FMD DR now legislation


This month, the Falsified Medicine’s Directive Delegated Regulations, or FMD DR, became law in the majority of Europe. It introduces new safety features to ensure full traceability of any prescription item to make identification of fake medicines easier, and improves controls at EU external borders. Over £2m of fake drugs and medical devices were confiscated in the UK last year, part of a wider Interpol initiative involving 116 countries. In total there were 859 arrests and £10.9m of unlicensed and falsified medicines were intercepted, including dermal fillers, sedatives, anti-inflammatories and painkillers. Alistair Jeffrey, head of enforcement at the Medicines and Healthcare products Regulatory Agency, said: “Our intelligence-led enforcement operations have seized millions of counterfeit and unlicensed medicines and devices in the UK. This is just the tip of the iceberg, and we will continue to take action against known criminals, working with our international partners to stop illegal medicines from entering the UK.”

“FMD DR now legislation“

Under the new regulations all prescription medicine packs will be tamper-proof and feature a 2D barcode containing a unique serial number, product code, batch number and expiry date. A central database of all prescription only medicines has been established so operators can check a pack is genuine. Most pharmacies or healthcare institutions have computer systems that allow them to check the product is genuine and tell the database it has been used, or decommission it, as it is supplied. This gives a real-time view of legitimate product within the market. As dentists do not supply patient packs of pharmaceuticals to their patients, the supplier or wholesaler of these products will have responsibility for decommissioning the product before it is supplied to the practitioner.

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