FMDFalsified Medicines Directive

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Integration of Falsified Medicines Directive (FMD) with the pharmacy

The Falsified Medicines Directive by the European Union Parliament aims to increase the security of the manufacturing and delivery of medicines across Europe and protect patients by preventing falsified medicines from entering the supply chain. This objective is achieved for Church Pharmacy with the mobile app developed by Space Stem in which all products from different suppliers are scanned with zebra devices, cross-verified with NMVS – National Medical Verification System online and approved or rejected with a reason code, before dispatch.

The new regulation requires manufacturers to place safety features such as a unique identifier (UI) in the form of a 2D data matrix (barcode) and an anti-tamper device (ATD) that allows the assessment of the authenticity of a medicine at the time of supply to the distributor (Pharmacy). Manufacturers and distributors are connected to NMVS portal through APIs. The manufacturer can update NMVS once the goods have been sent to the distributor and the distributor can first verify the medicines when they arrive and update NMVS once they dispatch the medicines. Falsified medicines include those medicines with little or no active ingredients, the wrong active ingredients, fake or tampered packaging, and those where products and/or packaging have been stolen for re-use or re-sale.

FMDlite system of Space Stem acts like a regulatory tool that finds and reports falsified medicines in the supply chain, thereby preventing unlicensed internet sites from trading falsified medicines to the public. Such products pose an unacceptable risk to patients, as well as damage business of genuine manufacturers, wholesalers and pharmacies.

Under the Directive, all new packs of prescription medicines placed on the market in Europe from February 2019 onwards will need to have safety features like product authentication, which means visually checking the ATD and perform a verification and decommissioning scan, "at the time of supplying it to the public".

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