Tag Archives: NCA

EMVO Calls For Enforcement Of FMD/DR

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. 

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