Falsified Medicines Directive will be implemented on February 9th 2019. New guidance sets out way forward for community pharmacy .
With the imminent introduction of the EU Falsified Medicines Directive (FMD), regardless of what may or may not happen with Brexit, a group made up of pharmacy leaders have provided some helpful advice and guidance to help community pharmacies understand and comply with the EU Falsified Medicines Directive (FMD). Already the 12-month milestone to the implementation of key provisions is approaching.
The UK FMD Working Group for Community Pharmacy states that the guidance will hopefully cover the options available to pharmacy contractors, give a better understanding and help start discussions with their IT system providers. There are still many significant details missing from the Government so it is not a complete implementation plan for FMD and regardless, pharmacy owners will have to make their own decisions based on a number of factors and what is best for their business but it is still a good support service in a sometime unclear area.
The Way Forward for FMD in Community Pharmacy covers the important assumptions about FMD, the high level processes for incorporating security and authentication in to your existing dispensing workflows, handling your stock transition, what your IT systems will need to provide, handle and the impact on patient safety. A key assumption is that the UK will be considered, for the purposes of the FMD Delegated Regulation, still to be ‘inside the EU’ whatever the Brexit process presents, mirroring the UK Government’s stated aim of “high regulatory alignment” with EU medicines legislation.
The Chair of the working group, NPA Board member Raj Patel MBE, said:
“FMD is going to happen, and it’s 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.”
FMD source www.fmdsource.co.uk is run by the UK FMD Working Group for Community Pharmacy.
The group brings together all the main pharmacy bodies representing community pharmacy to influence and inform the implementation of FMD in the UK. The group comprises expert representatives from NPA, AIM, CCA, PSNC, CPW, CPS and CPNI. It meets regularly with DH and MHRA to discuss how FMD will operate in UK pharmacies and to seek a practical and pragmatic solution for its implementation.
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