National Competent Authorities

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In the United Kingdom the National Competent Authority is the MHRA, The Medicines Healthcare Products Regulatory Agency, but who regulates the rest of Europe?

Answers can be found on the European Medicines Agency website where there is a full list of the National Competent Authorities.

Where possible we link you to the English version of the website, but not all sites appear to have English translation options.

Austria; Austrian Agency for Health and Food Safety

Belgium; Federal Agency for Medicines and Health Products

Bulgaria; Bulgarian Drug Agency

Croatia; Agency for medicinal products and medical devices of Croatia

Cyprus; Ministry of Health – Pharmaceutical Services

Czech Republic; State Institute for Drug Control

Denmark; Danish Health and Medicines Authority

Estonia; State Agency of Medicines

Finland; Finnish Medicines Agency

France; National Agency for the Safety of Medicine and Health Products/

Germany; Federal Institute for Drugs and Medical Devices

Germany; Paul Ehrlich Institute


Hungary; National Institute of Pharmacy

Iceland; Icelandic Medicines Agency

Ireland; Healthcare Products Regulatory Authority (New Name for the Irish Medicines Board)

Italy; Italian Medicines Agency

Latvia; State Agency of Medicines

Lichtenstein; Office of Health / Department of Pharmaceuticals

Lithuania; State Medicines Control Agency

Luxembourg; Ministry of Health

Malta; Medicines Authority

Netherlands; Medicines Evaluation Board

Netherlands; Healthcare Inspectorate

Norway; Norwegian Medicines Agency

Poland; Office for Registration of Medicinal Products, Medical Devices and Biocidal Products

Portugal; National Authority of Medicines and Health Products

Romania; National Medicines Agency

Slovakia; State Institute for Drug Control

Slovenia; Agency for Medicinal Products and Medical Devices of the Republic of Slovenia

Spain; Spanish Agency for Medicines and Health Products

Sweden; Medical Products Agency

Are you compliant with EU GDP 2013/C 343/01?

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