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?
…a comprehensive exploration of the intersection between healthcare supply chains, track and trace technology, standards and global regulatory compliance
DISCLAIMER: RxTrace contains some of the personal thoughts, ideas and opinions of Dirk Rodgers. The material contained in RxTrace is not legal advice. Dirk Rodgers is not a lawyer.
The reader must make their own decisions about the accuracy of the opinions expressed in RxTrace. Readers are encouraged to consult their own legal counsel
and trading partners before taking any actions based on information found in RxTrace. RxTrace is not a vehicle for communicating
the positions of any company, organization or individual other than Dirk Rodgers.
RxTrace, a comprehensive exploration of the intersection between healthcare supply chains, track and trace technology, standards and global regulatory compliance.
Contact Us | Privacy Statement
Copyright © 2009-2020 Dirk Rodgers Consulting, LLC. All Rights Reserved.
RxTrace is a registered trademark of Dirk Rodgers Consulting, LLC