On March 24, 2021, the Law No. 1068 “Law for the Creation of the National Authority for Sanitary Regulation” came into force in Nicaragua, by its publication in the edition No. 58 of La Gaceta-Diario Oficial. The purpose of the Law is the creation of the National Authority for Sanitary Regulation (NASR), legal successor without continuity solution of the General Directorate of Sanitary Regulation for Health of the Ministry of Health (MINSA).
According to the Law, the NASR is now in charge of the control and regulation of matters related to health, which until now had been competence of the General Directorate of Sanitary Regulation or Health of MINSA. Mainly, the NASR will be in charge of facilitating, regulating, implementing, developing and coordinating the policies, laws, regulations and related standards with the sanitary authorizations, surveillance, promotion, advertising, control and supervision of: medicines (formula milk and breast milk substitutes), vaccines, biological, biotechnological, medicinal natural products and homeopathic; food and beverages; nutritional supplements; medical devices and other technologies related to health; all related to ionizing radiation; precursor chemicals; cosmetic and hygienic products; tobacco and its derivatives as well as the regulation and control of donations, medical brigades, medical and non-medical supplies and supervision of health, pharmaceutical and food establishments, as well as audits on the quality of health care, establishments that provide health services , pharmaceutical and food establishments that provide disinfection, structural or residential sanitation services with pesticides, toxic substances, precursors or similar, which may have an impact on health.
Although the law does not establish any change in the requirements and procedures related to health registration of products and authorization of establishments, which until now remain the same, it is established that one of the functions of the NASR will be the preparation and approval of regulations, standards and administrative provisions in health matters; which leaves open the possibility that said authority in the future may modify the regulatory framework in this matter.
Also, the law establishes the possibility of creating official fees for services provided by the NASR and its agencies, which would mean the creation of new official fees for services that to date are provided by the General Directorate of Sanitary Regulation of MINSA. Said official fees will be approved through the approval and publication of the regulation of the Law for the Creation of the National Authority for Sanitary Regulation.