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 human medicines.

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

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

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. +43 5 0555-0
Fax +43 5 0555-22019
www.ages.at
AGES
Belgium Federal Agency for Medicines and Health Products Eurostation building, block 2
place Victor Horta, 40/ 40
1060 Brussels
Belgium
Tel. +32 2 524 7111
E-mail: info.medicines@fagg-afmps.be
www.fagg-afmps.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
Bulgarian Drug Agency / Institute for Conrol of Veterinary Medicinal Preparations
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.almp.hr
HALMED
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
Cyprus Ministry of Health - Pharmaceutical Services
Czech Republic State Institute for Drug Control Srobárova 48
100 41 Praha 10
Czech Republic
Tel. +420 272 185 333
Fax +420 272 185 756
E-mail: infs@sukl.cz
www.sukl.cz
Czeh Republic State Institute for Drug Control
Denmark Danish Medicines Agency Axel Heides Gade 1
2300 København S
Denmark
Tel. +45 7222 7400
E-mail: dkma@dkma.dk
www.laegemiddelstyrelsen.dk
Danish Medicines Agency
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
Estonian State Agency of Medicines
Finland Finnish Medicines Agency P.O. Box 55
FI-00034 FIMEA
Finland
Tel. +358 29 522 3341
Fax +358 9 4733 4339
www.fimea.fi
Finnish Medicines Agency
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
ANSM
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
Bfarm
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/
Paul Ehrlich Institut
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
National Organization for Medicines (Greece)
Hungary National Institute of Pharmacy and Nutrition Zrínyi U. 3
1051 Budapest
Hungary
Tel. +36 1 88 69 -300
Fax +36 1 88 69-460
E-mail: ogyei@ogyei.gov.hu
www.ogyei.gov.hu
National Institute of Pharmacy (Hungary)
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
Iceland national competent authority logo
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.agenziafarmaco.it
Agenzia Italiana del Farmaco
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
State Agency of Medicines (Latvia)
Liechtenstein Office of Health / Department of Pharmaceuticals Äulestr 512
9490 Vaduz
Liechtenstein
c
Office of Health/Dpt. of Pharmaceuticals (Liechtenstein)
Lithuania State Medicines Control Agency Žirmūnų g. 139A
09120 Vilnius
Lithuania
Tel. +370 5 263 9264
Tel +370 5 263 9265
E-mail: vvkt@vvkt.lt
www.vvkt.lt
State Medicines Control Agency (Lithuania)
Luxembourg Ministry of Health Allée Marconi
2120 Luxembourg
Luxembourg
E-mail: ministere-sante@ms.etat.lu
www.ms.etat.lu
Direction de la Santé Villa Louvigny Division de la Pharmacie et des Medicaments
Malta Medicines Authority 203 Rue D´Argens
GZR 03 Gzira
Malta
Tel. +356 23439000
Fax +356 23439161
E-mail: info.medicinesauthority@gov.mt
www.medicinesauthority.gov.mt
Medicines Authority Divizjoni Tas-Sahha Bezzjoni Ghar-Regolazzjoni Tal-Medicini
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
College ter Beoordeling van Geneesmiddelen Medicines Evaluation Board
Netherlands Healthcare Inspectorate Stadsplateau 1
3521 AZ Utrecht
The Netherlands
Tel. +31 88 120 5000
Fax +31 88 120 5001
E-mail: meldpunt@igz.nl
www.igz.nl
Dutch Health Inspectorate
Norway Norwegian Medicines Agency Postboks 240 Skøyen
0213 Oslo
Norway
Tel. +47 22 89 77 00
E-mail:post@noma.no
https://legemiddelverket.no
Norwegian medicines agency
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
Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
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
Main Pharmaceutical Inspectorate (Poland)
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
INFARMED
Romania National Medicines Agency 48, Av. Sanatescu
011478 Bucharest
Romania
Tel. +4021 317 11 00
Fax +4021 316 34 97
www.anm.ro
National Medicines Agency (Romania)
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
State Institute for Drug Control (Slovakia)
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
Agencija za zdravila in medicinske pripmocke
Spain Spanish Agency for Medicines and Health Products Parque Empresarial
Las Mercedes Edificio 8C/.
Campezo, 1
28022 Madrid
Spain
www.aemps.gob.es
Agencia Española de Medicamentos y Productos Sanitarios
Sweden 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
Medical Products Agency (Sweden)
United Kingdom Medicines and Healthcare Products Regulatory Agency 151 Buckingham Palace Road
Victoria
London
SW1W 9SZ
United Kingdom
Tel. +44 (0)20 3080 6000
E-mail: info@mhra.gov.uk
www.mhra.gov.uk
Medicines and Healthcare products Regulatory Agency

 

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