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.
| Country | Name | Contact details | |
|---|---|---|---|
| Austria | Austrian Agency for Health and Food Safety | Spargelfeldstraße 191 1220 Wien Austria Tel. +43 5 0555-0 Fax +43 5 0555-22019 www.ages.at |  |
| Belgium | Federal Agency for Medicines and Health Products (FAMHP) | Avenue Galilée 5/03 1210 Brussels Belgium Tel. +32 2 528 40 00 E-mail: welcome@fagg-afmps.be www.famhp.be |  |
| Bulgaria | Bulgarian Drug Agency | 8 Damyan Gruev Str. Sofia 1303 Bulgaria Tel. +359 2 890 35 55 Fax +359 2 890 34 34 E-mail: bda@bda.bg www.bda.bg |  |
| Croatia | Agency for medicinal products and medical devices of Croatia | Ksaverska cesta 4 10 000 Zagreb Tel. +385 1 4884 100 Fax: +385 1 4884 110 E-mail: halmed@halmed.hr www.halmed.hr |  |
| Cyprus | Ministry of Health - Pharmaceutical Services | Pharmaceutical Services Ministry of Health 1475 Nicosia Cyprus Tel: +357 22608620 Fax: +357 22608649 E-mail: phscentral@phs.moh.gov.cy www.moh.gov.cy/phs |  |
| Czechia | State Institute for Drug Control | Srobárova 48 100 41 Praha 10 Czechia Tel. +420 272 185 333 Fax +420 272 185 756 E-mail: infs@sukl.cz www.sukl.cz |  |
| Denmark | Danish Medicines Agency | Axel Heides Gade 1 2300 København S Denmark Tel. +45 7222 7400 E-mail: dkma@dkma.dk www.laegemiddelstyrelsen.dk |  |
| Estonia | State Agency of Medicines | 1 Nooruse Street 50411 Tartu Estonia Tel. +372 737 41 40 Fax +372 737 41 42 E-mail: info@ravimiamet.ee www.ravimiamet.ee |  |
| Finland | Finnish Medicines Agency | P.O. Box 55 FI-00034 FIMEA Finland Tel. +358 29 522 3341 Fax +358 29 522 3002 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. +33 1 55 87 30 00 www.ansm.sante.fr |  |
| Germany | Federal Institute for Drugs and Medical Devices | Kurt-Georg-Kiesinger-Allee 3 53175 Bonn Germany Tel. +49 (0)228-207-30 Fax +49 (0)228-207-5207 E-mail: poststelle@bfarm.de www.bfarm.de |  |
| Germany | Paul Ehrlich Institute | Paul-Ehrlich-Straße 51-59 63225 Langen Germany Tel. +49 6103 77 0 Fax +49 6103 77 1234 E-mail: pei@pei.de www.pei.de/ |  |
| Greece | National Organization for Medicines | Messogion Avenue 284 15562 Athens Greece Tel. +30 213 2040 200 Fax +30 210 6545 535 E-mail: relation@eof.gr www.eof.gr |  |
| Hungary | National Centre for Public Health and Pharmacy | Albert Flórián út 2-6 1097 Budapest Hungary Tel. +36 1 476 1100 www.nnk.gov.hu |  |
| Iceland | Icelandic Medicines Agency | Vínlandsleið 14 113 Reykjavík Iceland Tel. +354 520 2100 Fax +354 561 2170 E-mail: ima@ima.is www.ima.is |  |
| Ireland | Health Products Regulatory Authority (HPRA) | Kevin O'Malley House, Earlsfort Centre, Earlsfort Terrace, Dublin 2, Ireland Tel. +353 1 676 4971 Fax +353 1 676 7836 E-mail: info@hpra.ie www.hpra.ie |  |
| Italy | Italian Medicines Agency | Via del Tritone, 181 00187 Roma Italy Tel. +39 06 5978401 Fax +39 06 59784312 www.aifa.gov.it |  |
| Latvia | State Agency of Medicines | 15 Jersikas Street 1003 Riga Latvia Tel. +371 7078424 Fax +371 7078428 E-mail: info@zva.gov.lv 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. +370 5 263 9264 Tel +370 5 263 9265 E-mail: vvkt@vvkt.lt www.vvkt.lt |  |
| Luxembourg | Ministry of Health | Allée Marconi 2120 Luxembourg Luxembourg E-mail: ministere-sante@ms.etat.lu www.sante.lu |  |
| Malta | Malta Medicines Authority (MMA) | Sir Temi Żammit Buildings Malta Life Sciences Park San Ġwann SĠN 3000 Malta Tel. +356 23439000 Fax +356 23439161 E-mail: info.medicinesauthority@gov.mt www.medicinesauthority.gov.mt |  |
| Netherlands | Medicines Evaluation Board | Graadt van Roggenweg 500 3531 AH Utrecht The Netherlands Tel. +31 (0) 88 224 8000 Fax +31 (0) 88 224 8001 Contact: Submit your question |  |
| Netherlands | Healthcare and Youth Care Inspectorate, Ministry of Health, Welfare and Sport | Stadsplateau 1 3521 AZ Utrecht The Netherlands Tel. +31 88 120 5000 Fax +31 88 120 5001 E-mail: meldpunt@igz.nl www.igj.nl |  |
| Netherlands | Central Committee on Research Involving Human Subjects | Bezuidenhoutseweg 30 2594 AV The Hague The Netherlands Tel. +31 (0) 70 340 6700 E-mail: ccmo@ccmo.nl |  |
| Norway | Norwegian Medical Products Agency | Postboks 240 Skøyen 0213 Oslo Norway Tel. +47 22 89 77 00 E-mail: post@dmp.no www.dmp.no |  |
| Poland | Office for Registration of Medicinal Products, Medical Devices and Biocidal Products | Al. Jerozolimskie 181C 02-222 Warsaw Poland Tel. +48 (22) 492 11 00 Fax +48 (22) 492 11 09 www.urpl.gov.pl |  |
| Poland | Chief Pharmaceutical Inspectorate | Senatorska 12 00-082 Warsaw Poland Tel. +48 22 831 21 31 Fax +48 22 831 02 44 E-mail: gif@gif.gov.pl 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. +351 217987100 Fax +351 217987316 E-mail: infarmed@infarmed.pt www.infarmed.pt |  |
| Romania | National Authority of Medicines and Medical Devices of Romania | Str. Aviator Sanatescu 48 011478 Bucharest Romania Tel. +4021 317 11 00 Fax +4021 316 34 97 www.anm.ro |  |
| Slovakia | State Institute for Drug Control | Kvetná 11 825 08 Bratislava 26 Slovakia Tel. +421 2 5070 1111 Fax +421 2 5556 4127 E-mail: sukl@sukl.sk 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: info@jazmp.si 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. +46 18 17 46 00 Fax +46 18 54 85 66 E-mail: registrator@mpa.se www.lakemedelsverket.se |  |
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: