The Health Inspectorate is a State direct administration authority under the authority of the Minister for Health, which implements the functions of the State administration in the supervision and control of the health sector in order to ensure compliance with the requirements of the regulatory enactments regulating the field of health, public health and pharmaceutical activity for quality and qualified health care, as well as a safe and healthy life environment.
The Health Inspectorate was established on 1 October 2007 by merging three Inspectorates - the State Sanitary Inspection, the State Pharmaceutical Inspection and the Medical Care and Health Quality Control Inspectorate (in accordance with Order No. 432 of the Cabinet of Ministers on 11.07.2007 on the Quality Control Inspectorates for Medical Care and Health Inspectorates, the State Pharmaceutical Inspectorate and the State Sanitary Inspection reorganisation of the Inspectorate and establishment of the Health Inspectorate).
1 September 2009 in accordance with 29.07.2009. Cabinet Order No. 509 On Reorganisation of State Administrative Institutions subordinate to the Ministry of Health, the Inspectorate also took over part of the functions of the Public Health Agency - Monitoring of Diseases (except Infectious Diseases), monitoring of such environmental factors that cause illness and monitoring of the implementation of health promotion in the regions.
On 1 October 2009, from the State Agency of Health Statistics and Medical Technologies, the Health Inspectorate shall take over the replenishment of the register of medical treatment institutions and updating of information, the maintenance of the register of medical practitioners, as well as the supervision of users, manufacturers and the market of medical devices. However, from the Medical Vocational Training Centre - the maintenance of the Register of Medical Aid Persons.
The Inspectorate shall also perform the possibility of receiving health care services and supervision of the provision thereof, when checking compliance with regulatory enactments and contracts, previously the competence of the State Agency of Health mandatory insurance.
The operation of the health inspection shall be determined by the 'By-law of the Health Inspectorate' (Cabinet Regulation No. 309 of 9 July 2019).
Eight lines of action have been identified for the Health Inspectorate:
- Control of medical treatment institutions;
- Monitoring of the distribution and use (operation) of medical devices;
- Monitoring of health care quality and health assessment;
- Maintenance of the register of medical treatment institutions, medical practitioners and medical treatment support persons;
- Control of pharmaceutical, veterinary pharmaceutical business and the circulation of medicinal products;
- Increased control of risk subjects;
- Monitoring of environmental factors affecting public health;
- Monitoring of chemicals and mixtures, cosmetic products, tobacco products and electronic cigarettes.