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ezFMD: Software to support compliance with the Falsified Medicines Directive

The FMD (Falsified Medicines Directive 2011/62/EU) requires each manufacturer to add elements to a pack of prescription medicine to make it harder to falsify. Examples of falsification would include counterfeiting a medicine, changing the expiry date or even supplying a medicine through an unapproved  route. The objective is to ensure that as best as one can each and every patient receives the medicine in good condition as their doctor prescribed and no less. Overall management of verification is organised at a European level (by the EMVO). FMD systems are located in each EU country – examples include the IMVO, E-Vis and the DMVO.

Elements to protect patients One of these elements is each pack of medicine will receive a unique serial number at the manufacturing site. This unique serial number will allow the medicine to later be verified or marked as used (dispensed). Once marked as used, that individual pack cannot be supplied again. Every pack sold in a pharmacy will have to be scanned at the time of supply to a patient. Medicines supplied through other means, such as hospital or clinic use will also have FMD related means of validation.

ezFMD allows the medicines wholesaler or pharmacist to validate any pack or mark it as supplied in an easy manner, ensuring compliance with the law. All that is required is a basic PC and a scanner, along with ezFMD software installed. Initial registration with the NMVO in the country is very straightforward.  Remember, the deadline for implementation is 9th February 2019, don’t leave it too late!

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