El Salvador Healthcare Fees

The law sets new service fees for pharmaceuticals, cosmetics and hygiene, medical devices, nutritional supplements, control substances, and chemical products.

On September 18, 2023, the Legislative Assembly approved the “Special Law on Fees of the National Medicine Directorate (DNM)”. The new law determines new rates for the services and other related activities offered by the DNM, including the registration of products, modifications post-registration, renewals, laboratory analysis, importation and exportation permits, importation permit for commercialization, promotion and publishing authorizations, inscription and authorization of functioning, audits for good manufacturing practices, among other services. In addition to the increase in fees, the law establishes new categories such as an annual fee for maintenance of surveillance in the marketplace that will be applied to all registered products, imported, or locally manufactured that are being commercialized in the country.  

The new fees apply to all pharmaceutical, cosmetic and hygiene, medical devices, nutritional supplements, control substances, and chemical products. 

All national public institutions, including the Salvadoran Social Security Institute, are exempt from paying the fees established by the law. NGOs with prior authorization of the DNM and registered at the Ministry of Governance, orphans, patients when the medicine is not available in the market, and importations for personal use when they don’t exceed the value of a minimum wage of the trade and services sector will also be exempt.

The new fees will enter into force on January 1st, 2024. However, renewals of the product sanitary registration and the annual fee for the maintenance of surveillance in the market will enter into effect gradually during the next three years: 50% on January 1, 2024; 75% on January 1, 2025; and 100% by January 1, 2026.

A full copy of the law is available in the Official Gazette. Date of Publication: October 6, 2023. 

For more information, contact the U.S. Commercial Service Office in San Salvador at  office.sansalvador@trade.gov.