Restructuring of the public health and pharmaceutical institutional framework
2026. November 9.In Issue No. 161 of the Hungarian Gazette, published on 29 October 2026, Government Decree No. 323/2026 (X. 29.) on the National Institute of Public Health and Government Decree No. 324/2026 (X. 29.) on the National Institute of Pharmacy were promulgated. Both Decrees will enter into force on 1 November 2026. As a result of the changes, the National Center for Public Health and Pharmacy (NNGYK) will be renamed the National Institute of Public Health (ONI), while the National Institute of Pharmacy (OGYI) will be established by way of demerger from the NNGYK and will become the legal successor of the NNGYK in respect of the functions transferred to it.
1. National Institute of Pharmacy (OGYI)
The OGYI will also operate with nationwide competence under the direction of the Ministry of Health and will be headed by a Director General. The Government designates the OGYI as the pharmaceutical state administration body and, in respect of certain statutory functions, as a healthcare state administration body.
The OGYI’s responsibilities will include, in particular:
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carrying out pharmaceutical methodological activities and scientific advisory functions supporting pharmaceutical development, as well as developing pharmaceutical and medical device methodological guidelines and professional recommendations;
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participating in tasks arising from the European Union’s cooperation on health technology assessment;
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professional cooperation with the EMA, its committees and working groups, as well as other national and international pharmaceutical, medical device and regulatory organisations, including participation in scientific consultation and scientific advisory procedures;
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performing regulatory tasks related to clinical trials of medicinal products in national and international procedures, as well as providing professional advice and developing methodological guidance in connection with clinical trials;
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performing regulatory tasks relating to medicinal products, medical devices and in vitro diagnostic medical devices, including the coordination of related authorisation, clinical, market surveillance and pharmacovigilance activities;
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performing national regulatory tasks relating to safety features to be placed on the outer packaging of medicinal products for human use;
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contributing to the development of the regulatory environment for pharmaceutical, biotechnology, medical device and digital health innovation, as well as to the development of regulatory science;
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monitoring healthcare decision-support software and artificial intelligence systems and providing professional support for their regulatory framework; and
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performing expert tasks related to the classification of medical aids and to medical technology and technological investments and operations of healthcare service providers.
As of 1 November 2026, the OGYI will take over ongoing proceedings falling within its functions and powers. The demerger will not, however, affect the calculation of procedural deadlines, the validity of procedural acts already taken or the procedural rights of the parties concerned.
2. National Institute of Public Health (ONI)
The ONI will operate with nationwide competence under the direction of the Minister responsible for healthcare and will be headed by the Chief Medical Officer.
Its main responsibilities will include:
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participation in the development and implementation of national public health programmes;
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performing professional supervisory functions over healthcare services;
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carrying out tasks related to public health, epidemiology, health promotion and occupational health;
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performing certain regulatory and professional tasks relating to food supplements, certain foods for specific groups and cosmetic products; and
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carrying out tasks relating to public health screening programmes, the Health Line (Egészségvonal) and the national telephone appointment booking centre.
The ONI will also retain the functions assigned to the Chief Medical Officer in relation to medical research involving human subjects and certain clinical trials.