Pharmaceutical Warehouses New Compliance Requirements
On December 22, 2024, Egypt’s government issued Decree No. 725 of 2024 concerning the Conditions and Procedures for Licensing Pharmaceutical Warehouses. This long-awaited legislation follows a six-month suspension of new licenses for pharmaceutical warehouses and introduces enhanced compliance standards, including mandatory adherence to Good Storage and Distribution Practices (GSDP).
The Egyptian Drug Authority (EDA) is expected to release detailed guidelines within 10 days of the Decree’s publication, supplementing the general health requirements applicable to all pharmaceutical entities.
Licensing and Renewal Requirements
Under the Decree, all pharmaceutical warehouses must obtain an EDA license to store, handle, or sell pharmaceutical products in bulk. Key licensing provisions include:
- Licenses are valid for five years and must be renewed within the final six months of the fifth year. Failure to renew on time will result in administrative closure of the warehouse.
- Warehouses with licenses already exceeding five years must submit renewal requests no later than January 1, 2026, to avoid closure.
Operational and Transactional Regulations
The Decree sets forth specific rules for warehouse operations, including procurement, recordkeeping, and restrictions on sales and distribution.
Product Acquisition
Warehouses may acquire pharmaceutical products only from:
- EDA-licensed manufacturers
- EDA-registered importers
- Other GSDP-certified warehouses
Recordkeeping and Invoicing
- Transactions must be documented with invoices and recorded in both inbound and outbound registers.
- All invoices must be electronically stored, including details of the buyer and seller.
- Sale documents must be retained for five years.
Sales and Distribution Restrictions
- Warehouses are prohibited from selling products directly to the public.
- Distribution is restricted to the warehouse’s licensed geographical area.
- Discounts or other sales facilitations require prior EDA approval and are limited to products permitted for free circulation.
Suspension of Supply Between Warehouses
To maintain pharmaceutical security, the Head of Central Operations Management may suspend product supply between warehouses, limiting it to pharmacies for up to six months (renewable), based on technical reports.
Reporting and Compliance Inspections
Reporting Obligations
- Warehouses must report unavailable products within one month of their unavailability.
Inspections and Non-Compliance
- Warehouses are subject to routine and dawn raids. Violations such as the storage of expired, smuggled, counterfeit, or unregistered drugs may result in:
- Administrative closure
- Destruction of defective products
- Application of criminal liability
The Decree empowers the Head of Central Operations Management to restrict a warehouse’s dealings to specific entities for up to six months in cases of non-compliance.
Prohibited Practices
The Decree explicitly prohibits the following practices:
- Storing vitamins without prior EDA approval.
- Storing medications or products not contracted for distribution.
- Leasing warehouse spaces to third parties.
Strengthening the Regulatory Framework
Adherence to Decree No. 725 of 2024 is critical for avoiding administrative penalties and supporting a secure and efficient pharmaceutical distribution system. The continued oversight of the EDA will play a pivotal role in upholding these standards and fostering trust in the industry.
For further guidance on compliance with Decree No. 725 of 2024, please do not hesitate to contact us.
