Highlights
On 29 April 2025, the Chairman of the Egyptian Drug Authority (“EDA”) issued Decree No. 161 of 2025 (the “Decree”), introducing a mandatory unified coding system for pharmaceutical products (“Pharmaceuticals”) and medical supplies (“Medical Supplies”) circulated within the Egyptian market.
Scope of Application
The Decree applies to all Pharmaceuticals and Medical Supplies under the jurisdiction of the EDA, whether locally manufactured or imported (fully finished or in bulk).
It also extends to all entities involved in the production, importation, distribution, or storage of such products, including pharmaceutical companies, factories, warehouses, distributors, and pharmacies (“Entities”).
Key Provisions
Entities are required to adopt a unified goods and services coding system for Pharmaceuticals, using unique 2D barcodes aligned with international standards. Each code must include the following data:
Regarding Medical Supplies circulated within the Egyptian market through the ‘Me Device’ online platform, the Decree amends Article 1 of EDA Decree No. 499 of 2021. It replaces the previously mandated use of GTIN‑based barcodes by the Entities with requirement to implement a unified goods and services identification system approved by any of the IMDRF-recognised organisations.
Pharmaceuticals and Medical Supplies may not be circulated within the Egyptian market unless registered under one of the approved unified goods and services coding systems. This coding requirement is mandatory but does not fall under the registration or listing requirements of these products before the EDA.
Implementation and Regulatory Guidance
The Decree supersedes any existing regulations or provisions that conflict with its terms.
It comes into effect the day following the publication of the EDA’s regulatory guide, which is expected within fifteen (15) working days from the Decree’s issuance. This guide will cover the detailed enforcement mechanism of the Decree.
Conclusion
This landmark Decree represents a significant step towards modernising Egypt’s pharmaceutical supply chain and aligning it with global traceability standards. It is also expected to greatly enhance the EDA’s ability to supervise trading channels, improving patient safety and reducing the risk of counterfeit products as well as parallel trade.
The contributors to this article are Fadila Abdelaziz, Counsel, Fagr Moheb, Managing Associate, and Sara Elzayat, Junior Associate.
For further inquiries, please contact our Life Sciences team members Mohamed Abdelgawad, Partner, Head of General Corporate, Commercial, and Regulatory, Fadila Abdelaziz, Counsel, Fagr Moheb, Managing Associate, and Nada Haggag, Associate.
