Subject Matter

On 13 February 2025, the Chairman of the Egyptian Drug Authority (“EDA”) issued Decree No. 47 of 2025 (the “Decree”), followed by an enforcement guideline, mandating pharmaceutical companies to recall all expired pharmaceutical and biological products (“Expired Products”) through pharmacies and warehouses (“Distributors”)

Scope of Application

The Decree, which came into force on 14 February 2025 (“Effective Date”), applies to all Expired Products on the market.

Key Provisions

• Expired Products must be returned to their manufacturing, toll, or importing pharmaceutical companies (“Pharmaceutical Companies”) through Distributors, as part of the process known as the “Recall Process”, which is mandated by the Decree. This includes the proper destruction of such Expired Products.
• The Decree’s scope does not affect existing contractual arrangements or commercial customs.
• The timeframe for the Recall Process and the destruction of Expired Products is as follows:
  1. The Recall Process must take place within ninety (90) days from the Effective Date.
  2. Returned Expired Products must be sorted within thirty (30) days of their receipt by the Pharmaceutical Companies.
  3. Compensation for returned Expired Products must be processed within one hundred and eighty (180) days of the Effective Date.
  4. Manufacturing Pharmaceutical Companies must destroy returned Expired Products within forty (40) days of their receipt.
  5. Returned Expired Products must be destroyed by the toll and importing pharmaceutical companies within forty (40) daysof the Distributor notifying them of the receipt of the returned Expired Products.
• A committee shall be established by the EDA, chaired by the Head of the EDA’s Central Operations Administration, and will include recommended experts and representatives from:
  • the Pharmacists Syndicate;
  • the Chamber of Pharmaceuticals Industry;
  • the Chamber of Commerce; and
  • relevant specialised committees and departments.
• The committee will oversee and facilitate the Decree’s enforcement. Additionally, relevant subcommittees will be established across all governorates to ensure the Decree’s implementation.
• The destruction of Expired Products must comply with the law and be supervised by the EDA’s inspectors. In this regard, Pharmaceutical Companies must submit a destruction request to the EDA’s Markets Control Department within ten (10) days of completing the return of Expired Products.
• Pharmaceutical Companies failing to implement the Decree will be reported by the distributors to the Head of the EDA’s Central Operations Administration through the official online portal provided by the EDA, for appropriate legal action to be taken.
• Upon the completion of the Recall Process timeframe, Pharmaceutical Companies must accept returns of their products with a remaining shelf life of at least six (6) months, provided the products are returned with the relevant invoices. The remaining shelf life of the pharmaceuticals must be six (6) months at the time of the return request submission.

Enforcement Mechanism

• Pharmacies’ Obligations:
  1. Inventory Expired Products and upload their data to the official online portal provided by the EDA, specifying the relevant Distributors and attaching relevant invoices, if available; and
  2. stamp the Expired Products to be returned to the relevant Distributors (“Returns”) with the pharmacy’s stamp.

• Distributors’ Obligations:
  1. Receive a statement of the Returns directed to them;
  2. prepare a weekly schedule of the pharmacies involved in the Recall Process and share the same with the EDA;
  3. receive the Returns using the receipt template provided by the EDA and keep a copy;
  4. upload the data of received Returns to the official online portal provided by the EDA prior to examining, stocking, and returning  them to the relevant Pharmaceutical Companies.
  5. provide the EDA with weekly updates on received and delivered Returns to the Pharmaceutical Companies.

• Pharmaceutical Companies’ Obligations:
  1. Receive a statement of the Returns directed to them;
  2. prepare a weekly schedule of recalling Returns received from Distributors and update the EDA accordingly;
  3. upload the data and quantity received, examined, and sorted Returns to the official online portal provided by the EDA; and
  4. receive Returns using the receipt template provided by the EDA, share the original copy with the relevant Distributor, and keep a copy with the Distributor’s stamp.

Conclusion

The subject matter of the Decree complements the EDA’s recent Decree No. 39 of 2025, which imposes restrictions on the expiry date and shelf life of imported pharmaceutical and biological products. Both decrees aim to enhance control over the Egyptian pharmaceutical market, ensuring greater stability and reliability.

It is important to note that the anticipated positive impact of these regulations depends on the cooperation of relevant stakeholders in securing a proper enforcement.

For further inquiries, please contact our team members Mohamed Abdelgawad, Partner, Head of General Corporate, Commercial, and Regulatory, and Fagr Moheb, Managing Associate, and Nada Haggag, Associate.