{"id":738,"date":"2026-11-09T16:52:18","date_gmt":"2026-11-09T16:52:18","guid":{"rendered":"https:\/\/kpli.hu\/?p=738"},"modified":"2026-11-09T16:52:41","modified_gmt":"2026-11-09T16:52:41","slug":"restructuring-of-the-public-health-and-pharmaceutical-institutional-framework","status":"publish","type":"post","link":"https:\/\/kpli.hu\/en\/restructuring-of-the-public-health-and-pharmaceutical-institutional-framework\/","title":{"rendered":"Restructuring of the public health and pharmaceutical institutional framework"},"content":{"rendered":"<p><span><span><span lang=\"en-GB\">In <\/span><\/span><\/span><span><span><span lang=\"en-GB\"><b>Issue No. 161 of the Hungarian Gazette, published on 29 October 2026<\/b><\/span><\/span><\/span><span><span><span lang=\"en-GB\">, Government Decree No. <\/span><\/span><\/span><span><span><span lang=\"en-GB\"><b>323\/2026 (X. 29.) on the National Institute of Public Health<\/b><\/span><\/span><\/span><span><span><span lang=\"en-GB\"> and Government Decree No. <\/span><\/span><\/span><span><span><span lang=\"en-GB\"><b>324\/2026 (X. 29.) on the National Institute of Pharmacy<\/b><\/span><\/span><\/span><span><span><span lang=\"en-GB\"> were promulgated. Both Decrees <\/span><\/span><\/span><span><span><span lang=\"en-GB\"><b>will enter into force on 1 November 2026<\/b><\/span><\/span><\/span><span><span><span lang=\"en-GB\">. As a result of the changes, the <\/span><\/span><\/span><span><span><span lang=\"en-GB\"><b>National Center for Public Health and Pharmacy (NNGYK) will be renamed the National Institute of Public Health (ONI)<\/b><\/span><\/span><\/span><span><span><span lang=\"en-GB\">, while the <\/span><\/span><\/span><span><span><span lang=\"en-GB\"><b>National Institute of Pharmacy (OGYI) will be established by way of demerger from the NNGYK<\/b><\/span><\/span><\/span><span><span><span lang=\"en-GB\"> and will become the <\/span><\/span><\/span><span><span><span lang=\"en-GB\"><b>legal successor of the NNGYK in respect of the functions transferred to it<\/b><\/span><\/span><\/span><span><span><span lang=\"en-GB\">.<\/span><\/span><\/span><\/p>\n<p><span><span><span lang=\"en-GB\"><b>1. National Institute of Pharmacy (OGYI)<\/b><\/span><\/span><\/span><\/p>\n<p><span><span><span lang=\"en-GB\">The OGYI will also operate with nationwide competence under the direction of the Ministry of Health and <\/span><\/span><\/span><span><span><span lang=\"en-GB\"><b>will be headed by a Director General<\/b><\/span><\/span><\/span><span><span><span lang=\"en-GB\">. The Government designates the OGYI as the <\/span><\/span><\/span><span><span><span lang=\"en-GB\"><b>pharmaceutical state administration body<\/b><\/span><\/span><\/span><span><span><span lang=\"en-GB\"> and, in respect of certain statutory functions, as a healthcare state administration body.<\/span><\/span><\/span><\/p>\n<p><span><span><span lang=\"en-GB\">The OGYI\u2019s responsibilities will include, in particular:<\/span><\/span><\/span><\/p>\n<ul>\n<li>\n<p><span><span><span lang=\"en-GB\">carrying out <\/span><\/span><\/span><span><span><span lang=\"en-GB\"><b>pharmaceutical methodological activities<\/b><\/span><\/span><\/span><span><span><span lang=\"en-GB\"> and <\/span><\/span><\/span><span><span><span lang=\"en-GB\"><b>scientific advisory functions supporting pharmaceutical development<\/b><\/span><\/span><\/span><span><span><span lang=\"en-GB\">, as well as developing pharmaceutical and medical device methodological guidelines and professional recommendations;<\/span><\/span><\/span><\/p>\n<\/li>\n<li>\n<p><span><span><span lang=\"en-GB\">participating in tasks arising from the <\/span><\/span><\/span><span><span><span lang=\"en-GB\"><b>European Union\u2019s cooperation on health technology assessment<\/b><\/span><\/span><\/span><span><span><span lang=\"en-GB\">;<\/span><\/span><\/span><\/p>\n<\/li>\n<li>\n<p><span><span><span lang=\"en-GB\">professional cooperation with the <\/span><\/span><\/span><span><span><span lang=\"en-GB\"><b>EMA, <\/b><\/span><\/span><\/span><span><span><span lang=\"en-GB\">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;<\/span><\/span><\/span><\/p>\n<\/li>\n<li>\n<p><span><span><span lang=\"en-GB\">performing regulatory tasks related to <\/span><\/span><\/span><span><span><span lang=\"en-GB\"><b>clinical trials of medicinal products<\/b><\/span><\/span><\/span><span><span><span lang=\"en-GB\"> in national and international procedures, as well as providing professional advice and developing methodological guidance in connection with clinical trials;<\/span><\/span><\/span><\/p>\n<\/li>\n<li>\n<p><span><span><span lang=\"en-GB\">performing regulatory tasks relating to medicinal products, <\/span><\/span><\/span><span><span><span lang=\"en-GB\"><b>medical devices and in vitro diagnostic medical devices<\/b><\/span><\/span><\/span><span><span><span lang=\"en-GB\">, including the coordination of related <\/span><\/span><\/span><span><span><span lang=\"en-GB\"><b>authorisation, clinical, market surveillance and pharmacovigilance activities<\/b><\/span><\/span><\/span><span><span><span lang=\"en-GB\">;<\/span><\/span><\/span><\/p>\n<\/li>\n<li>\n<p><span><span><span lang=\"en-GB\">performing national regulatory tasks relating to <\/span><\/span><\/span><span><span><span lang=\"en-GB\"><b>safety features to be placed on the outer packaging of medicinal products for human use<\/b><\/span><\/span><\/span><span><span><span lang=\"en-GB\">;<\/span><\/span><\/span><\/p>\n<\/li>\n<li>\n<p><span><span><span lang=\"en-GB\">contributing to the development of the <\/span><\/span><\/span><span><span><span lang=\"en-GB\"><b>regulatory environment for pharmaceutical, biotechnology, medical device and digital health innovation<\/b><\/span><\/span><\/span><span><span><span lang=\"en-GB\">, as well as to the development of regulatory science;<\/span><\/span><\/span><\/p>\n<\/li>\n<li>\n<p><span><span><span lang=\"en-GB\">monitoring healthcare <\/span><\/span><\/span><span><span><span lang=\"en-GB\"><b>decision-support software and artificial intelligence systems<\/b><\/span><\/span><\/span><span><span><span lang=\"en-GB\"> and providing professional support for their regulatory framework; and<\/span><\/span><\/span><\/p>\n<\/li>\n<li>\n<p><span><span><span lang=\"en-GB\">performing expert tasks related to the <\/span><\/span><\/span><span><span><span lang=\"en-GB\"><b>classification of medical aids<\/b><\/span><\/span><\/span><span><span><span lang=\"en-GB\"> and to medical <\/span><\/span><\/span><span><span><span lang=\"en-GB\"><b>technology and technological<\/b><\/span><\/span><\/span> <span><span><span lang=\"en-GB\"><b>investments<\/b><\/span><\/span><\/span><span><span><span lang=\"en-GB\"> and operations of healthcare service providers.<\/span><\/span><\/span><\/p>\n<\/li>\n<\/ul>\n<p><span><span><span lang=\"en-GB\"><b>As of 1 November 2026, the OGYI will take over ongoing proceedings falling within its functions and powers.<\/b><\/span><\/span><\/span><span><span><span lang=\"en-GB\"> 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.<\/span><\/span><\/span><\/p>\n<p><span><span><span lang=\"en-GB\"><b>2. National Institute of Public Health (ONI)<\/b><\/span><\/span><\/span><\/p>\n<p><span><span><span lang=\"en-GB\">The ONI will operate with nationwide competence under the direction of the Minister responsible for healthcare and <\/span><\/span><\/span><span><span><span lang=\"en-GB\"><b>will be headed by the Chief Medical Officer<\/b><\/span><\/span><\/span><span><span><span lang=\"en-GB\">.<\/span><\/span><\/span><\/p>\n<p><span><span><span lang=\"en-GB\">Its main responsibilities will include:<\/span><\/span><\/span><\/p>\n<ul>\n<li>\n<p><span><span><span lang=\"en-GB\">participation in the development and implementation of <\/span><\/span><\/span><span><span><span lang=\"en-GB\"><b>national public health programmes<\/b><\/span><\/span><\/span><span><span><span lang=\"en-GB\">;<\/span><\/span><\/span><\/p>\n<\/li>\n<li>\n<p><span><span><span lang=\"en-GB\">performing <\/span><\/span><\/span><span><span><span lang=\"en-GB\"><b>professional supervisory functions over healthcare services<\/b><\/span><\/span><\/span><span><span><span lang=\"en-GB\">;<\/span><\/span><\/span><\/p>\n<\/li>\n<li>\n<p><span><span><span lang=\"en-GB\">carrying out tasks related to <\/span><\/span><\/span><span><span><span lang=\"en-GB\"><b>public health, epidemiology, health promotion and occupational health<\/b><\/span><\/span><\/span><span><span><span lang=\"en-GB\">;<\/span><\/span><\/span><\/p>\n<\/li>\n<li>\n<p><span><span><span lang=\"en-GB\">performing certain regulatory and professional tasks relating to <\/span><\/span><\/span><span><span><span lang=\"en-GB\"><b>food supplements, certain foods for specific groups and cosmetic products<\/b><\/span><\/span><\/span><span><span><span lang=\"en-GB\">; and<\/span><\/span><\/span><\/p>\n<\/li>\n<li>\n<p><span><span><span lang=\"en-GB\">carrying out tasks relating to public health screening programmes, the Health Line (Eg\u00e9szs\u00e9gvonal) and the national telephone appointment booking centre.<\/span><\/span><\/span><\/p>\n<\/li>\n<\/ul>\n<p><span><span><span lang=\"en-GB\">The ONI will also retain the functions assigned to the Chief Medical Officer in relation to <\/span><\/span><\/span><span><span><span lang=\"en-GB\"><b>medical research involving human subjects and certain clinical trials<\/b><\/span><\/span><\/span><span><span><span lang=\"en-GB\">.<\/span><\/span><\/span><\/p>\n","protected":false},"excerpt":{"rendered":"<p>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 [&hellip;]<\/p>\n","protected":false},"author":1,"featured_media":0,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"footnotes":""},"categories":[3],"tags":[],"class_list":["post-738","post","type-post","status-publish","format-standard","hentry","category-news"],"acf":[],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v28.6 - https:\/\/yoast.com\/product\/yoast-seo-wordpress\/ -->\n<title>Restructuring of the public health and pharmaceutical institutional framework - Kelemen Kinga \u00fcgyv\u00e9di iroda<\/title>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/kpli.hu\/en\/restructuring-of-the-public-health-and-pharmaceutical-institutional-framework\/\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"Restructuring of the public health and pharmaceutical institutional framework - Kelemen Kinga \u00fcgyv\u00e9di iroda\" \/>\n<meta property=\"og:description\" content=\"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. 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