The law creating a new Nicaraguan health authority (Ley Creadora de la Autoridad Nacional de Regulación Sanitaria), approved by the National Assembly, has now been published in La Gaceta (Number 58, dated March 24th 2021), a formality that makes it law.
The National Authority for Health Regulation (ANRS by its acronym in Spanish) will succeed the General Directorate of Health Regulation for Health of the Ministry of Health (MINSA). It will be a decentralized institution and governing body attached to MINSA but with its own legal, technical and administrative autonomy.
The wide range of functions will include many of the tasks currently performed by the General Directorate of Health Regulation in the area of policies, laws, regulations, and procedures related to health regulation. They will also include; product approval, how products are promoted and advertised, products such as medicines, vaccines, biological and biotechnological healthcare products as well as natural and homeopathic medicines. Also; food and beverages, supplements, devices, health-related technology as well as chemicals, cosmetics, hygiene products, tobacco and its byproducts.
Another responsibility of the new Nicaraguan health authority will be the regulation and control of donations, foreign medical missions and medical supplies. Also the quality of professional healthcare practices (public and private healthcare providers) pharmaceuticals, food safety, sanitation and disinfection as well as pesticide establishments as being an example of any other products or supplies that may have an impact on health.
The law suggests that a total of five dedicated directorates will fall under the General Director of the ANRS. These will be pharmacy, quality control laboratory, food and beverage regulation, health regulation and medical devices. The administrative support will also provide legal, quality assurance, communications and information.
The full details of how this will all be achieved will be outlined in the regulations that must be approved by the National Assembly no more than 60 days after the law was published in La Gaceta as per the Political Constitution of Nicaragua.
