Authority: Egyptian Ministry of Health

Request Source: Regulation

Data Carrier: GS1 Data Matrix

Details:

A pilot application was started in 2019 to shape Egypt’s pharmaceutical traceability system in line with GS1 standards. Based on the pilot results, the Egyptian Drug Authority (EDA) released draft executive guidelines for the national track and trace system, open for public consultation until 29 September 2025.

Implementation will start on 1 February 2026 for imported finished products and 1 August 2026 for locally manufactured products. Products produced or imported before these dates are exempt.

The system is GS1-based — using EPCIS, GS1 DataMatrix, GTIN, SSCC, Batch/Lot, Expiry Date, and Serial Number — and applies to all pharmaceutical supply chain entities including manufacturers, importers, distributors, pharmacies, and hospitals.

All shipping events must be recorded in real time, with GLN and SSCC information, and aggregation verification before shipment.
Exemptions include special imports, clinical trial products, and free samples.

• GTIN
• Batch/ Lot
• Expiry Date
• Serial Number

Links:

https://eda.mohp.gov.eg/
https://mohp.gov.eg/News_webpart/dispNews.aspx?ID=947
https://eda.mohp.gov.eg/Files/1107_29_2016.pdf
https://eda.mohp.gov.eg/images/News/F_111.pdf
https://eda.mohp.gov.eg/Articles.aspx?id=26
https://eda.mohp.gov.eg/NewsALLEn.aspx