Get ready for Egypt’s EDA Track & Trace (2026 deadlines)
When Track & Trace goes live, the biggest risk is disruption. If UID handling, code quality, warehouse scans, and reporting don’t work together, shipments stall, teams chase exceptions, and compliance exposure grows.
Remove the handoffs. Use one partner accountable for the full Egypt EDA workflow.
What is Egypt’s EDA?
Egypt’s Track & Trace regulation introduces a national system that allows the Egyptian Drug Authority (EDA) to track regulated pharmaceutical products across key supply-chain steps. In practice, it means each saleable pack is identified with a government-issued Unique Identifier (UID) encoded in a GS1 DataMatrix, and specific supply-chain events (like commissioning, shipping, receiving, and dispensing) are reported to the national platform. This is more than a packaging requirement: it changes how products are identified and how movements are recorded digitally.
Who needs to comply in Egypt?
Compliance typically impacts any party that manufactures, imports, handles, distributes, stores, or dispenses regulated products in Egypt. That includes local manufacturers, importers, warehouses/3PLs, distributors/wholesalers, and dispensing points (pharmacies/hospitals) depending on the scope enforced for their operations. Even if you don’t print codes yourself (for example, a 3PL), you may still have responsibilities to scan, record, and report events.
What changes for importers?
Importers usually need a defined workflow to ensure products entering Egypt meet UID and reporting requirements. That includes obtaining or aligning UIDs per product/batch, ensuring the correct code is applied (or managed under transitional rules), and ensuring required data and events are available before and after entry into the country. The biggest operational risk for importers is “last-minute relabeling” or unclear responsibilities between the foreign manufacturer, importer, and local logistics partners—so contracts and SOPs need to be explicit.
What changes for warehouses and 3PLs?
Warehouses and 3PLs often become the operational backbone of compliance because they execute receiving, storage, picking, and shipping. Under track & trace, “just moving boxes” is not enough; you typically need scanning workflows tied to traceability events (receive and ship at minimum). If aggregation is used, the 3PL must also preserve parent-child relationships (for example, if cases are broken and re-packed, the aggregation relationships need to be updated). The practical goal is to avoid shipments that cannot be confirmed as received or reconciled digitally.
What happens at pharmacies or hospitals?
Dispensing points usually verify and/or record the final supply event, linking the pack’s UID to a dispense action and updating the pack’s status in the national system. Where and how this is implemented can vary by rollout approach, but the business impact is consistent: dispensing workflows must be simple and fast (scan → confirm), and exception handling must be clear (damaged code, returned pack, partial dispensing scenarios, etc.).
OPTEL DELIVERS THE MOST RELIABLE PARTNERSHIP IN PHARMA TRACEABILITY
With over 35 years of experience, OPTEL delivers proven, scalable solutions in serialization, vision inspection, and regulatory compliance. As your single, accountable partner, we help you stay always audit-ready, minimize downtime, and grow with confidence.
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