National competent authorities (human)

The European Medicines Agency works closely with the national competent authorities of the Member States of the European Union (EU) and the European Economic Area (EEA) responsible for medicinal products for human use.

The national competent authorities are primarily responsible for the authorisation of medicines available in the EU that do not fall under the scope of the centralised procedure. 

They may also be responsible for other activities related to medicinal products, such as authorisation of clinical trials.

They also supply thousands of European experts who serve as members of EMA's scientific committees, working parties or in assessment teams supporting their members.

A list of competent authorities of the Member States responsible for the authorisation of medicinal products for human use at national level and/or for the authorisation of clinical trials is provided below.

For more information on how EMA works together with the national competent authorities, see European medicines regulatory network.

List of national competent authorities in the EEA

Country	Name	Contact details
Austria	Austrian Agency for Health and Food Safety	Spargelfeldstraße 191 1220 Wien Austria Tel. [phone] Fax [phone] www.ages.at
Belgium	Federal Agency for Medicines and Health Products (FAMHP)	Avenue Galilée 5/03 1210 Brussels Belgium Tel. [phone] E-mail: [e-mail] www.famhp.be
Bulgaria	Bulgarian Drug Agency	8 Damyan Gruev Str. Sofia 1303 Bulgaria Tel. [phone] Fax [phone] E-mail: [e-mail] www.bda.bg
Croatia	Agency for medicinal products and medical devices of Croatia	Ksaverska cesta 4 10 000 Zagreb Tel. [phone] Fax: [phone] E-mail: [e-mail] www.halmed.hr
Cyprus	Ministry of Health - Pharmaceutical Services	Pharmaceutical Services Ministry of Health 1475 Nicosia Cyprus Tel: [phone] Fax: [phone] E-mail: [e-mail] www.moh.gov.cy/phs
Czechia	State Institute for Drug Control	Srobárova 48 100 41 Praha 10 Czechia Tel. [phone] Fax [phone] E-mail: [e-mail]  www.sukl.cz
Denmark	Danish Medicines Agency	Axel Heides Gade 1 2300 København S Denmark Tel. [phone] E-mail: [e-mail] www.laegemiddelstyrelsen.dk
Estonia	State Agency of Medicines	1 Nooruse Street 50411 Tartu Estonia Tel. [phone] Fax [phone] E-mail: [e-mail] www.ravimiamet.ee
Finland	Finnish Medicines Agency	P.O. Box 55 FI-00034 FIMEA Finland Tel. [phone] Fax [phone] www.fimea.fi
France	National Agency for the Safety of Medicine and Health Products	143-147 bd Anatole France 93285 Saint Denis cedex France Tel. [phone] www.ansm.sante.fr
Germany	Federal Institute for Drugs and Medical Devices	Kurt-Georg-Kiesinger-Allee 3 53175 Bonn Germany Tel. [phone] Fax [phone] E-mail: [e-mail] www.bfarm.de
Germany	Paul Ehrlich Institute	Paul-Ehrlich-Straße 51-59 63225 Langen Germany Tel. [phone] Fax [phone] E-mail: [e-mail] www.pei.de/
Greece	National Organization for Medicines	Messogion Avenue 284 15562 Athens Greece Tel. [phone] Fax [phone] E-mail: [e-mail] www.eof.gr
Hungary	National Centre for Public Health and Pharmacy	Albert Flórián út 2-6 1097 Budapest Hungary Tel. [phone] www.nnk.gov.hu
Iceland	Icelandic Medicines Agency	Vínlandsleið 14 113 Reykjavík Iceland Tel. [phone] Fax [phone] E-mail: [e-mail] www.ima.is
Ireland	Health Products Regulatory Authority (HPRA)	Kevin O'Malley House, Earlsfort Centre, Earlsfort Terrace, Dublin 2, Ireland Tel. [phone] Fax [phone] E-mail: [e-mail] www.hpra.ie
Italy	Italian Medicines Agency	Via del Tritone, 181 00187 Roma Italy Tel. [phone] Fax [phone] www.aifa.gov.it
Latvia	State Agency of Medicines	15 Jersikas Street 1003 Riga Latvia Tel. [phone] Fax [phone] E-mail: [e-mail] www.zva.gov.lv
Liechtenstein	Office of Health / Department of Pharmaceuticals	Äulestr 512 9490 Vaduz Liechtenstein www.llv.li
Lithuania	State Medicines Control Agency	Studentų str. 45A 08107, Vilnius Lithuania Tel. [phone] Tel [phone] E-mail: [e-mail] www.vvkt.lt
Luxembourg	Ministry of Health and Social Security	Allée Marconi 2120 Luxembourg Luxembourg E-mail: [e-mail] www.sante.lu
Malta	Malta Medicines Authority (MMA)	Sir Temi Żammit Buildings Malta Life Sciences Park San Ġwann SĠN 3000 Malta Tel. [phone] Fax [phone] E-mail: [e-mail] www.medicinesauthority.gov.mt
Netherlands	Medicines Evaluation Board	Graadt van Roggenweg 500 3531 AH Utrecht The Netherlands Tel. [phone] Fax [phone] Contact: Submit your question
Netherlands	Healthcare and Youth Care Inspectorate, Ministry of Health, Welfare and Sport	Stadsplateau 1 3521 AZ Utrecht The Netherlands Tel. [phone] Fax [phone] E-mail: [e-mail] www.igj.nl
Netherlands	Central Committee on Research Involving Human Subjects	Bezuidenhoutseweg 30 2594 AV The Hague The Netherlands Tel. [phone] E-mail: [e-mail]
Norway	Norwegian Medical Products Agency	Postboks 240 Skøyen 0213 Oslo Norway Tel. [phone] E-mail: [e-mail] www.dmp.no
Poland	Office for Registration of Medicinal Products, Medical Devices and Biocidal Products	Al. Jerozolimskie 181C 02-222 Warsaw Poland Tel. [phone] Fax [phone] www.urpl.gov.pl
Poland	Chief Pharmaceutical Inspectorate	Senatorska 12 00-082 Warsaw Poland Tel. [phone] Fax [phone] E-mail: [e-mail] www.gif.gov.pl
Portugal	National Authority of Medicines and Health Products	Parque de Saúde de Lisboa - Avenida do Brasil, 53 1749-004 Lisboa Portugal Tel. [phone] Fax [phone] E-mail: [e-mail] www.infarmed.pt
Romania	National Authority of Medicines and Medical Devices of Romania	Str. Aviator Sanatescu 48 011478 Bucharest Romania Tel. [phone] Fax [phone] www.anm.ro
Slovakia	State Institute for Drug Control	Kvetná 11 825 08 Bratislava 26 Slovakia Tel. [phone] Fax [phone] E-mail: [e-mail] www.sukl.sk
Slovenia	Agency for Medicinal Products and Medical Devices of the Republic of Slovenia	Slovenčeva ulica 22 1000 Ljubljana Slovenia Tel. + 38 6 8 2000 500 Fax + 38 6 8 2000 510 E-mail: [e-mail] www.jazmp.si
Spain	Spanish Agency Of Medicines And Medical Devices	Parque Empresarial Las Mercedes Edificio 8C/. Campezo, 1 28022 Madrid Spain www.aemps.gob.es
Sweden	Swedish Medical Products Agency	Dag Hammarskjölds väg 42 / Box 26 751 03 Uppsala Sweden Tel. [phone] Fax [phone] E-mail: [e-mail] www.lakemedelsverket.se

Information on coronavirus disease (COVID-19)

The national competent authorities publish information on coronavirus disease (COVID-19) and on COVID-19 treatments and vaccines in national languages. For a full list of these information resources, see:

• Information on COVID-19 from HMA and EEA Member States