Introduction

Further to our previously published update on Egyptian Drug Authority (the “EDA”) decree no. 161 of 2025 governing the unified coding of pharmaceutical products and medical supplies in Egypt (the “Decree”), and the publication regarding the complementary decree no. 475 of 2025 (the “Complementary Decree”) regarding the establishment and operation of a national system for tracking human and biological pharmaceutical products (“System”); the EDA issued Decree No. 804 of 2025 on 18 December 2025, which sets out the Complementary Decree’s implementation guidelines governing the operation of the System (“Guide”).

Scope of Application and Exclusions

1. The Guide applies to entities operating in the pharmaceutical sector in Egypt, including producers, distributors and warehouses, importers, logistics service providers, marketing authorisation holders, and all pharmaceutical institutions set forth under Article 10 of the Pharmacy Law No. 127 of 1955 (“Entities”).
   
2. Certain pharmaceutical products are excluded from the Guide’s application, including:
   i) unregistered imported products imported upon the request of specific individuals or entities,
   ii) products dedicated to clinical trials, and;
   iii) free medical, research, and study samples.

It should be noted that each of the above exclusions remains subject to the relevant regulatory controls applicable thereto.

Key Provisions

Purpose

The System is designed to electronically record and track each pharmaceutical product pack across its full supply chain, starting from manufacturing and importation up to dispensing to the patient, using international standards, notably the Electronic Product Code Information Services (“EPCIS”). The System aims to ensure transparency and product safety.

Major Obligations

1. All Entities must, among others:
   
   i) maintain activated accounts on the System;
   ii) update their data and obtain and maintain a separate location code per logistics point, being the iii) geographical location, and notify the EDA accordingly as per the timelines announced on the EDA’s official website;
   iv) use solutions and technologies compatible with the System, relying on EPCIS;
   consistently follow up on the EDA’s relevant technical and regulatory updates, and;
   v) fully comply with the Guide’s requirements.
   
2. Local manufacturers must, among others, serialise each pharmaceutical product pack and notify the EDA accordingly. In addition, they must print a 2D Data Matrix on the pharmaceutical product’s outer pack including the pharmaceutical product’s code, serial number, expiry date and batch number. Further, they shall link individual packs to higher packaging units using Serial Shipping Container Code (“SSCC”).
   
3. Toll manufacturers must also comply with the System’s technical and regulatory requirements.
   
4. Importers must, among others, ensure imported packs have the required serialisation including the pharmaceutical product’s code, serial number, expiry date and batch number. In addition, they must ensure that a 2D Data Matrix is printed on each pharmaceutical product’s outer pack.
   
5. Distributors/warehouses must, among others, record pharmaceutical products’ receipt and shipment from manufacturers and importers, using verified SSCC and location codes.
   
6. Public and private pharmacies must, among others, use compliant solutions with the System, relying on EPCIS. They must also record pharmaceutical products’ receipt, integrating the same with verified SSCC and location codes. In addition, they must verify pharmaceutical products’ valid tracking codes prior to dispensing them and further refrain from dispensing any pharmaceutical product with unverifiable coding, while notifying the EDA accordingly.
   
7. Hospitals must, among others, use solutions compliant with the System, relying on EPCIS. Moreover, they must record pharmaceutical products’ receipt, integrating the same with verified SSCC and location codes. Additionally, they shall verify pharmaceutical products’ valid tracking codes prior to dispensing them and further refrain from dispensing any pharmaceutical product with an unverifiable coding, while notifying the EDA accordingly.

Timeline

1. The System shall apply as follows:
i) on imported fully finished pharmaceutical products: as of 1 February 2026; and,
ii) on primary and/or secondary bulk imported and locally manufactured pharmaceutical products: as of 1 August 2026.

This is subject to the System implementation timeline issued by the EDA’s chairman.
Pharmaceutical products produced or imported by, maximum, the above-mentioned dates shall remain on the market until consumption.

2. Pharmaceutical products produced or imported by, maximum, the above-mentioned dates shall
remain on the market until consumption.

Non-Compliance Consequences

The EDA’s inspection department may take legal measures, including seizure, destruction of pharmaceutical products, written warnings with correction deadlines, temporary suspension of trading and importation, and the imposition of fines, against infringing pharmaceutical products set forth under Article 5 of the Complementary Decree, that are produced or imported after 1 February 2026 and 1 August 2026, as applicable.

The contributors to this article are: Fagr Moheb, Senior Associate and Alaa’ Elmekhashen, Junior Associate.