El Salvador Superintendence for Sanitary Regulation

The law creates a new autonomous agency responsible for authorizing processes needed by U.S. companies interested in selling their products in El Salvador.

On November 14, 2023 the Legislative Assembly in El Salvador approved the Law of the Superintendence of Sanitary Regulation, which creates a new entity responsible for regulating, granting product registration, authorizing the commercialization, import and export permits, certifications, and surveillance for the following products: pharmaceuticals, medicines, nutritional supplements, medical devices and equipment, other health technologies,  cosmetics, hygienics, chemical products, food, food for special regimes, beverages in general, both for human use and veterinary use, alcohol, tobacco, nicotine delivery devices or similar without nicotine, and agricultural supplies. 

The Superintendence of Sanitary Regulation (SRS) will absorb the National Medicine Directorate (DNM), and some divisions currently under the Ministry of Health, and the Ministry of Agriculture.  The entity will be also responsible for authorizing and determining medicine prices in El Salvador. 

The law stated that the new SRS would start operating on April 1, 2024. However, on March 19, 2024, the Legislative Assembly approved a reform to extend the date of implementation until August 9, 2024. The law regulation is currently under development. 

A full copy of the law is available in the Official Gazette: Date of Publication: December 4, 2023. 

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