The EDA mandates that every pharmaceutical product must have a unique identifier encoded as a GS1-compliant Data Matrix code. This code must contain the Global Trade Item Number (GTIN), batch number, expiration date, and a unique serial number. The serialization extends beyond individual units to secondary and tertiary packaging, creating a hierarchical traceability system that encompasses the entire supply chain from manufacturing to patient dispensing.

All serialization and aggregation data must be continuously reported in real-time to a centralized platform managed by the EDA. This system enables continuous monitoring of product status throughout the supply chain. Pharmacies, hospitals, and other distribution points are required to verify a product's authenticity through the EDA's real-time data system before dispensing, significantly reducing counterfeit risks and ensuring patient safety.

The EDA has established a unified electronic system for track and trace that requires mandatory registration and technical infrastructure integration from all supply chain participants. Factories, importers, distributors, warehouses, and pharmacies must link their systems to this centralized platform, including printing and electronic reading devices. This creates seamless connectivity across the entire pharmaceutical ecosystem.

Egypt's regulatory framework follows a strategic phased approach with clear deadlines. The implementation began with pilot projects in 2024 focusing on high-risk products such as vaccines and essential medicines. Serialization becomes mandatory for all prescription drugs in 2025, with imported human pharmaceutical preparations required to comply by February 1, 2026, and locally produced, packaged, or appointed pharmaceutical products by August 1, 2026.