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Argentina Implements Second Phase of Traceability System for Drugs

Argentinean authorities recently issued a regulation (Disposition 963/2015) that implements the second phase of the traceability system for drugs by adopting new technical requirements and parameters. Slated to enter into force on 1 March, the updated system covers products in all dosage forms containing one of 72 active pharmaceutical ingredients either as a single drug or in combination with any other APIs, including registered products and products that may be registered in the future.

Drug registration holders must include in the packaging of covered drug applications a device capable of storing a unique identifier in accordance with the recommendations of standard GS1. That device must include the commercial code of the product (Global Trade Item Number), a serial number of up to 20 alphanumeric characters, the lot number, and the expiration date. Regardless of the storage device used, all required information must be provided in human-readable format.

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