Ethiopia's EFDA Finalizes Pharma Traceability Deadlines, Mandates EPCIS Reporting by June 2026

The pharmaceutical industry is urged to finalize compliance preparations following the Ethiopian Food and Drug Authority (EFDA) announcement of firm deadlines for its new national track and trace system, the EFDA-MVC (Medicine Verification and Control) Traceability Hub. This initiative, formalized under the Pharmaceutical Products Traceability Directive, is set to revolutionize pharmaceutical supply chain integrity in Ethiopia by implementing mandatory serialization, aggregation, and comprehensive event reporting.

🛑 Critical Compliance Milestones for Exporters and Country Sale
The regulatory notice confirms a phased rollout for all companies exporting medicinal products for sale or distribution into the Federal Democratic Republic of Ethiopia:

The Ethiopian Food and Drug Authority (EFDA) has established a firm timeline for all pharmaceutical exporters utilizing the EFDA-MVC Traceability Hub. The mandatory onboarding process began with the July 25, 2025, portal signup deadline. The most critical upcoming milestone is June 3, 2026, when all pharmaceutical manufacturers must officially start reporting all serialization and supply chain events, such as product commissioning and shipping, using the required EPCIS standards. Following this, companies must be fully ready for and begin reporting Aggregation events (linking cartons to cases and cases to pallets) by the final mandatory deadline of December 1, 2026, when the grace period for aggregation officially ends.

Technical Requirements: Serialization and Data Standard
To ensure seamless data exchange and product verification, the EFDA is enforcing adherence to global GS1 standards:
1. Unique Identification: All saleable units must be marked with a GS1-compliant 2D DataMatrix barcode.
2. Data Elements: This code must clearly encode the four required data elements:
o Global Trade Item Number (GTIN)
o Unique Serial Number
o Batch/Lot Number
o Expiry Date (in YYMMDD format)
3. Reporting Protocol: All transactional data must be submitted to the EFDA-MVC Hub via the Electronic Product Code Information Services (EPCIS) protocol.
Industry Implications and Next Steps
The swift nature of these deadlines requires immediate strategic action from all exporting pharmaceutical manufacturers and Marketing Authorization Holders (MAHs). Companies must ensure their Level 3 (site-level) and Level 4 (enterprise-level) serialization systems are fully integrated with the national EFDA-MVC portal and capable of generating EPCIS messages for all required events. Delaying implementation, particularly for complex processes like aggregation, puts companies at severe risk of supply chain disruption and non-compliance penalties after the specified deadlines.

A Partner in Compliance: Kevision Systems
Navigating the complexities of the Ethiopian EFDA mandate requires proven expertise and robust technology. Kevision Systems provides end-to-end Track & Trace solutions, ensuring seamless integration with the EFDA-MVC Traceability Hub. Our proprietary KevSecure® Serialization Suite is designed to simplify compliance, supporting GS1-standard serialization, aggregation (AggreSecure®), and automated EPCIS event reporting required by the June 2026 deadline and beyond. Partner with Kevision to secure your market access and ensure the integrity of your pharmaceutical supply chain in Ethiopia.

Contact Kevision Systems today to discuss your compliance roadmap.

Kevision Systems ST-101, One42, Ashok Vatika, Near Jayantilal Park BRTS, Bopal Rd, Ambli, Ahmedabad, Gujarat 380058

Since its inception, Kevision has been on a mission to develop software and systems to protect the authenticity of medicines and other products. In its first year, Kevision launched three modern technologies to provide Serialization and Camera-based inspection systems.

This release was published on openPR.