The Egyptian Drug Authority (the “EDA”) has issued decree no. 612 of 2026 (the “Decree”), published in the Official Gazette, Issue No. 243, on 2 November 2026. The Decree has been in force since 3 November 2026. The Decree puts into effect the obligation to register medicinal and biological products on the National Unified Electronic Pharmaceutical Track-and-Trace System (the “Track-and-Trace System”), established under EDA Decree No. 475 of 2025. The EDA will set, in tables issued for each product or group of products, the deadlines by which products must be registered on the Track-and-Trace System and coded.
Medicinal and biological products, whether locally manufactured or imported, may not be circulated unless they are registered on the Track-and-Trace System. Registration must take place within the deadlines set in the EDA tables for each product or group of products. Companies should therefore follow the tables as they are issued and identify the deadline applicable to each of their products.
Companies licensed to import finished medicinal and biological products, and pharmaceutical factories licensed by the EDA, must add the unified code, based on unique identification numbers, to each pack or unit of sale, in line with the EDA tables. For imports, the EDA’s Central Administration for Pharmaceutical Policies and Market Support and its Central Administration for the Inspection of Pharmaceutical Establishments will coordinate on whether shipments meet the registration requirement under Article 1 of the Decree.
Administrative entities supplied through the Egyptian Authority for Unified Procurement, Medical Supply and Medical Technology Management (the “UPA”) may not circulate any product unless each pack carries the unified code and the product is registered on the Track-and-Trace System. The UPA sets the deadlines, which may not exceed the EDA’s registration deadlines for local or imported products.
Manufacturers and importers that meet the technical requirements for joining the Track-and-Trace System may apply to register their products before the deadlines in the EDA tables. The EDA’s Chairman decides each application based on a technical memorandum from the Central Administration for the Inspection of Pharmaceutical Establishments.
The Decree permits a non-removable label bearing the unified code to be used as an alternative to printing the code directly on the packaging or final sales unit, subject to the applicable EDA requirements and approval procedures.
An application must be submitted to the EDA’s Central Administration for the Inspection of Pharmaceutical Establishments and should state the reasons, with supporting documents, and the period and number of batches for which the label is needed. Labels are a temporary solution until the code is printed on the pack.
The EDA may grant an additional compliance period to an entity that has not satisfied the applicable requirements for joining the Track-and-Trace System within the deadlines in the EDA tables. The decision is based on a technical memorandum from the Central Administration for the Inspection of Pharmaceutical Establishments setting out the reasons, scientific evidence and market studies relating to the product. This extension is only available where the relevant product is on the applicable pharmaceutical shortage lists, or the extra time is needed to meet the demands of the local market. Any extension must specify the additional period granted to the relevant entity.
Disclaimer
This document is for informational purposes only and does not constitute legal advice.
The contributors to this article are Fadila Abdelaziz, Counsel – Head of Life Sciences; and Nada Haggag, Associate.
