Pharmaceuticals and Healthcare Group
Kajtár Takács Hegymegi-Barakonyi Baker&McKenzie
3 March 2015
For more information:
Tel: +36 1 302 3330
Tel: + 36 1 302 3330
Significant Restructuring of
Healthcare Authorities with effect
from 1 March 2015
Cost saving and the rationalization of the operation of healthcare
authorities and agencies are the primary aims of the current
restructuring in the healthcare sector.
The public tasks and powers of the National Institute of Quality and
Organizational Development in Healthcare and Medicines
("GYEMSZI") were transferred to currently existing or newly
established authorities or agencies.
The Government established the following new authorities: the
National Institute of Pharmacy and Nutrition, the Healthcare
Registration and Training Center and the National Healthcare
The National Institute of Pharmacy and Nutrition ("OGYÉI") will
be responsible for the authorization of medicines and the licensing
of clinical trials, the manufacturing and the wholesale distribution of
medicines. The OGYÉI will issue the license of pharmacies and will
also supervise the retail distribution of medicines outside of
pharmacies. Also, the National Institute for Food and Nutrition
Science ("OÉTI") merged into the OGYÉI, therefore, the OGYÉI will
engage in tasks relative to food, food supplements and cosmetic
products, including the registration of food supplements, the
provision of scientific advice, testing and market surveillance. The
OGYÉI will also provide expert opinion on the classification of trials
and research activities on humans including advice on the
distinction between interventional and non-interventional trials as
well as clinical trials and other research on humans.
The Healthcare Registration and Training Center ("ENKK") will
be the legal successor of the Office of Health Authorization and
Administrative Procedure and the Human Resource Directorate of
the GYEMSZI. The ENKK will be responsible for the management of
healthcare training and the registration of healthcare professionals.
The ENKK will have various tasks and authority powers relative to
medical devices, including the licensing of clinical trials with medical
devices, market surveillance and the designation of notified bodies
responsible for conformity assessment of devices.
The ENKK will also serve as an appellate body in respect of first
instance decisions of the OGYÉI.
The National Healthcare Supply Center ("ÁEEK") will take over
the remaining powers and tasks from the GYEMSZI, including
certain management powers over state-owned healthcare
institutions and the organization of centralized public procurements
of medicinal products and medical devices for the supply of
Kajtár Takács Hegymegi-Barakonyi
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Tel: +36 1 302 3330
Fax: +36 1 302 3331
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