No Licenses for Pharmaceutical Companies Without Settlement of Tax Dues

Pharmaceutical companies will soon be required to submit a tax clearance certificate with all files lodged with the National Agency for Pharmaceutical Products, as a condition for administrative acceptance. The measure aims to ensure the settlement of outstanding tax obligations owed to the Public Treasury.

The measure applies to applications for the registration of pharmaceutical products, the approval of medical devices, and the renewal, amendment, or transfer of registration and approval decisions. It also covers advertising visas, their renewal, and all licenses or regulatory procedures subject to fees. A three-month grace period has been granted to allow companies to regularize their tax situation before the certificate becomes fully mandatory for the acceptance of any file.

In this context, the Ministry of Pharmaceutical Industry issued Directive No. 44/26, dated May 18, 2026, instructing all pharmaceutical manufacturers to include a tax clearance certificate confirming payment of duties in every file submitted to the National Agency for Pharmaceutical Products to obtain an administrative acceptance.

According to the directive, this measure is part of the implementation of the provisions of Order No. 21-07 of June 8, 2021, concerning the Supplementary Finance Law for 2021, as well as Law No. 24-08 of November 24, 2024, concerning the Finance Law for 2025, particularly the provisions related to payments due to the Public Treasury.

The directive clarified that the requirement applies to all files submitted to the National Agency for Pharmaceutical Products, including: Applications for the registration of pharmaceutical products, applications for the approval of medical devices, requests for the renewal, amendment, or transfer of registration or approval decisions,applications for advertising visas and their renewal, applications for licenses and any other regulatory procedures subject to fees under the applicable legislation.

The document emphasized that all relevant files must include a tax clearance certificate issued by the Finance and Accounting Directorate of the National Agency for Pharmaceutical Products. The certificate is now considered a mandatory document for the administrative acceptance of files.

It further stated that any file submitted without this certificate will be deemed inadmissible and will not be processed by the competent departments of the National Agency for Pharmaceutical Products.

However, the directive provides for a transitional period of three months from the date of issuance, allowing pharmaceutical operators time to settle their outstanding tax obligations. During this period, files may still be submitted without the certificate, provided that the company regularizes its situation within the prescribed deadlines.

The directive indicated that, after the expiration of this grace period, submission of the tax clearance certificate will become a mandatory requirement for the acceptance of any file, stressing the importance of strict compliance to the provisions of this directive.

In a press release, the National Agency for Pharmaceutical Products announced that guidelines on regulatory trust and mutual recognition practices in Good Manufacturing Practices (GMP) inspections are now available on its website as part of its efforts to enhance transparency and facilitate access to approved regulatory standards.

According to the agency, this initiative will strengthen regulatory trust between supervisory authorities by promoting the principle of mutual recognition in GMP inspections. This approach is expected to accelerate the review and approval process for pharmaceutical products while maintaining quality and safety standards.

The agency added that the measure will also improve the efficiency of the regulatory system by reducing duplicate inspections and harmonizing evaluation criteria, thereby facilitating administrative procedures and accelerating the introduction of pharmaceutical products to the market.

Finally, this measure reflects the Algerian authorities’ broader efforts to strengthen governance and transparency within the pharmaceutical sector. In recent years, Algeria has accelerated reforms aimed at modernizing the regulatory framework, encouraging local pharmaceutical production, improving the monitoring of imported products, and reinforcing compliance with international quality standards. These initiatives are intended to support the development of a more structured and competitive pharmaceutical industry while ensuring the availability, safety, and quality of medicines and medical devices on the national market.