On this day, through the publication in LA GACETA D.O. N58 of March 24, 2021, Law No. 1068, Law Creating the National Health Regulation Authority, enters into force.
Link of the law: https://www.lagaceta.gob.ni/2021/03/058/
Summary of the Law:
Creation.
The SRNA is created as a public entity with legal personality, its own patrimony, with technical, and administrative autonomy, attached to the Ministry of Health.
Purpose.
The SRNA will have the purpose of facilitating, regulating, implementing, and coordinating policies, laws, regulations and norms related to sanitary authorizations, surveillance, promotion, publicity, control and inspection of medicines of all kinds, natural products, homeopathic, food and sold, supplements, devices and other technologies related to health. Regulation, control of donations, among others.
Competence.
The SRNA is the competent authority of the Health Ministry to execute, implement and enforce laws, its regulations, and other dispositions.
Main functions:
- Regulations, norms, and administrative elaborations and approval provisions for the regulatory framework for health management update.
- To administer and enforce, within its competence, laws No. 292, 727, 774, 156, international instruments and other laws, and regulations related to its capability.
- Coordinate the process of elaboration and approval of norms, guides, and manuals of the health sector.
- Ensure compliance with the regulatory framework of the health sector.
- Ensure compliance with the components of the quality assurance system of care.
- To regulate and supervise the organization and operation of facilities.
- To regulate and control the activities related to the use of ionizing radiation in its various fields of application.
- To evaluate, register, control the importation, donation, exportation, commercialization, storage, distribution, promotion, prescription and dispensation of medicines, cosmetics, hygienic, food and sold, devices, etc….
- Advertising regulation
- Quality and safety of food and beverages supervision.
- Management of the registry of national and foreign health professionals and technicians.
Direction and Structure:
- General Director
- Specific Management:
- Pharmacy Management
- Quality Control Laboratory Management
- Administration of Food and Beverage Regulation
- Department of Health Regulation
- Management of Medical Devices
- National Atomic Energy Commission
Supporting bodies:
Legal Advisory Section 2. - Quality management system section
- Information and Communication Technology Section
- Administrative Section
- Archive section
Rates
The rates for services rendered by the ANRS and its agencies, as mandated by this law, shall be approved, and issued through the regulations of this law.
The law application is subject to the pending regulation to be elaborated and published in the news, which will provide us with important inputs such as updated procedures and rates.
We will keep you informed of the development of this new regulatory entity in Nicaragua. For more information about this law, feel free to contact us at: nicaragua@latinalliance.co