National Competent Authorities

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.

European 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 Greece; http://www.eof.gr/ 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?