EFDA Directive Compliant Track And Trace System
The Ethiopian Food and Drug Authority (EFDA), operating under the Food and Medicine Administration Proclamation No. 1112/2019, has issued a pharmaceutical traceability directive requiring track and trace on all medicines circulating in the Ethiopian market. Under the EFDA Directive, every pharmaceutical product manufactured in or imported into Ethiopia must carry a unique GS1 DataMatrix code encoding GTIN, serial number, batch number, and expiry date, with product movement data submitted to the EFDA national traceability platform to combat counterfeit and substandard medicines, protect public health, and strengthen supply chain visibility. Sun Teknovation's Online Track & Trace system is fully equipped to meet the EFDA Directive requirements, enabling pharmaceutical manufacturers and importers to generate unique serialized codes, verify printed codes in real-time, manage multi-level aggregation, and report all product data directly to the EFDA platform. Our system ensures end-to-end compliance, helping you avoid import rejections, regulatory penalties, and market disruptions while maintaining seamless product flow into the Ethiopian market.
EFDA Directive Compliance Features
GS1 DataMatrix Code Printing (2 Side Print)
OCR / OCV Verification for EFDA Serialized Codes
PLC Controlled Machine Operation
EFDA Directive & Proclamation No. 1112/2019 Compliant
Complete Validation Documentation (IQ, OQ, PQ)
Line Level Serialization with EFDA Platform Integration
Air Based Rejection for Non-Compliant Packs
EFDA Directive Compliance Benefits
Inbuilt Server with EFDA Platform Connectivity
Compact Design for Easy Integration into Production & Export Lines
Auto-Adjustment for Multiple Carton Sizes
End-to-End Serialization with GTIN, Batch, Expiry & Serial Number
Anti-Counterfeit Protection & Public Health Safeguarding
Multi-Level Aggregation (Unit to Pallet)
Multiple Sensors for Precise Workflow
