Published on April 10, 2021

Nicaragua : Law No.1068 that creates the National Authority of Sanitary Regulation


This Law creates the National Health Regulation Authority(ANRS), "as a public entity with legal personality, its own assets,technical and administrative autonomy, attached to the Ministry of Health, withfull capacity to acquire rights and incur obligations in matters within itscompetence and will be the legal successor without interruption of the GeneralDirectorate of Health Regulation".

The objective of this entity will be to "facilitate, regulate, implement, develop and coordinate the policies, laws, regulations andnorms related to the sanitary authorizations, surveillance, promotion,advertising, control and control of medicines (infant formula and breast milk substitutes), vaccines, biologicals, biotechnological products; naturalmedicinal and homeopathic products; food and beverages; nutritional supplements; medical devices and other technologies related to health; everything related to ionizing radiation; precursor chemical substances; cosmetic and hygienic products; tobacco and its derivatives. Likewise, the regulation and control of donations, foreign medical brigades, medical and non-medical supplies; regulation of the professional practice in health, audition the quality of health care, health service providers, pharmaceutical and non-pharmaceutical establishments, food establishments; establishments that provide disinfection services, structural or housing sanitation with pesticides, toxic, dangerous and other similar substances; and others that may have an impact on health". (Extracts from Articles 1 and 2)

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