February 14, 2025

Q&A on the New Rules for Handling Expired Pharmaceuticals

Introduction

The Egyptian Drug Authority (EDA) has recently issued Decree No. 47 of 2025 (Decree), a pivotal regulation aimed at enhancing the management of expired pharmaceutical products. The Decree establishes clear procedures for the withdrawal, return, and destruction of expired products. This article will delve into the key provisions and implications of Decree No. 47 of 2025, providing a comprehensive overview for stakeholders in the pharmaceutical industry.

Q: What is Decree No. 47 of 2025 about?

A: Decree No. 47 of 2025, issued by the Egyptian Drug Authority (EDA), outlines the procedures and regulations for the withdrawal of pharmaceutical products upon the expiration of their validity. The goal is to ensure the safety, quality, and efficacy of medical and biological products in the Egyptian market, thereby safeguarding public health and achieving pharmaceutical security.

Q: What are the key terms defined in this Decree ?

A: Here are some important definitions to know:

  • Law: Refers to the Law on the Establishment of the Egyptian Drug Authority, Law No. 151 of 2019.
  • Executive Regulations: The rules issued by the Prime Minister’s Decree No. 777 of 2020.
  • Authority: The Egyptian Drug Authority itself.
  • Products: Medical and biological products as defined in Law No. 151 of 2019.
  • Handling: Any process involving the production, distribution, possession, sale, storage, use, packaging, transportation, delivery, import, or export of products.
  • Pharmacies: Licensed pharmaceutical institutions under Law No. 127 of 1955, including both public and private pharmacies.
  • Warehouses and Stores: Licensed pharmaceutical institutions under Law No. 127 of 1955.
  • Companies: Entities operating in the Egyptian pharmaceutical market, including manufacturers, distributors, importers, and those with licensed warehouses and stores.
  • Shelf Life: The period during which a product can be consumed while retaining its properties, provided it is stored correctly.
  • Expiration Date: The predetermined date after which a product should not be consumed due to potential changes in its properties, loss of efficacy, or spoilage.
  • Supply Chain: The process from the manufacturer or importer to the pharmacy, including storage and distribution.
  • Unit of Production: The final form of the product available for sale to the public.
  • Compensation for the Product: The net amount paid by the pharmacy after deducting the value of free samples from the total invoice, used to calculate financial or in-kind settlements.

Q: What must companies do with expired products they produced or imported?

A: Companies have specific responsibilities regarding expired products:

  • Accept Returns: Companies must accept returns of expired products they produced or imported, in the smallest production units, from pharmacies, warehouses, or stores within 90 days from the effective date of the Decree.
  • Sort and Settle: Returned products must be sorted within 30 days of receipt, and compensation must be settled within 180 days from the effective date of the Decree.

Q: How are expired products destroyed?

A: The destruction process is as follows:

  • Factories: Must destroy returned products within 40 days of receipt.
  • Importing Companies and Contract Manufacturers: Must destroy their returned products within 40 days of notification by the warehouse or store.
  • Compliance: The destruction must comply with the law, executive regulations, and applicable procedures.

Q: What happens if companies do not comply with these regulations?

A: Companies that fail to comply with the Decree will be reported to the Head of the Central Operations Department for appropriate legal action.

Q: What are the obligations of pharmacies under this Decree?

A: Pharmacies have their own set of rules:

  • Destroy Expired Products: Pharmacies must destroy expired products under the supervision of the Egyptian Drug Authority inspectors, at their own expense.
  • Accept Returns: After the 90-day period, companies must accept returns of products with at least six months of remaining shelf life, provided the original invoice is presented.

Q: How will the implementation of this Decree be monitored?

A: Monitoring will be done through:

  • General Committee: A general committee, chaired by the Head of the Central Operations Department, will monitor the implementation of this Decree. It will include representatives from the General Syndicate of Pharmacists, the Chamber of Pharmaceutical Industry, the Chamber of Commerce, and relevant associations.
  • Sub-committees: These will be established in all governorates, chaired by the local branch manager of the Authority, to monitor the implementation and report to the general committee.

Q: When does this Decree take effect?

A: This Decree will be effective from the day following its publication in the Egyptian Gazette and will override any conflicting provisions.

That’s all for now on Decree No. 47 of 2025! Stay tuned for more updates and make sure your practices align with these new regulations.

For more information or questions, please fee free to contact Dr. Fatma Salah.

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