You are currently viewing Newsflash: El Salvador – ENTRY INTO FORCE OF THE SUPERINTENDENCE OF SANITARY REGULATION

Newsflash: El Salvador – ENTRY INTO FORCE OF THE SUPERINTENDENCE OF SANITARY REGULATION

The National Directorate of Medicines (DNM) informed that it will be transformed into the Superintendence of Sanitary Regulation (SRS, by its Spanish acronym) as of August 7.

With the enactment of the Superintendence of Health Regulation Act, published in the Official Bulletin on December 4, 2023, the SRS will be the National Regulatory Authority for medicines, nutritional supplements, medical devices and equipment, other health technologies, cosmetics, hygiene products for human and veterinary use, chemical products, food, beverages in general, alcohol, tobacco, nicotine-releasing devices or similar without nicotine, taking over some roles from the Ministry of Health and the Ministry of Agriculture and Livestock of El Salvador.

The entity will regulate sanitary registration and grant authorizations for commercializing such products. Based on the new regulations, the SRS will update the institutional framework and centralize these competencies in a single entity, under international norms and standards.

The creation of the SRS also includes that of the following departments: a) Department of pharmaceuticals and related products; b) Department of food, beverages and related products; c) Department of agriculture and related products; and d) Department of Oversight. These will have the authority to grant sanitary registrations, recognition of sanitary registrations, marketing authorizations, as well as control and oversight, including the imposition of sanctions and fines.

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