The National Institute of Pharmacy and Nutrition (OGYÉI) is appointed by the 25/2005. (II. 25.) Government Decree as a licensing authority for pharmaceutical and public administrational matters. The main activity of OGYÉI is to provide the public with safe, effective and quality medicines in accordance with the regulations. OGYÉI is the national organisation of official drug controlling tasks and it is also the methodical and research institute of Hungary.
OGYÉI examines the notifications on the quality of medicinal products and adverse drug reaction alongside to the tasks pertaining to the authorization of medicinal products and ensuring withdrawal from the market of the defective batches posing a threat to human health. Additionally it is also OGYÉI’s task to authorize the manufacture, distribution of medicinal products and the activity of parallel import according to strict considerations and to continuously control good manufacturing-. distribution-, clinical- as well as laboratory practice concerning the development of medicinal products, and also the pharmacovigilance related activity of the marketing authorization holders. The obligation of authorizing and supervising clinical trials on investigational medicinal products, off-label indication, individual demand for medicinal product and dispensing of medicinal products are also under the competence of OGYÉI. Activities relating to gene technology and establishments carrying out such experiments in the field of human medical sector are authorized by OGYÉI, as well.
OGYÉI participates in a great number of proceedings running beyond its delegated competences as a competent authority, e.g..: the authorization of clinical trials on medical devices containing medicinal product, the enforcement of standards on advertisements and activity on medicines information.
OGYÉI advocates that fighting against counterfeit and illegal distribution of medicinal products is an overwhelmingly important task. Accordingly, OGYÉI actively participates in international co-operation against counterfeit medicinal products. The OMCL – the network of national laboratories examining medicinal products – operates under the auspieces of the European Directorate for the Quality of medicines and Healthcare (EDQM) where suspicious medicinal products are examined.
OGYÉI is also responsible for the notification of food supplements, foods for particular nutritional uses (infant formulae, complementary foods, gluten free foods, etc.), cosmetics and biocides used in food industry and mass catering. Beside that, the Institute focus on public health in relation to human nutrition, food technology, nutritional environment and hygiene. The Institute regularly monitors food consumption patterns and provide analytical services based on accredited and standardised analysis methods. Moreover, OGYÉI elaborates and updates dietary guidelines, organizes public health projects and takes part in the decision making process of food and nutrition policies both at national and international levels.
OGYÉI performs administrative tasks related of medicines supply, the Chief Pharmacist Officers supervise and coordinate the operation of pharmacies ensuring an accurate supply of appropriate products.
prepares supportive materials for decision makers on all level in health care,
prepares national and international publications, posters and presentations,
conducts health economic research, initiates legislative changes in the field
of health technology.
In order to operate even more efficiently, OGYÉI co-operates with its supervisory authority; the Ministry of Health, particularly with its Department for Pharmaceuticals and Medical Devices, with its clients and partners (National Centre for Epidemiology, National Public Health and Medical Officer’s Service, customs authorities, the Police, professional organisations, Hungarian Society for Pharmaceutical Sciences, Pharmaceutical Chamber, professional colleges).
Laboratory activity is an outstandingly professional aspect of OGYÉI which covers the supervision of marketed medicinal products, the examination of quality issues of medicinal products, the performance of necessary tests for the purpose of forensic expert’s opinions, experiments conducted within the frames of Pharmacopeia co-operation and international examinations certifying proficiency. Acknowledging the professional activity of OGYÉI, the Institution has exclusive competence as a forensic expert issuing forensic expert’s opinion regarding scientific questions on medicinal products.
Above all OGYÉI edits, revises and actualizes the Pharmacopeia Hungarica, the Formulae Normales as the collection of regulations standard and the periodic, named ‘Our Medicines’ – which is the news bulletin of OGYÉI. Beyond its official and evaluating activity, OGYÉI operates as a methodological centre, regularly organizes further training for professionals, carries out duties of methodology direction and qualifies required electronic systems for retail trade of medicinal products.
OGYÉI’s divergent professional and legal experience manifests not only in operating the law but also in its participation in preparing domestic and union-level legal acts as well as participating in the committees and working parties of the EMA and professional committees of the WHO, the Council of Europe and OECD.