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
Beginning in less than two weeks, all packages of prescription drugs entering the EU pharma supply chain must contain a 2D barcode encoding the EU serialized ‘Unique Identifier’ (see “The ‘Unique Identifier’ in the EU Delegated Act”). More importantly, all drugs that have an FMD unique identifier on them at the point of dispense after February 9, 2019 must be “verified” and decommissioned through the National Medicines Verification System (NMVS) (see “What’s So Hard About Unique Identifier Verification?” and “Decommissioning Under the FMD/EUDR”). It looks like my prediction of FMD delays was wrong (see “How Will They Delay The FMD?”) but at least Denmark has just moved to solve a serious FMD dilemma with a kind of delay. Let me explain.Continue reading FMD: Denmark Moves To Solve FMD Dilemma
Congratulations, you’ve just connected to the EU Hub and you are authorized to begin uploading production data ahead of the February 9, 2019 deadline. It’s been a long road. Most pharma marketing authorisation holders (MAH) report taking six months from initial onboarding application to authorization. Now what? Continue reading FMD: Your Initial Upload To The EU Hub
Two weeks ago, an EU Member State Expert Group connected to the European Commission (EC) published a paper aimed at explaining what hospitals should do to meet their obligation to verify and decommission drugs after the Falsified Medicines Directive (FMD) Delegated Regulation (EUDR) goes into effect on February 9, 2019. The new paper is all about aggregation and its use by Continue reading Aggregation Under the FMD
The EU Delegated Regulation (EUDR) of the Falsified Medicines Directive (FMD) mandates that all serial numbers placed on non-exempt drugs entering the EU supply chain after February 9, 2019 must be ‘sufficiently randomised’. What is sufficient randomisation? The regulation says one thing, and the European Medicines Verification Organization (EMVO), the operator of the EU Hub, says something beyond that. What should drug manufacturers do? The EMVO recently updated their messaging. Let’s take another look at this important topic. Continue reading EMVO Admits, ‘Insufficient Randomisation’ Warnings Can Be Ignored
Just after I posted my last FMD essay on RxTrace (see “FMD, One Year Out”) I found out that the European Commission had published version 9 of their “Safety Features for Medicinal Products for Human Use, Questions and Answers”. This is must reading for anyone with questions about how to interpret the most confusing provisions of the Falsified Medicines Directive (FMD) (also known as EU Directive 2011/62 and which amends Directive 2001/83) and the Delegated Regulation (EUDR) (also known as EU Regulation No 2016/161) (see “The E.C. Officially Published The Pharma Safety Feature Delegated Act This Morning“).
With each major revision this Q&A document grows. This time it grew substantially with the addition of 21 new questions and answers and updates to four previously posted answers.
But there is one provision of the FMD that defies explanation, even though the Q&A document burns two Q&As to attempt it. That provision in the FMD is Section 1 of Article 45a, which basically says, in part, that you cannot put an anti-tamper device on non-prescription drugs unless the EC or a Member State specifically says you can. What’s going on here? Continue reading The Most Head-Scratching Section Of The FMD
Last Friday marked one year to go for the start of the Falsified Medicines Directive (FMD) and the Delegated Regulation (EUDR) in the European Union (EU) (see “More Concerns With The FMD/EUDR Big Bang Start”). With the one year delay in the serialization and verification requirement of the Drug Supply Chain Security Act (DSCSA) in the US, the deadlines for these two markets are only about 10 weeks apart, assuming there won’t be any more delays. I don’t expect another delay in the manufacturer’s serialization and verification deadline in the US, and I haven’t talked with anyone who expects Continue reading FMD, One Year Out