The National Directorate of Medicines (DNM) in El Salvador will have a new Special Law on Service Prices that has a significant impact on the pharmaceutical industry and related sectors.

This regulation, effective from January 1, 2024, aims to strengthen the regulation and control of products such as medicines, cosmetics, hygiene products, chemicals, nutritional supplements, medical devices, and clinical trials, among others. Our associate from the Tax and Compliance Department, Adalicia Torres, shares some important details.

Increase in Fees and New Quotas

One characteristic of the law is the increases in fees charged by the DNM to companies related to the mentioned products. The “Annual maintenance fee for market surveillance” is one of the most notable examples, with specific rates for different product categories. Adalicia explains that “it will be $100 for pharmaceutical products, $35 for cosmetic and hygiene products; $85 for medical devices and other healthcare technologies.”

Gradual Implementation of Fees

To mitigate the immediate financial impact of these changes, the new law establishes a gradual transition period. This means that companies will have time to adapt to the new fees before they are fully implemented. Our lawyer shares that the fees “will be applied and gradually increased by 50% starting January 1, 2024, 75% starting January 1, 2025, and 100% starting January 1, 2026.”

Exemptions and Maintenance Fee

The new law also includes exemptions for certain free health services, as well as procedures related to orphan drugs not available in the local market. Additionally, a “maintenance fee” has been introduced, which will apply to different pharmaceutical products and others. Adalicia believes that these exemptions are important to ensure that essential services remain accessible.

Impact on the Pharmaceutical Industry

Our expert assures that this new law can have a significant impact on the pharmaceutical industry and its stakeholders, including manufacturers, importers, and distributors. Adapting to the new fees and proper financial planning will be essential for long-term success in this sector.