Under the Falsified Medicines Directive (FMD), starting on February 9, 2019 drug manufacturers must begin affixing a new Unique Identifier and an anti-tamper device to all consumer packages of prescription drugs (see “The E.C. Officially Published The Pharma Safety Feature Delegated Act This Morning”). The Unique Identifier must be composed of a Product Code, Serial Number, Batch Number, Expiration Date and, where required, a National Reimbursement Code (see “The ‘Unique Identifier’ in the EU Delegated Act”). This data must be uploaded to the E.U. Hub prior to shipment into the supply chain. All of the details are spelled out in the Delegated Regulation (EUDR).
One of the more interesting aspects of the FMD/EUDR is the Product Code. Continue reading The FMD Product Code
One of the best sessions during last week’s LogiPharma conference held in Princeton, NJ was called “Staging Your Implementation To Meet The 2017 Deadline”. The “deadline” refers to the November 27, 2017 deadline for drug manufacturers to apply unique serial numbers to all drug packages and cases shipped into the U.S. market as required in the Drug Supply Chain Security Act (DSCSA), but it can also refer to similar deadlines with similar requirements in a number of other regions of the world. The panel included knowledgeable representatives from two of the largest global pharma manufacturers selling into the U.S. market. Both manufacturers are facing serialization mandates in the E.U., Brazil, Turkey, South Korea, China, India, Argentina and a few countries in Africa as well as the U.S.
As they spoke about their respective programs for meeting the requirements, one of the speakers mentioned that roughly 90% Continue reading Pharma Serialization: Going Totally Global Soon
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