The Egyptian Drug Authority’s Decision No. 162 of 2026 was published in Al-Waqa’i Al-Misriyya, Issue No. 243, on 2 November 2026.
The decision provides for:
Prohibiting the circulation of medical or biological products manufactured or imported without registration in the Unified National Electronic Pharmaceutical Track AND Trace System, according to the schedules and deadlines issued by the EDA for each product or group of products.
Requiring licensed importers of finished medical and biological products, as well as licensed pharmaceutical manufacturers, to apply the unified code using unique identification numbers to each pack or sales unit, according to EDA schedules.
Requiring administrative entities receiving products through the Egyptian Authority for Unified Procurement to ensure that products carry the required code and are registered in the system. Compliance dates set by the procurement authority must not exceed EDA registration deadlines.
Allowing manufacturers and importers to apply for registration ahead of the scheduled deadlines, subject to meeting technical requirements and approval by the EDA Chairman.
Permitting non-removable labels bearing the required code instead of direct printing, subject to EDA specifications and an application explaining the justification, duration and number of batches concerned.
Allowing the EDA Chairman to grant additional time under specified conditions, including where products are listed as being in shortage or an extension is necessary to meet local market needs.
The decision takes effect on the day following publication. Product-specific compliance remains subject to the schedules and deadlines issued by the relevant authorities.
Full decision attached: Al-Waqa’i Al-Misriyya, Issue No. 243, pages 24–27.
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