The Legislative Assembly of El Salvador approved the Law of the Superintendence of Sanitary Regulation that consolidates the supervision of sanitary registrations for medicines, cosmetics, chemicals, food, beverages, alcohol, tobacco, nicotine devices, and agricultural inputs that are commercialized or imported into the country.

According to our lawyer, Fátima Espinal, the sanitary registration was under the responsibility of several institutions: the National Directorate of Medicines (DNM), the Higher Council of Public Health, the Ministry of Agriculture and Livestock (MAG), and the Ministry of Health, which will have to transfer assets to the Superintendence.

“This law will apply to all state institutions, including autonomous or decentralized ones, and to individuals or companies engaged in activities regulated by the law,” says Fátima.

Among the powers of the Superintendence are:

• Regulating the quality, efficacy, safety, and promoting the best price in the market for products.
• Granting sanitary registrations, recognizing registration, and authorizing the commercialization of products.
• Authorizing sanitary permits for import and export.
• Monitoring narcotics, psychotropics, additives, or chemical precursors.
• Registering chemicals and authorizing research projects.
• Keeping a record of professionals and representatives, managers, or responsible and dependent directors.
• Publishing a list of pharmaceutical specialties containing narcotics, psychotropics, or additives.
• Publishing a list of over-the-counter medications.

Regarding its organization and administration, the Superintendence will have a council and “four new intendancies dedicated to controlling the marketing of pharmaceuticals, chemicals, food, beverages, agricultural inputs, and psychotropic products” will be created, explains our lawyer.

Additionally, the legislation contemplates the transfer of assets, including both movable and immovable property, from entities such as the DNM, the Higher Council of Public Health, the Ministry of Health, and the Ministry of Agriculture and Livestock to the Superintendence, with the purpose of ensuring an effective transition. Likewise, issues related to the dissolution of personnel and the termination of contracts with suppliers of the affected institutions are addressed.

“This law would revoke certain elements of the Medicines Law related to the creation, powers, and structure of the DNM. The Superintendence would assume the responsibilities previously carried out by the DNM and other competent entities in the field of sanitary regulation,” Espinal states.