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Serialisation: Are you Ready?

In February 2019, the EU puts serialised authentication into effect. It is specified in the 2013 Drug Supply Chain Security Act. This could include verification through the packaging lines or throughout the supply chain with the intent of stemming the counterfeiting epidemic across the EU. The new regulation, EU 2016/161, is a supplement to Directive 2001/83/ EC, otherwise known as the Falsified Medicines Directive.

The goal is for digital accountability from the manufacturer to the pharmacist. This can include the packaging and the pills themselves, with emphasis on ways to prevent tampering with them.

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Randice Altschul
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