Last March 11, 2021, the National Assembly of Nicaragua presented the initiative of the Law Creating the National Authority for Health Regulation "ANRS." According to the law, this new body is created as a decentralized entity with its legal regime and technical and administrative autonomy attached to the Ministry of Health.

The ANRS will have the functions currently performed by the General Directorate of Health Regulation, and its purpose is to facilitate, implement, develop and coordinate policies, laws, regulations, and norms related to health regulation. These include authorizing, promoting, advertising, controlling, and supervising controlled products such as medicines (including infant formula and breast milk substitutes); vaccines; biological and biotechnological products; natural and homeopathic products; food and beverages; nutritional supplements; medical devices and other health-related technologies; precursor chemicals; cosmetics and hygiene products; tobacco and its derivatives.

Additionally, the Authority will be in charge of the regulation and control of donations, medical brigades, medical supplies, the professional practice of health, public or private health service providers, pharmaceutical, food, sanitation, disinfection, and pesticide establishments, among others that may have an impact on health.

The organizational structure of the ANRS will be very similar to the one that the General Directorate of Sanitary Regulation currently has; 6 Directorates including the National Atomic Energy Commission (CONEA), and five support bodies. The official fees for the different procedures will be established in the Regulations to be issued under the Law after its approval.

It is expected that this initiative will be approved in the next few days and will become effective once it is published in the Official Gazette La Gaceta.

If you have any questions or would like more information on this matter, please do not hesitate to contact us.