From November 1, Hungary will restore two separate national authorities to carry out public health and pharmaceutical regulatory tasks. The change was enacted by two government decrees published Thursday evening in the Magyar Közlöny, which establish the Országos Népegészségügyi Intézet (ONI) and the Országos Gyógyszerészeti Intézet (OGYI).
Both bodies will operate as central, nationwide offices under the authority of the Minister responsible for health, Hegedűs Zsolt.
Responsibilities of the Országos Népegészségügyi Intézet (ONI)
The ONI will be responsible for epidemic preparedness and response, public health inspections, health promotion, organizing population health screening programs, and occupational health tasks. The institute will operate national reference laboratories for epidemiology and microbiology, manage national vaccine procurement and distribution, and coordinate the work of health promotion offices.
The ONI will also run the national health hotline, including the 1812 telephone service that provides health information and booking for specialist appointments. The institute will be led by the országos tisztifőorvos (chief medical officer).
Responsibilities of the Országos Gyógyszerészeti Intézet (OGYI)
The OGYI will carry out pharmaceutical regulatory duties, including the authorization of medicines and clinical drug trials, pharmacovigilance, and oversight of pharmacies and medicine supply. Its remit will also cover market surveillance of medical devices and diagnostic equipment, and professional support for health technologies and drug development.
The decree explicitly requires the OGYI to monitor the development and operation of artificial intelligence systems used in healthcare and to prepare professional proposals for their regulation. The OGYI will be headed by a főigazgató (director general).
Background and practical effects
The re-separation effectively reverses a 2023 institutional merger. On August 1, 2023, the Orbán government combined the Nemzeti Népegészségügyi Központ (NNK) and the Országos Gyógyszerészeti és Élelmezés-egészségügyi Intézet (OGYÉI) into the Nemzeti Népegészségügyi és Gyógyszerészeti Központ (NNGYK). At the time, state secretary Takács Péter said the merger would create a simpler, more transparent authority structure and speed up approval procedures.
Under the new decrees, the NNGYK’s name will change to Országos Népegészségügyi Intézet, while the Országos Gyógyszerészeti Intézet will be established as a separate entity. The OGYI will be the legal successor to the NNGYK with respect to the tasks transferred to it and will assume the associated rights, obligations, assets and employees.
The decrees state that the reorganisation will not affect deadlines in ongoing administrative proceedings nor the rights of clients.
In the explanatory notes released with the draft decrees for public consultation on October 8, the government said the aim is to clearly separate public health and pharmaceutical functions and the personnel, asset, budgetary and IT resources needed to perform them, thereby ensuring continuity and efficiency of state service provision and uninterrupted operation of regulatory procedures.
Entry into force
The government decrees enter into force on November 1, 2026.
