Essentials of European Medical Device Regulatory Affairs - June 2020

TOPRA

USEFUL WEB ADDRESSES FOR REGULATORY AFFAIRS PROFESSIONALS

The list below provides a number of useful websites for regulatory affairs professionals. The

list is not meant to be exhaustive, but will hopefully provide initial assistance. Also please

refer to the TOPRA useful links that can be found at the following address:

http://www.topra.org/information-resources/useful-links

European Regulatory Bodies

Austria

AGES - Österreichische Agentur für Gesundheit und Ernährungssicherheit (Austrian Federal Office for Health and Food Safety) AGES Medizinmarktaufsicht - Austrian Medicines and Medical Devices Agency Federale Overheidsdienst/Service Public Fédéral (Federal Public Service)

www.ages.at

http://www.basg.at/

Belgium

http://www.health.belgium.be/eportal

www.fagg-afmps.be/en

Federaal Agentschap voor Geneesmiddelen en

Gezondheidsproducten /Agence Fédérale des Médicaments et des Produits de Santé (Federal Agency for Medicines and Health Products)

Bulgaria

Bulgarian Drug Agency Ministry of Health

www.bda.bg

Croatia

HALMED - Agencija za lijekove i medicinske proizvode (Agency for Medicinal Products and Medical Devices)

www.almp.hr

Cyprus

Ministry of Health of the Republic of Cyprus Pharmaceutical Services

www.moh.gov.cy

Czech Republic

SUKL -Státní ústav pro kontrolu léčiv (State Institute for Drug Control)

www.sukl.cz (Human)

USKVBL-Ústav pro státní kontrolu veterinárních biopreparátů a léčiv (Institute for the

www.uskvbl.cz (Veterinary)

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September 2013