Subject Matter

On 13 February 2025, the Chairman of the Egyptian Drug Authority (“EDA”) issued Decree No. 39 of 2025 (the “Decree”), which imposes restrictions on the expiry dates and shelf lives of imported pharmaceutical and biological products.

Scope of Application

The Decree applies to all pharmaceutical and biological products imported into Egypt (the “Territory”), including both finished products and those intended for packaging and labelling within the Territory (“Imported Products”).

The Decree will come into effect on 1 July 2025 (the “Effective Date”), repealing any existing regulations or provisions that conflict with its terms.

Key Provisions

• The shelf life of Imported Products must be no less than two-thirds of the total shelf life indicated on their packages.
• The shelf life considered for the release and commercialisation of Imported Products will be calculated from the date their shipment arrives at the Egyptian ports.
• Notwithstanding the above, the release and commercialisation of certain Imported Products may be exempted from the Decree’s restrictions in cases of emergency. Such an exemption must be based on a detailed, reasoned technical memorandum supported by market studies, prepared by the Central Administration for Drug Policies and Market Support and further certified by the Chairman of the EDA.

Conclusion

The Decree’s subject matter complements the EDA’s recent Decree No. 47 of 2025 on the recall of expired pharmaceutical and biological products, with both aiming to enhance control over the Egyptian pharmaceutical market, ensuring greater stability and reliability.

It is important to note that the anticipated positive impact of such regulations depends on the cooperation of relevant stakeholders to ensure effective enforcement.

The contributors to this article are Fagr Moheb, Managing Associate and Hannah Mahran, 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 Hagag, Associate.