicine packs. Time is short, so we must make whatever preparations we can, on the basis of the facts already available, even if these are frustratingly incomplete.

“There remains a yawning information gap and a lack of assurances about the position post-Brexit, so we are working from reasonable assumptions about the position. We see it as our duty to supply pharmacies with the best steer possible, while acknowledging that meeting the February 2019 implementation date will be heroically challenging, to say the least.

“The pharmacy sector has major investment decisions in relation to FMD which cannot be postponed for much longer. However, we can now start having conversations with each other and our suppliers, so that we are better prepared.”

  • The UK FMD Working Group for Community Pharmacy brings together all the main pharmacy bodies representing community pharmacy to influence and inform the implementation of FMD in the UK. It comprises expert representatives from NPA, AIM, CCA, PSNC, CPW, CPS and CPNI.

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