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All you need to know about the Falsified Medicines Directive

December 5th, 2018

There are only two months left until the European Union Falsified Medicines Directive (FMD) is rolled out. Starting in February 2019 EU citizens will be protected from falsified or counterfeit medicines. However, this change is going to have an enormous impact on the entire pharmaceutical supply chain.

Under the FMD, all new packs of prescription medicines from February 2019 on are required to have two safety features. The first one is the Unique Identifier (UI), where a unique 2D barcode made up of four key elements. If the pack size permits, it also carries the same information printed in text adjacent to the barcode. The second one is the Anti-Tampering device (ATD), where the exact nature of the physical ATD will be decided by the manufacturer. If the ATD is broken, the medicine cannot be supplied.

European Medicines Verification System (EMVS)

In order to prevent falsified medicines from entering the legal supply chain, the European Medicines Verification System has been put in place. The European Medicines Verification System (EMVS) will guarantee medicines authenticity by an end-to-end verification. From the manufacturer, who will apply the unique identifier code to pack labelling, to the pre-wholesaler who will store the manufacturer’s medicines, to the wholesaler who will scan and verify them, to the community pharmacy that will check that the anti-tampering device (ATD) is intact, to lastly the hospital pharmacy that will follow the same process as the community pharmacy.  When a medicine is scanned, the Medicines Verification System will send back the status of the product as either “active” (can be distributed or dispensed), or “inactive” (cannot be distributed or dispensed). This may happen if the pack has been withdrawn, stolen, or already dispensed. The NMVS alerts authorities if a potential falsified medicine is identified.

 Honeywell’s answer to FDM

 Honeywell has a series of 2D barcode scanners that can be the solution and answer the FDM and prepare you for this change. Either you are looking for a handheld or a hands-free scanner, Honeywell has a range of products suitable for hospitals and pharmacies. When it comes to handheld scanners Voyager 1400g, full in white, and Xenon 1900h, the best-selling Xenon 2D scanner in a disinfectant-ready housing, are the perfect answers to FDM. However, if you are looking for hands-free scanners, take a look at Orbit 7190g, the legendary Orbit revamped as the first hybrid scanner with both 1D & 2D scan engines, or at Genesis 7580g, the world’s first presentation area-imaging scanner. Contact BlueStar today for more information and get your own scanner before FMD is effective in February.




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