New structure of health administration system: Instead of GYEMSZI ® OGYÉI
According to the 28/2015. (II.25) Decree of the Government on the National Institute of Pharmacy and Nutrition the pharmaceutical administrative tasks will be performed by the newly established National Institute of Pharmacy and Nutrition (OGYÉI), and in respect of certain tasks it was also appointed as state health administrative body.
From the aspects of the tasks performed by the GYEMSZI National Institute of Pharmacy General Directorate, Directorate of Device Testing and Clinical Engineering, Office of Health Technology Assessment the OGYÉI is the legal successor of the GYEMSZI, from the aspects of certain tasks performed by the National Public Health and Medical Officer Service (ÁNTSZ), the OGYÉI is the legal successor of the ÁNTSZ and the National Institute for Food and Nutrition Science (OÉTI).
The activities of the OGYÉI:
• The OGYÉI performs the pharmaceutical supervisory authority, market surveillance authority, genetic engineering health authority, as well as data collection, data analysis, data evaluation, research, expertise and professional methodological support tasks.
• On the field related to the food- and nutrition-health and cosmetics the OGYÉI performs the administrative, scientific research, education, training, evaluation specialist referral, coordination, professional methodology, professional monitoring, information, and domestic, international and national expert tasks.
• The OGYÉI performs the administrative tasks related to drug supply, the control, coordination and supervision of the operation of pharmacies and their medicines supply activities, the supervision of the county/metropolitan chief pharmacists, pharmacy officers.
• The OGYÉI performs the expert tasks in relation to the qualification of medical devices, the medical and technological investments and operation of the health care providers.
• The OGYÉI performs health technology evaluation functions; performs researches in relation to technology assessment, funding protocols on the state aid field.
Main activity in greater detail:
1. It performs the Drug Administration, and professional regulatory tasks specified by law;
2. On the field of medical genetic engineering it performs the administrative and technical official tasks specified by law;
3. It performs the market surveillance authority tasks specified by law;
4. It performs the professional tasks specified by law;
5. It performs the methodological and scientific research institute tasks related to its related areas of expertise;
6. Participates in performing the duties of the international drug licensing and control;
7. Performs health technology evaluation tasks; performs researches in relation to technology assessment, funding protocols on the state aid field;
8. It provides expert services and technical support in relation to the medical engineering, technological investments and operation of the medical engineering and technology of the health care providers;
9. Shall issue a certificate for the reception of the medical devices into the Social Security support, it participates as an expert in controlling the manufacturers of the custom made medical devices;
10. It provides the professional supervision in relation to the drug supply and highly controlled drugs, or drug precursors, within this framework, it ensures that medicinal products withdrawn should not be used further;
11. Designates the pharmacies and health institutions that have to keep in stock the medicines and immune biological preparations specified by the Minister responsible for health;
12. Monitors and assesses the diet - and nutrition-health related condition of the population;
13. Performs nutrition-health risk assessment, impact assessment and health check, and in relation to this performs methodological development activities, develops nutritional recommendations, examines the nutritional status of the population with anthropometric measurements, performs dietetic advisory tasks;
14. Participates in the development of the Hungarian national food and nutrition policy;
15. Performs the laboratory determination of the nutrition-related biochemical markers;
16. Performs the laboratory tests of the foods, meals served in mass catering, cosmetics, pharmaceuticals and medical devices;
17. Participates in the investigation of nutrition-related diseases;
18. In order to improve the health status of the population it participates in the identification of nutritional risk, epidemiological studies, in developing and implementing interventions;
19. It participates in the activities of the WHO and the EU in relation to the food- and nutrient-health and cosmetics, performing the duties arising from the obligation of the Member States;
20. It participates in spreading the knowledge in relation to drugs, food and nutrition with theoretical and practical trainings, with the organization of conferences, with the publication of publications and methodological materials;
21. Performs nutrition-health education tasks mandatory for the participants of mass catering;
22. Performs the public health risk assessment, pre-market assessment of the food supplements and foods for particular nutritional uses, examination relating to nutritional value labelling, nutrient composition and health;
23. Gives its opinion on the novel foods;
24. Prepares methodological, professional information for the territorial public health agencies for performing the uniform official controls;
25. Performs the food-health assessment of the biocide preparations used in the food industry;
26. As national authority performs the safety evaluation of the cosmetic preparations, inspection of the product information dossiers, operates the Cosmetic Toxicology Centre and the reporting system of the serious adverse reactions;
27. In relation to its specialization provides expert opinion, expert advice, and scientific support by the request of the public authorities, institutions and customers;
28. Performs conformity assessment tasks;
29. In its statutory scope performs technical and statistical data collection tasks, undertakes analysis;
30. It performs additional tasks specified in other statutory or regulatory decision.
