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Sharp Serialisation Update

We are experts in serialisation, which is the application of a specific, individual serial number to a unit of sale.

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By: Tim Wright

Editor-in-Chief, Contract Pharma



More than 30 countries worldwide currently have or are considering regulatory requirements for the unit-of-sale serialisation of prescription pharmaceutical products. Their main goal is to make sure that the pharmaceutical supply chain is safe and free from counterfeit or adulterated drug products. In the US, the Drug Quality and Security Act (DQSA) was recently passed into legislature. Implementation of its regulations will be staggered, but it will require all prescription drugs to be uniquely identifiable by November 2017, and traceable through the supply chain by November 2023. In the European Union, the Falsified Medicines Directive includes similar requirements. At Sharp, we have been providing our customers with an innovative serialisation service since 2007, consistently meeting or exceeding the current regulatory requirements as they evolve. Our US and European packaging facilities have industry-leading processes and equipment capable of flexible, scalable serialisation of all of our clients’ products.

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