EU FMD: Aggregation Is Not Mandated, But It Will Be Necessary

Ever since the E.U. Falsified Medicines Directive (FMD) was passed in 2011 my European friends have touted the fact that their government mandated solution would take a “bookend” approach.  The implication was always that it would be much less complex than the ePedigree approaches that were being planned by various U.S. states, and then by

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3 thoughts on “EU FMD: Aggregation Is Not Mandated, But It Will Be Necessary”

  1. The conclusion is obvious from reading the FMD. There is not a simple things like POD as the entire security of the system relies of the ability to decommissioned the serial numbers. If we want to avoid aggregation, then we need to study additional measure that are definitely not included in the regulation where the serialization information is combined with anti counterfeiting solutions.

  2. Hi, Dirk! Thanks for putting together all my concerns regarding the EU FMD. I cannot stop hoping that EMVO will finally realize this deficiency and do further improvements on the EU-Hub to create the ability of receiving aggregation data.

  3. Well said. Thanks for analysis. Just one minor correction: Norway and Switzerland are part of EU FMD covered area, Norway due to EEA and Switzerland due to opt-in (which was requested by the local industry).

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