Ley No. 1068, Ley Creadora de la Autoridad Nacional de Regulación Sanitaria (Law No. 1068, Law creating the National Health Regulatory Authority)

The purpose of the notified Law is to create the National Health Regulatory Authority, as a public entity with legal personality, its own assets and technical and administrative autonomy. The National Health Regulatory Authority is attached to the Ministry of Health and has full capacity to acquire rights and contract obligations concerning matters within its competence, and will be the uninterrupted legal successor of the Directorate-General of Health Regulation, established by Decree No. 25-2006 amending and supplementing Decree No. 71-98, Regulations implementing Law No. 290, Law on the Organization, Competence and Procedures of the Executive, published in La Gaceta, Official Journal Nos. 91 and 92 of 11 and 12 May 2006. It currently operates as the Directorate-General of Health Regulation in accordance with the institutional organizational chart. This entity will be known by the acronym ANRS and will be domiciled in the city of Managua.
The purpose of the ANRS will be to facilitate, regulate, implement, develop and coordinate policies, laws, regulations and standards concerning health authorizations, surveillance, promotion, advertising, control and inspection of: medicines (breast milk and breast milk substitutes), vaccines, biological and biotechnological products; natural homeopathic and medicinal products; food and beverages; nutritional supplements; medical devices and other health-related technology; all products relating to ionizing radiation; precursor chemicals; cosmetic and hygiene products; and tobacco and tobacco products. Its purpose will also be to: regulate and control donations, foreign medical brigades, medical and non-medical inputs; and regulate professional health practices, audits on the quality of health-care services, establishments providing health services, pharmaceutical and non-pharmaceutical establishments, food establishments, and establishments providing disinfection, structural or housing sanitation services using pesticides, toxic, hazardous and other similar substances; and others that may have an impact on health.