Introduction

Further to our recently shared publication on the Egyptian Drug Authority’s (the “EDA”) Decree No. 161 of 2025 regarding the unified coding of pharmaceutical products and medical supplies in Egypt (the “Decree”), this update covers the EDA’s new Decree No. 475 of 2025 (the “Complementary Decree”). The Complementary Decree establishes a national electronic system for tracking pharmaceutical products.

Highlights

On 11 August 2025, the EDA issued the Complementary Decree establishing a national track-and-trace system for human pharmaceutical and biologoical products, covering all stages of commercialisation (from production, importation and warehousing through to dispensing, exportation or destruction) (the “Track-and-Trace System”).

Scope of Application

The Complementary Decree applies to locally manufactured and imported human pharmaceutical and bioloigical products under the EDA’s jurisdiction.

It also extends to all entities involved in the production, importation, distribution, or storage of such products in Egypt, including pharmaceutical companies, factories, warehouses, distributors, and pharmacies (“Entities”).

Key Provisions

• The Track-and-Trace System requires every pharmaceutical or biological product package to carry a unique identifying number containing, at a minimum, the data to be specified by the Complementary Decree’s regulatory guide (yet to be issued).
• All Entities involved in the pharmaceutical supply chain must connect to the Track-and-Trace System, ensuring that every pharmaceutical or biological product is listed and electronically traceable. In this respect, Entities must have the necessary technical infrastructure, including (without limitation) printers, scanners, and compatible software.
• Compliance becomes mandatory on 1 February 2026 for the fully finished imported human pharmaceutical products, and on 1 August 2026 for bulk imported and locally manufacterd products (“Deadlines”). Post the Deadlines, no pharmaceutical products may be commercialised unless registered in the Track-and-Trace System.

Relevant Regulatory Guide

• A regulatory guide is expected to be issued within one (1) month from the Complementary Decree’s publication. The guide will specify all requirements for implementation of the Complementary Decree’s and will be updated as necessary.

The contributors to this article are Fadila Abdelaziz, Counsel, Fagr Moheb, Managing Associate and Youssef Ahmed, Junior Associate.