Serialization of Drugs - A New Milestone for Smart Cities

by Raquel Artes | 1Q 2017 | IN-4436

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.

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