Executive summary

Ministerial Decree No. 22 of 30 September 2025 (Decree) governs the licensing process for wholesale distributors of pharmaceutical products and medical devices, including:

• Documents required to apply for licensing
• Administrative and technical review procedures
• Rules governing modifications, renewal and withdrawal of licenses

The Decree also introduces a mandatory compliance charter (cahier des charges) signed by both the Technical Pharmacist Director and the General Manager, confirming adherence to Good Distribution and Storage Practices.

Decree No. 22 repeals the provisions of the Ministerial Decree of 5 October 2021, modernizing the application process by introducing electronic submissions, defining administrative and inspection timelines and clarifying the treatment of substantial modifications and renewal conditions.

Key provisions

Application process

Applications must be submitted electronically by the Technical Director Pharmacist. The application file includes all corporate, legal and technical documents, including:

• The completed application form
• Justification of the royalty payment
• A copy of the establishment bylaws
• A copy of the establishment's trade register
• Proof of premises ownership or lease agreement
• The establishment's overall architectural plans at a 1/100 scale, prepared by a certified architect, specifying the description of the premises; total area must include storage areas, order preparation areas and administrative offices
• The list of pharmaceutical products or medical devices intended for importation
• The establishment's organizational chart
• The recruitment forecast plan by job category
• A copy of the identity document(s) of the general manager(s)
• A copy of the diploma and identity document of the Technical Director Pharmacist
• A registration certificate with the Pharmacists' Ethics Council or a receipt confirming submission of the registration file
• A certificate attesting that the Technical Director Pharmacist has at least one year of professional experience in the pharmaceutical sector

Note that only complete applications are accepted. Acknowledgment of receipt and a decision on admissibility must be issued within five days to the establishment by the competent services at the level of the Ministry of the Pharmaceutical Industry (Ministry).

Administrative review and inspection

Once the application is deemed admissible, the Ministry conducts an administrative review within eight days. The Ministry then sends a formal inspection request to the National Agency of Pharmaceutical Products (NAPP), which performs a site inspection within 30 days to assess compliance with Good Distribution and Storage Practices.

The NAPP inspection report is submitted to the Ministry and reviewed by a Technical Commission, which may seek expert input before making a final recommendation.

Decision and validity

The Minister of the Pharmaceutical Industry must issue a decision within two months of receiving a complete file.

The license is valid for two years, renewable under the same conditions. It specifies the company's legal identity, sites, responsible persons and approved activities.

The Technical Director Pharmacist also receives a renewable two-year authorization to practice.

Modifications and renewal

Substantial modifications are major changes that impact the wholesale distribution and storage operations of the licensed pharmaceutical establishment. These substantial modifications are subject to prior authorization from the Minister of the Pharmaceutical Industry.

The pharmaceutical establishment is required to declare any substantial modification to the competent services of the Ministry, through a secure electronic system, within a period not exceeding 15 days. Non-substantial changes (e.g., company name, legal form, management changes) must be declared within 15 days of the change. The Ministry processes requests for substantial modifications within two months.

Renewal applications must be filed four months before expiry, accompanied by proof of compliance and occupancy.

Withdrawal and compliance obligations

Establishments must notify the Ministry electronically if they voluntary cease activity.

Note that failure to comply with regulations or to address inspection deficiencies may lead to license withdrawal after formal notice.

Moreover, the decree requires pharmaceutical establishments to maintain a minimum 30-day stock of essential medicines and medical devices to ensure continuous supply to pharmacies, hospitals and other healthcare institutions. They must also cover at least two-thirds of the national list of pharmaceutical products. Furthermore, all wholesale distributors that were already authorized at the time of the decree's publication must update their licensing documentation to comply with the new requirements within 12 months.

Implications

Entities operating in the pharmaceutical distribution sector should prepare for the new licensing process, ensure their documentation is complete, and be aware of the potential for license withdrawal due to noncompliance with the new regulations.