Only if current ones can’t read 2D Data Matrix codes.

The system includes "Error Declaration" events for almost every action (e.g., Commission Error, Shipping Void, Receiving Error Declaration). These allow users to cancel a previously reported transaction and correct the data record.

Yes. All entities (factories, distributors, pharmacies, and hospitals) must acquire 2D Scanners capable of reading Data Matrix codes and decoding them for the system.

 Not necessarily, but their existing systems (like ERP, MES, or WMS) must be capable of integrating with the National System using the EPCIS protocol. They must be able to generate and send data files in XML/EPCIS format.

The system tracks "exits" through several specific event types:

• Dispensing: When a pharmacy or hospital gives the medicine to a patient.
• Destruction: Used to report packs that are damaged or expired and must be disposed of.
• Sampling: When packs are pulled from a batch for quality testing or research.
• Stolen/Missing: To report units that are lost or involve criminal activity.

 This event is recorded when a larger shipping unit (like a pallet or big crate) is opened to separate the individual boxes for independent distribution or sale.

Manufacturers are responsible for the "birth" of the data through several key steps:

• Commissioning: Reporting the creation of the unique Product Code and Serial Number.
• Packing (Aggregation): Linking individual packs into larger units (cartons/pallets) using an SSCC code.
• Shipping: Recording the movement of these units to the next point in the chain.

The entity must record a "Return" event on the system. If the return involves products previously marked for export, it must specifically be labeled as "from Export" to maintain a clear history of the pack's location.

The pharmacist must scan the 2D Data Matrix on the outer box for every partial sale until the last unit is gone. Consequently, the pharmacy must keep the original outer packaging until the very last dose is dispensed to ensure the code remains available for scanning.

Distributors and warehouses must scan and register the receipt of a shipment within a maximum of 48 hours from the actual physical delivery. Failure to do so triggers a regulatory alert.

Pharmacies must stop the sale of any unit with an unverified or invalid code and report it immediately to the EDA.

 If an entity fails to comply with the tracking requirements, the EDA may :

• Issue a formal written warning.
• Temporarily suspend the circulation of the violating product.
• Temporarily stop supplying products to the violating entity.
• Impose financial penalties.

Yes, the following are currently excluded :

• Unregistered imported products requested for specific individuals/entities.
• Products for clinical trials.
• Free medical samples intended for research or medical promotion.

Aggregation is the process of linking individual packs (child) to a larger shipping unit (parent), such as a carton or pallet. This larger unit is assigned a Serial Shipping Container Code (SSCC), allowing the entire shipment to be tracked through the supply chain without scanning every individual box at every stop.

The system is mandatory for all entities in the Egyptian pharmaceutical market, including :

• Local manufacturers and importers.
• Distributors and licensed warehouses.
• Public and private pharmacies.
• Governmental, university, and private hospitals.
• Logistics service providers (3PL).

Yes, via the T&T portal, but ERP integration automates reporting.

The reporting model will be vertical, with all traceability events reported directly to the national hub. At this stage, no requirements have been defined for partner-to-partner data sharing.

The EDA Unified National Track & Trace Platform will follow a centralized model, requiring all traceability events to be reported directly to the national hub

 Integration is via GS1 EPCIS standards. Data can be transmitted using secure APIs or file exchanges in XML/JSON/CSV formats. Detailed technical specifications and API documentation are provided during company onboarding. A dedicated company Technical Helpdesk is available to support manufacturers and importers during integration.

Yes. During the transition stage, factories that do not have DataMatrix printing capability on their packaging lines may apply to use alternate carriers such as RFID or NFC.

These carriers will temporarily represent the same GS1 DataMatrix data (GTIN, UID, Batch, Expiry) until the factory is ready to upgrade its printing technology.

Conditions:

• The alternate carrier must hold the same information as the GS1 DataMatrix.

• The company must provide the necessary middleware or mapping to ensure the data is fully compatible with the national Track & Trace system.

• This option is temporary. After the transition period, only GS1 DataMatrix printed on-pack will be accepted.

Please review the standard published by GS1 (link below) concerning use of RFID as an example of what EDA MIGHT approve. https://www.gs1.org/standards/rfid

The 3PL records aggregation, shipping, and receiving using its GLN.

Yes. 3PLs within Egypt must register GLNs and are responsible for reporting aggregation, shipping, and receiving events from their facilities. Regional Hubs outside Egypt need not register with GLN. Brand owners remain accountable to EDA for ensuring 3PL compliance.

Local Products: For local manufacturers, commissioning and aggregation must be recorded as events directly in the national system at the time of packaging.

Imported Products: EPCIS data must be uploaded before the products enter Egypt.

o If shipments are consolidated at regional hubs, EPCIS reporting can take place at the point of dispatch from the hub, provided it is before Egyptian customs clearance.

o Commissioning and aggregation events performed outside Egypt are not registered as events in the national system. Instead, importers must upload the related data files as reference.

o Once the shipment physically enters Egypt and receives customs release and EDA approval, these transactions must then be recorded as official trackable events in the national system.

Example:

A company imports 100,000 packs from a foreign manufacturer. EPCIS data is uploaded prior to clearance at Alexandria Port or Cairo Airport. Once cleared by customs and approved by EDA, the commissioning and aggregation events for those packs are entered into the system as official events.

The manufacturer or importer initiates a “Recall Event.” All affected serials are blocked. Pharmacies scanning them will receive “Invalid – Recalled.”

Expired products are reported as a “Decommission Event.”

Example: Batch B123 expired Dec 2026 → all serials from B123 marked “Decommissioned – Expired.”

The system rejects it, dispensing is blocked, and EDA is notified.

Pharmacists or hospital staff scan the serials before giving it to the patient. The system verifies validity and records a “Dispense Event.”

Example: serial SN000000123456 → status updated to “Dispensed.”

The receiving site scans the SSCC or serials. The system logs the “Receiving Event.”

Example: Distributor scans SSCC 00312345678901234567. System updates all child serials to status “Received.” If not scanned within 48 hours, a compliance alert is triggered.

The shipping site (factory, importer, or 3PL) records the EPCIS “Shipping Event.”

Example: Factory GLN 10001 → ships SSCC 00312345678901234567 → Distributor GLN 20001

Each carton/pallet is assigned an SSCC (Serial Shipping Container Code, AI 00).

All child Serials inside are digitally linked to the SSCC.

Example:

• SSCC: 00312345678901234567

• Contains Serials: SN000000123456 → SN000000123475

System mapping: SSCC 0031234567890123

The EDA (Egyptian Drug Authority) is Egypt's regulatory body responsible for:

• Drug registration and approval
• Pharmaceutical quality control
• Track and trace system (EPTTS)
• Import/export control