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.
Continue reading EMVO Calls For Enforcement Of FMD/DR
There is now little doubt that the Falsified Medicines Directive (FMD) will need to be delayed. The only question is, how will they do it? Let’s look at some facts and try to come up with a possible answer. Continue reading How Will They Delay The FMD?
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