Pharmaceutical serialisation is the process of assigning a unique identifier to each saleable unit of a medicine. Serialisation is the foundation of all drug track-and-trace systems and is required by DSCSA, EU FMD, China NMPA, and most other national drug traceability regulations.
GS1 SGTIN Standard
The GS1 Serialised Global Trade Item Number (SGTIN) is the global standard for pharmaceutical product identification. An SGTIN consists of: a GS1 Company Prefix (assigned by GS1 to the brand owner); an Item Reference (identifying the specific product); and a Serial Number (unique to each individual pack). The SGTIN is encoded in a GS1 DataMatrix barcode along with lot number and expiry date.
Serialisation System Architecture
A pharmaceutical serialisation system typically consists of: a Serialisation Management System (SMS) that generates and manages serial numbers; line-level integration with packaging lines for barcode printing and verification; an aggregation system for case and pallet-level serialisation; and an L4 enterprise system for serial number management and reporting.
Multi-Country Compliance
Pharmaceutical companies selling in multiple markets must comply with different serialisation requirements simultaneously. Key differences include: barcode format (DataMatrix vs QR code); data elements required; aggregation requirements; and reporting obligations. A centralised serialisation platform that can configure market-specific requirements is essential for multi-country compliance.