Serialization of Drugs - A New Milestone for Smart Cities

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1Q 2017 | IN-4436


U.S. and EU Serialization of Pharmaceutical Drugs


The U.S.-issued Drug Supply Chain Security Act (DSCSA), to commence in 2017, mandates the serialization of pharmaceutical products to the smallest saleable unit. This is expected to be completed by 2023. Similarly, the European Union (EU)-issued Delegated Regulation (EU) 2016/161, known as the Falsified Medicines Directive, mandates the serialization of pharmaceutical products and deployment of anti-tampering devices commencing in February 2019. Belgium, Greece, and Italy are exempt from this and will have the option to defer application of the regulation by a maximum of six years.

The Road Toward Smart Manufacturing and Smart Logistics


Serialization involves assigning a unique identifier, or UI, (e.g. a number) to an item (e.g. pack, case, or pallet level). It utilizes radio frequency identification (RFID) or barcode technologies and stores the information from the UI (e.g. manufacturer, serial number, batch number, expiry date and national reimbursement, country of origin, et…

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