The Falsified Medicines Directive is a directive that will be fully incorporated into UK law in 14 months, has been created in order to protect public health and safety from falsified medicines. These falsifications have become more and more sophisticated the risk that they pose to patients in the EU are increasing each year.
This legislation aims to provide a secure supply chain for manufacturers through wholesale and pre-wholesale to dispensers and to patients in order to improve safety. The Pharmaceutical Journal has been looking into the Directive and has conducted a survey which has shown the majority of pharmacists support the Falsified Medicines Directive, or FMD, in theory but are concerned about how this change on the law could operate in practice.
FMD is European wide legislation which will aim to offer a safe chain from manufacturers through the wholesale channels and pre-wholesale to dispensers and then on to patients. The legislation will go live on the 9th February 2019. The Directive will be put into action across the UK with the assistance of The Medicines and Healthcare products Regulatory Agency, or MHRA, who is working out the best way to implement the new law through the FMD Implementation Advisory Board.
Once incorporated into UK law, medicine packs will have to be issued with a tamper proof security seal as well as a unique identifier which will be imbedded in a 2D barcode and will allow the medicine to be tracked from manufacturer down the supply chain to the patient. This identification data will be stored on an EU-wide central hub called European Medicines Verification System. However, the Pharmaceutical Journal’s survey, carried out on 656 Royal Pharmaceutical Society members, showed that 27% were unaware of the date the FMD is officially incorporated into UK law, and of the 73% that were aware, 72% said that they did not understand the knock on effects of the FMD on their work.