![]() Pharmacists (or other authorized persons) will scan the codes during the dispensing process and these codes will be checked against those local databases. ![]() This will push data down to appropriate national data repositories run by corresponding National Medicines Verification Organisations (NMVOs). Manufacturers (and licensed parallel traders) will code their products and report data to a central EU Hub run by the European Medicines Verification Organisation (EMVO). The data must also be printed in human readable form, ideally adjacent to the code. Some countries require a fifth data string for national use. The code must contain a minimum of four pieces of information: batch number, expiry date, global trade item number (GTIN) and a randomized serial number. The FMD requires that all unit-of-sale packs of prescription medicines (with potential exceptions for perceived low-risk products) must carry a “safety feature” comprising a Data Matrix code and human readable data, and must be tamper-evident. Far-reaching, mandatory requirements for product coding, traceability and tamper-evidence will be enforced in over thirty countries. The EU Falsified Medicines Directive and What It MeansĮurope’s Falsified Medicines Directive ( FMD) comes into full force in little over a year, on 9 th February 2019.
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