
Insights into Egypt’s New Regulations on Pharmaceutical Expiration and Returns
Q: What is Decree 39 of 2025 issued by the Egyptian Drug Authority?
A: Decree 39 of 2025 is a regulation issued by the Egyptian Drug Authority (EDA) on February 13, 2025 setting specific guidelines for the importation and handling of medical and biological products in the Egyptian market to safeguard public health and achieve pharmaceutical security in Egypt.
Q: What is the main purpose of Decree 39 of 2025?
A: The decree prohibits the importation of fully finished medical and biological products, or those intended for packaging within Egypt, if their shelf life is less than two-thirds of the total shelf life printed on the product’s packaging.
Decree 39 of 2025 aims at ensuring the safety, quality, and efficacy of medical and biological products in the Egyptian market. By regulating the importation and handling of these products, the decree aims to safeguard public health and achieve pharmaceutical security in Egypt.
Q: How is the shelf life of medical products calculated under this decree?
A: The shelf life considered for allowing the release and distribution of the product is calculated from the date the shipment arrives at Egyptian ports. This ensures that the products have a sufficient remaining shelf life to be safely used by consumers.
Q: Are there any exceptions to the shelf life requirement?
A: Yes, there are exceptions for emergency situations. In such cases, the import and distribution of medical and biological products that do not meet the shelf life requirement may be allowed. This exception requires a detailed technical memorandum supported by reasons and market studies, prepared by the Central Administration for Pharmaceutical Policies and Market Support, and approved by the head of the authority.
Q: When does Decree 39 of 2025 come into effect?
A: Decree 39 of 2025 will come into effect on July 1, 2025. It will be published in the Egyptian Gazette, and any conflicting provisions will be repealed.
Q: How should pharmaceutical manufacturing and distribution companies comply with this decree?
A: Pharmaceutical manufacturing and distribution companies should ensure that any medical and biological products they import into Egypt have a shelf life of at least two-thirds of the total shelf life printed on the product’s packaging. They should also be prepared to provide detailed technical memoranda and market studies in case of emergency situations where exceptions to the shelf life requirement are needed. Compliance with the decree will be monitored by the Egyptian Drug Authority, and companies should stay informed about any updates or changes to the regulations.
For more information or questions about this topic, please feel free to contact Dr. Fatma Salah.