🇪🇬Egypt Planned

EPTTS (Egyptian Pharmaceutical Track & Trace System) Egyptian Drug Authority
Serialization Requirements
Level Required Identifier Type Description
Unit Required SGTIN Unit-level serialization with 2D DataMatrix (GTIN, serial, batch, expiry)
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 activation
Shipping Required At dispatch Shipment notification
Receiving Required Upon receipt Receipt confirmation
Authentication Required At verification points Product verification
Technical Requirements
EPCIS Version
v@Model.TechnicalRequirements.EpcisVersion
Data Format
XML
Integration Method
API and File Upload
Barcode Type
DataMatrix (GS1)
Required Fields
GTIN Serial Number Batch/Lot Expiry Date
Product Scope
  • Imported pharmaceutical products (Phase 1)
  • Locally manufactured medicines (Phase 2)
  • Over-the-counter medicines (Phase 3)
  • Controlled substances
Official Documents
View All
Guideline
EDA Track & Trace Guidelines
EDA View
Guideline
EPTTS Implementation Guide
EDA View
Key Deadlines
Regulatory Framework Publication
Nov 01, 2025
All manufacturers, warehouses, pharmacies must prepare for compliance
Phase 1 - Imported Medicines
Feb 01, 2026
Imported/international pharmaceutical products - mandatory compliance
Phase 2 - Local Production
Aug 01, 2026
Locally produced or packed pharmaceutical products - mandatory compliance
Phase 3 - OTC Extension
Dec 31, 2026
Aggregation requirements extended to include OTC drugs
Notes

Egypt's EPTTS is inspired by Turkey's successful ITS system. 91% of Egypt's pharmaceutical market is locally manufactured. System goal: end-to-end traceability and product authentication. Phased rollout expected over 3-5 years. Draft guidelines issued by EDA.

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Last updated: December 25, 2024