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Regulatory Focus™ > News Articles > 2020 > 1 > The Essential List of Regulatory Authorities in Europe

The Essential List of Regulatory Authorities in Europe

Posted 22 January 2020 | By Michael Mezher 

The Essential List of Regulatory Authorities in Europe

To ease the process of finding drug and medical device regulators in Europe, Focus has updated its list of the website(s) for each country’s ministry of health and regulatory authority. The list is organized by regional affiliation with the European Union (EU), European Free Trade Association (EFTA) and other European countries.

For countries that do not list a regulatory authority, regulatory functions are either performed by the ministry of health, or the information available online was unclear. Additionally, some of the agencies listed do not appear to have websites, or the websites are not functioning as of this publication.

If you notice an issue with this page or wish to submit a correction please email Focus at news@raps.org.
Country Drug Regulatory Authority Medical Devices Regulatory Authority Ministry of Health
European Union (EU)
Austria Federal Office for Safety in Health Care (BASG) Federal Office for Safety in Health Care (BASG) Federal Ministry of Labour, Social Affairs, Health and Consumer Protection
Belgium Federal Agency for Medicines and Health Products (FAMHP) Federal Agency for Medicines and Health Products (FAMHP) Federal Public Service (FPS) Health, Food Chain Safety and Environment
Bulgaria Bulgarian Drug Agency (BDA) Bulgarian Drug Agency (BDA) Ministry of Health
Croatia Agency for medicinal products and medical devices of Croatia (HALMED) Agency for medicinal products and medical devices of Croatia (HALMED) Ministry of Health
Cyprus Ministry of Health – Pharmaceutical Services Ministry of Health – Medical & Public Health Services, Cyprus Medical Devices Competent Authority Ministry of Health
Czech Republic State Institute for Drug Control (SUKL) State Institute for Drug Control (SUKL) Ministry of Health of the Czech Republic
Denmark Danish Medicines Agency Danish Medicines Agency Ministry of Health
Estonia Agency of Medicines Health Board, Medical Devices Ministry of Social Affairs
Finland Finnish Medicines Agency (FIMEA) Finnish Medicines Agency (FIMEA) Ministry of Social Affairs and Health
France National Agency for Medicines and Health Products Safety (ANSM) National Agency for Medicines and Health Products Safety (ANSM) Ministry for Solidarity and Health
Germany Federal Institute for Drugs and Medical Devices (BfArM), Paul-Ehrlich-Institut (PEI) Federal Institute for Drugs and Medical Devices (BfArM) Federal Ministry of Health
Greece National Organization for Medicines National Organization for Medicines Ministry of Health
Hungary National Institute of Pharmacy and Nutrition Department for Medical Devices, National Institute of Pharmacy Ministry of Human Capacities
Ireland Health Products Regulatory Authority (HPRA) Health Products Regulatory Authority (HPRA) Department of Health
Italy Italian Medicines Agency (AIFA) Directorate-General for Medical Devices and Pharmaceutical Service Ministry of Health
Latvia State Agency of Medicines State Agency of Medicines Ministry of Health of the Republic of Latvia
Lithuania State Medicines Control Agency State Health Care Accreditation Agency Ministry of Health of the Republic of Lithuana
Luxembourg Ministry of Health Ministry of Health Ministry of Health
Malta Medicines Authority Malta Competition and Consumer Affairs Authority Ministry for Health
Netherlands Medicines Evaluation Board, Farmatec Farmatec Ministry of Health, Welfare and Sport
Poland Office for Registration of Medicinal Products, Medical Devices and Biocidal Products Office for Registration of Medicinal Products, Medical Devices and Biocidal Products Ministry of Health
Portugal Infarmed Infarmed Ministry of Health
Romania The National Agency for Medicines and Medical Devices (NAMMD) The National Agency for Medicines and Medical Devices (NAMMD) Ministry of Health
Slovakia State Institute for Drug Control (SUKL) State Institute for Drug Control (SUKL) Ministry of Health of the Slovak Republic
Slovenia Agency for Medicines and Medical Devices (JAZMP) Agency for Medicines and Medical Devices (JAZMP) Ministry of Health
Spain Spanish Agency of Medicines and Medical Products (AEMPS) Spanish Agency of Medicines and Medical Products (AEMPS) Ministry of Health, Consumer Affairs and Social Welfare
Sweden Medical Products Agency Medical Products Agency Ministry of Health and Social Affairs
United Kingdom Medicines and Healthcare products Regulatory Agency (MHRA) Medicines and Healthcare products Regulatory Agency (MHRA) Department of Health and Social Care
European Free Trade Association (EFTA)
Iceland Icelandic Medicines Agency Icelandic Medicines Agency Ministry of Health
Liechtenstein Office of Health Office of Health Office of Health
Norway Norwegian Medicines Agency Norwegian Medicines Agency Ministry of Health and Care Services
Switzerland Swissmedic Swissmedic Federal Office of Public Health (FOPH)
Other Countries
Albania     Ministry of Health
Andorra     Ministry of Health
Belarus Center for Expertise and Testing in Healthcare Center for Expertise and Testing in Healthcare Ministry of Health
Bosnia and Herzegovina The Agency for Medicinal Product and Medical Devices The Agency for Medicinal Product and Medical Devices Federal Ministry of Health
Macedonia Agency for Medicinal Products and Medical Devices Agency for Medicinal Products and Medical Devices Ministry of Health
Moldova Medicines and Medical Devices Agency Medicines and Medical Devices Agency Ministry of Health, Labour and Social Protection
Montenegro Agency for Medicines and Medical Devices of Montenegro Agency for Medicines and Medical Devices of Montenegro Ministry of Health
San Marino     Ministry of Health and Social Security
Serbia Medicines and Medical Devices Agency of Serbia Medicines and Medical Devices Agency of Serbia Ministry of Health
Ukraine State Service of Ukraine on Medicines and Drug Control State Service of Ukraine on Medicines and Drug Control Ministry of Health

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