🇪🇬Egypt In Progress

Track & Trace Egyptian Drug Authority (EDA)
Serialization Requirements
Level Required Identifier Type Description
Unit Required SGTIN Unit-level serialization with 2D DataMatrix
Case/Bundle Required SSCC Aggregation at case level required
Pallet/Shipper Required SSCC Pallet level aggregation required
Reporting Obligations
Event Type Required Timing Description
Commissioning Required Before distribution Serial number generation reporting
Shipping Required At dispatch Dispatch goods to next GLN
Receiving Required Upon receipt Verify and accept serialized/Aggregated goods from supplier
Aggregation Required Before distribution Repack units into new cartons/pallets
Disaggregation Required On Hierarchy Changing Open carton/pallet and separate child units
Decommissioning Required Inactivate Unit Product Mark damaged, expired, or dispensed packs inactive
Technical Specifications
  • EpcisVersion: 1.2,2.0
  • DataFormat: XML,Json
  • IntegrationMethod: API
  • BarcodeType: DataMatrix (GS1)
  • RequiredFields: GTIN, Serial Number, Batch/Lot, Expiry Date


Some updates in law 804

  • Replacing GLN with the Location Code
  • Replacing GTIN with the Trade item number
  • Using the term Serial Number instead of UID (Unique Identifier)
  • Cancellation of obtaining the Unique Identifier (UID) directly from the National Electronic System.




Product Scope
  • Imported pharmaceutical products
  • Locally manufactured medicines
Exempt Products
  • Free Medical Sample
  • Clinical Trial Products
  • Non Registered Products For Individuals
Official Documents
View All
Regulation
Law Number 804/2025
EDA
Regulation
Law Number 475/2025
EDA
Guideline
Draft Guidelines For Unified National Platform For Traceability
EDA
FAQ
Q&A
EDA
Key Deadlines
Regulatory Framework Publication
Nov 01, 2025
All manufacturers, warehouses, pharmacies must prepare for compliance
Phase 1 - Imported Medicines
Feb 01, 2026
Imported pharmaceutical products - mandatory compliance
Phase 2 - Local Production
Aug 01, 2026
Locally produced pharmaceutical products - mandatory compliance
Notes

Receiving Event : In wholesalers (Maximum 48Hrs After Physical receiving)

Common Questions
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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.

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

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

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.

Last updated: February 14, 2026