Hungary restructures its health authority: key changes for pharmaceutical and public health businesses

Hungary has restructured its central health authority, the National Public Health and Pharmaceutical Centre (NNGYK). From 1 November 2026, the NNGYK is operating as the National Public Health Institute (ONI), while a new National Institute of Pharmacy (OGYI) has been spun off from it to regulate medicines and medical devices. Pending cases will continue without disruption, but businesses should update their regulatory contacts and filings for the future.

The Hungarian Government has adopted Government Decree 323/2026. (X. 29.) on the National Public Health Institute and Government Decree 324/2026. (X. 29.) on the National Institute of Pharmacy, which were both published on 29 October 2026. The decrees replace Government Decree 333/2023. (VII. 20.) on the NNGYK. Both bodies are central offices directed by the minister responsible for health and have nationwide competence. 

The reorganisation is the latest step in a turbulent institutional history. The NNGYK itself was created only in 2023 when the National Public Health Centre was renamed and merged with the National Institute of Pharmacy and Nutrition. The two new bodies (the ONI and OGYI) therefore largely restore the previous split between public health and pharmaceutical regulation just over three years after the merger, with some jurisdictional differences. For example, matters of nutrition now fall under public health function rather than the pharmaceutical regulation.

The ONI has been established by changing the name of the NNGYK and operates as the general legal successor of the NNGYK. The OGYI, however, has been created anew, by being spun off from the ONI (i.e. formerly the NNGYK). 

National Public Health Institute (Országos Népegészségügyi Intézet, ONI)

The ONI is headed by the national chief medical officer and retains the public health portfolio, including environmental, food, nutrition and radiation health, chemical safety, epidemiology, reference laboratories, health promotion and occupational health. The ONI procures and distributes the annual national vaccine supply and runs the Egészségvonal health information service and the national telephone appointment booking centre. ONI will also remain the national authority for cosmetic products under Regulation (EC) No 1223/2009. The ONI’s scientific advisory board keeps a list of banned and restricted plants and substances in foods and food supplements. The list is published on the ONI’s website and is binding for products placed on the market.

National Institute of Pharmacy (Országos Gyógyszerészeti Intézet, OGYI)

The OGYI is led by a director general and acts as the general pharmaceutical state administration body, taking over the NNGYK’s medicines and medical device functions and has the following main responsibilities:

• serving as the competent authority under the Medicines Thrift Act (Act XCVIII of 2006), Hungary’s primary law on the supply and promotion of medicinal products and medical aids;
• serving as the competent authority under the Clinical Trials Regulation (EU) No 536/2014 and the safety features rules of Regulation (EU) 2016/161;
• serving as the competent authority, market surveillance and designating authority functions under the MDR and the IVDR, including the designation of conformity assessment bodies;
• providing scientific advice supporting medicine development and cooperation with the European Medicines Agency; and
• monitoring healthcare AI systems and decision-support software and proposing rules for their regulation.

The OGYI is the legal successor of the NNGYK for the transferred tasks, including assets, staff, EU-funded projects and pending court proceedings. It acts in pending cases after the date of the demerger, but time limits, completed procedural steps and the procedural rights of parties are unaffected. The same safeguards apply to cases that remain with the ONI. 

Next steps

Since the new rules are already in force, businesses involved in pharmaceutical, medical device, food supplement and cosmetics should identify the body that now handles their matters, update their regulatory correspondence and filings, and check the status of pending applications, particularly clinical trials and wholesale licensing procedures.

For more information on how the reorganisation could affect your Hungary-based business, contact your CMS client partner or the local CMS experts who authored this article.

This article was co-authored by Lili Benyovszki and Hunor Bendegúz Jávorszki.