The Saudi Food and Drug Authority (SFDA) has implemented drug track-and-trace requirements for pharmaceutical products sold in Saudi Arabia. The system requires serialisation at the saleable unit level and integration with the SFDA's national traceability platform.
Serialisation Requirements
All pharmaceutical products sold in Saudi Arabia must carry a unique identifier encoded in a 2D DataMatrix barcode. The identifier must contain: a GTIN (Global Trade Item Number); a serial number; a lot number; and an expiry date. The barcode must comply with GS1 standards and meet SFDA-specified print quality requirements.
SABER System
The SFDA's SABER (Saudi Arabia Conformity Enablement Program) system is the national platform for product registration and conformity assessment. Pharmaceutical companies must register their products in SABER and submit traceability data for each shipment entering Saudi Arabia. Non-compliant products may be held at Saudi customs.
Compliance Timeline
Saudi SFDA has implemented serialisation requirements in phases: vaccines and biologics (2018); high-risk medicines (2019); all prescription medicines (2020); OTC medicines (2021). Companies exporting to Saudi Arabia must ensure their serialisation systems are compatible with SFDA requirements and that traceability data is submitted correctly to SABER.