WHAT IS SERIALIZATION?

“Serialization” is the process of assigning a unique identifier, often in the form of a serial number or a specific code, to individual drug packages. This unique identifier facilitates the tracking and tracing of pharmaceutical products throughout the supply chain.

A “sellable unit” refers to the smallest packaged form of a pharmaceutical product designed for sale or dispensation to end users, typically patients. Each sellable unit is marked with a unique serialized identifier, which ensures its traceability as it moves through various stages of the supply chain.

Serialization is a critical component of regulatory compliance for traceability, enabling stakeholders—including manufacturers, distributors, and pharmacies—to authenticate and monitor the movement of each drug product. By distinctly identifying each sellable unit, regulations such as the Drug Supply Chain Security Act (DSCSA), the European Falsified Medicines Directive (EU-FMD), and China's Drug Administration Law seek to safeguard patients by preventing counterfeit or tampered products from entering the marketplace. Through these measures, serialization significantly enhances the integrity and safety of pharmaceutical distribution, ultimately fostering public trust in healthcare systems.