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THE PHARMA REVIEW (SEPTEMBER - OCTOBER 2016)

Getting Market Ready for 2017 Pharmaceutical Serialization

Richard Nemesi

Introduction: January 1, 2015 initiated a stepwise supply chain mobilization towards a new era of pharmaceutical product serialization in the US. The US is not the first country to institute measures to control suspect and illegitimate drugs. Several countries around the world (including Argentina, Brazil, Canada, China, India, South Korea and Turkey) have already begun instituting nationwide track and trace regulations in efforts to protect public health by reducing the fast rise in counterfeit drugs entering the supply chain. While each nation or region follows their own specific guidelines and/or legislation, nearly all are built around GS1 standards. For packaging manufacturers producing products for the US pharmaceutical marketplace, it is vital to understand the key points of the pharmaceutical serialization regulation. 

 

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