Wait. I thought the Falsified Medicines Directive and its companion Delegated Regulation (FMD/DR)—which has been in effect since February 9, 2019—was a mandate that would be enforced. Turns out, it was apparently just a suggestion. No actual government enforcement. In fact, according to new estimates by the European Medicines Verification Organization (EMVO) and the National Medicines Verification Organizations (NMVOs), only 60% of drug manufacturers and 75% of “other” supply chain actors (pharmacies, hospitals, wholesalers, dispensing doctors etc.) have connected to the medicines verification systems (the “system of repositories” mandated in the FMD/DR). A partial result is that one out of every 33 verification attempts at pharmacies and hospitals who are connected result in a ‘false alert’. That is, an alert that the drug being verified is not in the repository or the scan is not being interpreted correctly.
…a comprehensive exploration of the intersection between healthcare supply chains, track and trace technology, standards and global regulatory compliance
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