Beyond Item Level Serialization: Extending Traceability Schemes To Secondary And Tertiary Packaging

By Mark Shaffer

Falsified and counterfeit medicines are a chronic problem for the pharmaceutical sector, with a third of all shipments in the worst affected parts of the world estimated to contain fake medicines. Highly portable and often extremely valuable, medicines continue to be a favorite with those determined to fake products or subvert the system for illegitimate gain. Faced with this continued global threat, legislatures around the world are responding by tightening the supply chain to stamp out illicit goods.

Over the next few years, major markets and trading blocs including the EU, the USA and Latin America will enact legislation mandating that each patient pack will have its own unique identification number. Add to this schemes that are already either in force or being implemented in China, India, South Korea and Turkey and it is clear that there is significant momentum towards establishing item level serialization as the global standard for proving the origin and source of each and every pharmaceutical pack. Against this backdrop, counterfeiters across the world will find it much harder to infiltrate legitimate markets. Even if the packaging and branding look authentic, item-level serialization will help prove an item’s authenticity.