Országos Gyógyszerészeti és Élelmezés-egészségügyi Intézet

What Országos Gyógyszerészeti és Élelmezés-egészségügyi Intézet does

Országos Gyógyszerészeti és Élelmezés-egészségügyi Intézet (OGYÉI), now operating under the Nemzeti Népegészségügyi és Gyógyszerészeti Központ (NNGYK) brand following its 2024 merger with the Nemzeti Népegészségügyi Központ (NNK), is Hungary's central regulatory authority for pharmaceuticals, food supplements, cosmetics, medical devices, biocidal products, nutrition science, and narcotic substances. Wholly owned by the Hungarian state under the Ministry of Human Capacities (EMMI/EM), the institution is headquartered in Budapest and operates as a statutory administrative body with exclusive legal authority to issue marketing authorizations, manufacturing and wholesale licenses, narcotics permits, clinical trial approvals, and medical device conformity assessments. It maintains the official Gyógyszer-adatbázis (Drug Database), the Étrend-kiegészítők nyilvántartása (Dietary Supplement Registry covering 2004-2026), and a constellation of other regulatory lists including authorized manufacturers, wholesalers, clinical trials, and restricted medical devices.

The institution's core technology consists of government regulatory IT systems including notification databases, market surveillance platforms, GLP (Good Laboratory Practice) compliance monitoring tools, medical device conformity assessment workflows, and the pharmacovigilance Mellékhatás-bejelentő (Adverse Event Reporting System). It also operates specialized portals such as the NNGYK Rendezvénybejelentő (mandatory pharmaceutical industry event reporting platform under Gyftv. 14/A), the Merőkanál.hu public nutrition education portal, and the mellekhatas.ogyei.gov.hu pharmacovigilance reporting platform. Designated conformity assessment bodies (e.g., NEOEMKI Kft., CE Certiso Kft.) operate under its authority for medical device certification.

Revenue is generated through statutory administrative service fees collected for licensing, registration, and notification activities (set by law under Gytv. 25/B § and the 50/1996 NM regulation), with a 50% discount available for SME pharmaceutical manufacturers. As a state entity, the institution is funded primarily through the Hungarian state budget. Customer segments include domestic and foreign pharmaceutical manufacturers, wholesalers, pharmacies, food supplement and cosmetic manufacturers, medical device companies, and the general Hungarian public accessing public health information through programs such as the HAPPY-Hét national school water consumption initiative. The agency maintains partnerships with WHO, EMA, the European Commission, NÉBIH, and Hungarian county government offices for inter-agency cooperation and EU regulatory alignment.

Name

Országos Gyógyszerészeti és Élelmezés-egészségügyi Intézet

Legal name

Országos Gyógyszerészeti és Élelmezés-egészségügyi Intézet

Website

https://ogyei.gov.hu

Company type

Private

Operating status

Operating

Headcount range

11–50 employees

Short description

OGYÉI (National Institute of Pharmacy and Nutrition), now part of Hungary's NNGYK, is the Hungarian state regulatory authority overseeing pharmaceuticals, food supplements, medical devices, cosmetics, and narcotics, licensing manufacturers and maintaining official drug and supplement registries.

Ownership category

akta.pro rank

Product category

Pharmaceutical Regulatory Authority

NAICS

Regulation, Licensing, and Inspection of Miscellaneous Commercial Sectors (92615)

akta.pro primary industry

Regulatory Affairs, Labeling & Advertising/Promotion Compliance (HLAJADAI)

akta.pro secondary industries

Manufacturing Quality, GMP Inspections & Compliance (HLAJADAG), Medical Device Regulators (HLAJADAC), Controlled Substances & Narcotics Regulators (HLAJADAK), Clinical Trials Authorization & Oversight (GCP) (HLAJADAF), Food Industry Licensing, Registration & Compliance Audits (HLAJAEAG)

Keywords

• Pharmaceutical regulation
• Drug licensing
• Medical device oversight
• Food supplement registry
• Public health authority

Headquarters

HQ city

Budapest

HQ country

Hungary

HQ region

Europe

Offices1 record

Markets served

GTM type

B2B

Offering type

Services

Cost components

Personnel, Operations, Technology or R&D, Infrastructure

Revenue model

1. Administrative service fees (Igazgatási szolgáltatási díj): The institute collects administrative service fees for licensing, authorization, and registration activities related to narcotics, psychotropic substances, pharmaceutical manufacturing, food supplements, cosmetics, medical devices, and clinical trials. Fee schedules are set by law (e.g., Gytv. 25/B §, 50/1996 NM regulation). SME discount of 50% is available for small and medium-sized pharmaceutical manufacturers.
2. Notification and registration fees: Fees collected for food supplement notifications (notifikation), medical device registrations, clinical trial applications, drug marketing authorization requests, and operational activity licenses for controlled substances.

Pricing tiers

Distribution channels3 records

Marketing channels6 records

Core offering

OGYÉI/NNGYK is Hungary's national regulatory authority for pharmaceutical products, food supplements, cosmetics, medical devices, narcotics, and biocidal products. It issues marketing authorizations, manufacturing licenses, product notifications, GLP certifications, and conducts market surveillance, drug safety monitoring, and public health education programs. The organization maintains official searchable regulatory databases on licensed drugs, notified dietary supplements, and authorized manufacturers and wholesalers.

Product overview

Országos Gyógyszerészeti és Élelmezés-egészségügyi Intézet (OGYÉI), now part of Nemzeti Népegészségügyi és Gyógyszerészeti Központ (NNGYK), operates as Hungary's central regulatory authority for pharmaceuticals, food safety, and medical devices. The organization maintains multiple regulatory databases including the Gyógyszer-adatbázis (Drug Database) for licensed pharmaceutical products, the Étrend-kiegészítők nyilvántartása for dietary supplements and special purpose foods, and the Egyéb nyilvántartások covering authorized manufacturers, wholesalers, clinical trials, and medical device restrictions. Beyond data management, OGYÉI/NNGYK provides regulatory services including Good Laboratory Practice (GLP) certification for preclinical testing facilities, medical device conformity assessment through designated organizations, and an adverse event reporting system for drug safety monitoring. The agency also conducts public health initiatives including the HAPPY-Hét water consumption promotion program for schools and maintains the Merőkanál.hu educational portal for school nutrition.

Differentiator

Problem solved

Functional benefit

Products and services

• Gyógyszer-adatbázis (Drug Database) Official searchable database of licensed pharmaceutical products in Hungary, including parallel import medicines, discontinued products, and pharmacy-dispensed medications, serving healthcare professionals, pharmacies, and regulatory affairs personnel.
• Étrend-kiegészítők és specifikus csoportoknak szánt élelmiszerek nyilvántartása (Dietary Supplement and Special Purpose Food Registry) Official registry of notified dietary supplements, infant formulas, foods for special medical purposes, and weight management products, including products banned from sale, serving manufacturers, importers, and the public.
• Egyéb nyilvántartások és listák (Other Registries and Lists) Comprehensive collection of regulatory lists including authorized drug manufacturers, licensed wholesalers, registered pharmaceutical intermediaries, clinical trial approvals, medical device restrictions, and trans-fat content monitoring data for industry and regulatory use.
• Laboratórium és preklinikai vizsgálóhelyek (Laboratory and Preclinical Testing Facilities) GLP-compliant preclinical toxicology testing facilities and laboratory services for pharmaceutical quality control, serving pharmaceutical manufacturers and researchers.
• Megfelelőségértékelő szervezetek (Conformity Assessment Organizations) Designated conformity assessment bodies for medical device certification, including NEOEMKI Kft. and CE Certiso Kft., providing CE marking and conformity assessment services for medical device manufacturers.
• Mellékhatás-bejelentő rendszer (Adverse Event Reporting System) Online system for healthcare professionals and patients to report adverse drug reactions, supporting drug safety monitoring and pharmacovigilance activities in Hungary.
• Merőkanál.hu - Közétkeztetési portál (Merőkanál.hu - Public Catering Portal) Educational website for parents, educators, and catering companies about school nutrition and healthy eating, part of preventive nutrition programs operated by OGYÉI/NNGYK.
• HAPPY-Hét program (HAPPY-Week Program) Annual national kindergarten and school program promoting water consumption among children as an obesity prevention initiative, targeting educational institutions across Hungary.
• GLP Nemzeti Program (GLP National Program) Good Laboratory Practice monitoring and certification program for preclinical testing facilities, including enrollment procedures for testing facilities into the Hungarian GLP National Program.

Quantifiable outcome

• Maintains registry of thousands of notified dietary supplements (2004-2026)
• +2 more outcomes

Segments4 records

Ideal customer profiles3 records

Technology focussed No

API detail

Has API

No

API docs

API detail

Core technology

AI maturity

App detail

Feature4 records

Partnerships

Seven partnerships are on record, tiered minor and core.

• WHO (World Health Organization)minorOthersNNGYK displays the WHO logo on its website indicating collaboration and alignment with WHO standards and guidelines in pharmaceutical and nutritional regulation. The institute follows WHO recommendations in public health matters.
• European Commission / EMA (European Medicines Agency)coreOthersAs an EU member state authority, NNGYK implements EU pharmaceutical directives (2002/46/EK on food supplements, 2001/83/EC on medicinal products, MDR 2017/745 on medical devices). The institute participates in EU-level regulatory processes and aligns with EMA guidelines.
• NÉBIH (Nemzeti Élelmiszerlánc-biztonsági Hivatal)coreOthersNÉBIH conducts trans fatty acid surveillance testing and reports results quarterly to NNGYK. This inter-agency data-sharing supports nutrition monitoring and public health policy in Hungary.
• Fővárosi és megyei kormányhivatalok élelmiszerlánc-biztonsági és állategészségügyi igazgatóságaicoreOthersCounty-level government offices conduct trans fatty acid surveillance testing on food products under NÉBIH coordination, with results shared with NNGYK's nutrition division.
• MAVÍZ (Magyar Víziközmű Szolgáltatók)minorGTM or Marketing PartnerMAVÍZ assists in distributing HAPPY-Hét promotional posters and infographs to registered school districts across Hungary, supporting the national water consumption promotion program for children.
• MDOSZ (Magyar Dietetikusok Országos Szövetsége)minorStrategic or Co-development PartnerMDOSZ conducted child health surveys (GYERE program) in Dunaharaszti and Szerencs that informed the HAPPY-Hét program design, providing epidemiological data on childhood obesity rates (25% of 6-12 year olds overweight/obese).
• MUS-E MagyarországminorGTM or Marketing PartnerMUS-E Hungary provided arts workshops for kindergarten children as prizes in the HAPPY-Hét program, contributing to the educational and creative aspects of the water consumption promotion campaign.

Scale indicators3 records

Recent moves4 records

Expansion highlights4 records

Direct peers

• MHRA (Medicines and Healthcare products Regulatory Agency): UK's national regulator for medicines, medical devices, and blood components. Direct functional peer handling the same regulatory categories as OGYÉI/NNGYK in Hungary.
• ANSM (Agence nationale de sécurité du médicament): France's national medicines agency responsible for drug safety, marketing authorization, and medical device regulation. Directly comparable in scope and statutory authority to OGYÉI/NNGYK.
• AGES (Österreichische Agentur für Gesundheit und Ernährungssicherheit): Austrian Agency for Health and Food Safety. Direct peer covering pharmaceuticals, medical devices, food safety, and nutrition — a particularly close functional match to OGYÉI's combined pharma-nutrition mandate.
• AIFA (Agenzia Italiana del Farmaco): Italy's national pharmaceutical regulatory authority. Performs marketing authorization, pricing/reimbursement, and pharmacovigilance functions comparable to OGYÉI's mandate.
• BfArM (Bundesinstitut für Arzneimittel und Medizinprodukte): Germany's federal authority for drugs and medical devices. Direct functional peer performing marketing authorization, pharmacovigilance, and medical device oversight at national level, similar in mandate to OGYÉI.

Broad incumbents

• European Medicines Agency (EMA): EU-level pharmaceutical regulator overseeing centralized drug approvals across member states including Hungary. Comparable as the supra-national counterpart that OGYÉI/NNGYK feeds into and aligns with for marketing authorizations and pharmacovigilance.
• U.S. Food and Drug Administration (FDA): U.S. national regulatory authority covering drugs, medical devices, food, and cosmetics. A globally recognized peer benchmark for the scope of regulatory functions OGYÉI performs at the national level in Hungary.

Regional players

• HALMED (Agencija za lijekove i medicinske proizvode): Croatian agency for medicinal products and medical devices. Smaller-scale regional peer in a neighboring EU country with comparable drug and medical device regulatory responsibilities.
• ŠÚKL (Státní ústav pro kontrolu léčiv): Czech Republic's State Institute for Drug Control. Regional peer with very comparable mandate covering drug marketing authorization, pharmacovigilance, and medical device oversight for a neighboring Central European EU member state.
• URPL (Urząd Rejestracji Produktów Leczniczych): Polish Office for Registration of Medicinal Products, Medical Devices and Biocidal Products. Regional Central European peer with overlapping pharmaceutical, medical device, and biocidal product regulatory authority.

Market position

Strengths4 records

Weaknesses4 records

Competitive moat3 records

Key risks6 records

Key highlights6 records

Customer concentration

• Facebookfacebook.com/happyhet
• LinkedInlinkedin.com/company/national-institute-of-pharmacy-and-nutrition

Revenue estimate

Valuation estimate

Number of profiles

Profiles1 record

Funding overview

Funding rounds

Investors

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M&A

Investments

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Frequently asked questions about Országos Gyógyszerészeti és Élelmezés-egészségügyi Intézet