Regulatory Agencies: Europe

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Acronyms used in the European Regulatory Environment
 

European Union

European Medecines Agency (EMA)
7 Westferry Circus, Canary Wharf, LondonE14 4HB, United Kingdom
Telephone switchboard:  (44-20) 74 18 84 00 http://www.ema.europa.eu/ema/index.jsp
European Commission
Rue de Genève, 1, 1140 Brussels. Belgium
http://ec.europa.eu/
 

Andorra

Ministry of Health and Welfare
http://www.salutibenestar.ad/
 

Austria

Federal Ministry For Health and Women
Radetzkystrasse 2, 1030 Wien
Tel. +43-1/711 00-0
Fax +43-1/711 00-14300
http://www.bmgf.gv.at - information in German

Belgium

Federal Public Service:  Health, Food Chain Safety, and Environment
Eurostation II, Place Victor Horta, 40 bte 10, 1060 Bruxelles
Téléphone : +32 (0)2 524.71.11 - Call Center : +32 (0)2 524.97.97
 

Bulgaria

Bulgarian Drug Agency
26, Yanko Sakazov Blvd., 1504, Sofia, Bulgaria
Tel: +359 2 943 40 46
Fax: +359 2 943 44 87
http://www.bda.bg/ Ministry of Health
5 "Sveta Nedelia" Square, Sofia 1000
Phone: (+359 2) 930-11-07; 981-18-30
Fax: (+359 2) 981-18-30
 

Croatia

Ministry of Health
Trg svetog Marka 2, 10000 Zagreb
Telefon: 01 4569 222
Telefaks: 01 6303 023
http://www.mzss.hr/
 

Cyprus

Ministry of Public Health
http://www.moh.gov.cy/moh/moh.nsf/index_en/index_en?OpenDocument
 

Czech Republic

Ministry of Health
Palackeho nam. 4 128 01 Praha 2
Tel.: +420 224 971 111,
Fax: +420 224 972 111,
http://www.mzcr.cz/


State Institute for Drug Control
Srobárova 48, 100 41 Praha 10
IÈ: 00 02 38 17
http://www.sukl.cz/
 

Denmark

Danish Medicines Agency
Axel Heides Gade 1, DK-2300 København S
tlf.: +45 44 88 95 95
fax +45 44 88 95 99
http://www.dkma.dk/
 

Estonia

State Agency of Medicines
1 Nooruse Str, 50411 Tartu
phone: +372 7 374 140
fax: +372 7 374 142
http://www.sam.ee
 

Finland

National Agency For Medicines
Mannerheimintie 103b, P.O.Box 55, FI-00301 Helsinki
Tel. +358 9 473 341
Fax. +358 9 714 469
http://www.fimea.fi/  
 

France

French Agency for the Safety of Medical Products (ANSM)
143/147, bd Anatole France - F-93285 Saint-Denis Cedex -
tel. +33 (0) 1 55 87 30 00
fax +33 (0) 1 55 87 30 20
http://ansm.sante.fr/
 

Germany

Federal Ministry of Health
Referat Öffentlichkeitsarbeit, 11055 Berlin 
Tel.: +49 18 88 441 - 0
Fax: +49 18 88 441 - 22 54
http://www.bmg.bund.de
 

Federal Institute For Drugs and Medical Devices
Bundesinstitut für Arzneimittel und Medizinprodukte
Kurt-Georg-Kiesinger-Allee 3, D-53175 Bonn
Tel.: +49 (0)228 207-30 (Zentrale)

Fax: +49 (0)228 207-5207
http://www.bfarm.de/
 

Greece

National Organization for Medicines
284 Messogion Av., GR-155 62, Athens, Greece
Tel: +30 210 6507200
Fax:+30 210 6545535
http://eof1.eof.gr/eof_en/enhome.html
 

Hungary

National Institute of Pharmacy
Address: 1051 Budapest, Zrínyi u. 3.
Mailing address: 1372 post office box 450.
Tel.: 317-14-88  Fax.: 318-11-67
http://www.ogyi.hu/
 

Iceland

Icelandic Medicines Control Agency
Eiðistorg 13-15, 170 Seltjarnarnes
Telephone: +354 520 2100
Fax: +354 561 2170
www.lyfjastofnun.is
 

Ireland

Irish Medicines Board
Kevin O'Malley House, Earlsfort Centre, Earlsfort Terrace, Dublin 2, Ireland. 
Tel: +353 1 6764971 Fax: +353 1 6767836
http://www.imb.ie/
 

Italy

Ministry of Health
Tel.:  06-59945397
        06-59945289
        06-59945320  
Fax:  06-59945328
http://www.ministerosalute.it/ - Information in Italian


Agenzia Italiana del Farmaco
Via Sierra Nevada 60 - 00144 Roma
centralino: 06 5978401
http://www.agenziafarmaco.it/ -  Information in Italian
 

Latvia

State Agency of Medicine
15 Jersikas street, Riga, LV-1003, Latvia
Phones: +371-7078424, +371-7078444
Mob.: +371-9447659
Fax: +371-7078428
 

Liechtenstein

Landesverwaltung
Städtle 49 . 9490 Vaduz
Tel. +423 / 236 61 11
http://www.llv.li/
 

Lithuania

State Medicines Control Agency
Trakø g.9/1, Vilnius, Lithuania
Phone: +370(5)263 92 64,
Fax: +370(5) 263 92 65
http://www.vvkt.lt/index.php?1950175871
 

Luxembourg

Ministry of Health
Allée Marconi / Villa Louvigny
L-2120 Luxembourg
http://www.ms.etat.lu/

Ministry of Health, Elderly and Community Care
Palazzo Castellania, 15, Merchant's Street, Valletta. Malta
telephone:   +356 23439000
fax:  +356 23439161 
http://www.medicinesauthority.gov.mt/
 

The Netherlands

Medicines Evaluation Board
Visitors address:  Kalvermarkt 53, 2511CB The Hague, The Netherlands
Correspondence address:P.O. Box 16229 2500 BE The Hague, The Netherlands
Telephone:  +31 70 356 74 00
Fax:  +31 70 356 75 15
http://www.cbg-meb.nl/
 

Netherlands Healthcare Inspectorate
Postbus 2680, 3500 GR Utrecht
Phone:  +31(0)88 - 1205000 - mon-fri 9:00 - 17:00
Fax: +31(0)88-1205001
http://www.igz.nl/
 

Norway

Norwegian Medicines Agency
Sven Oftedalsvei 8, NO-0950 OSLO, NORWAY
Telephone: (+47) 22 89 77 00
Telefax: (+47) 22 89 77 99
Email: post@noma.no
http://www.noma.no/
 

Poland

Main Pharmaceutical Inspectorate 
ul. D³uga 38/40, 00-238 Warszawa
tel: (04822) 635-45-81
fax: (04822) 831-02-44
email:  gif@gif.gov.pl 
http://www.gif.gov.pl/
 

Portugal

National Pharmacy and Medicines Institute (INFARMED)
Parque de Saúde de Lisboa - Avenida do Brasil, 53,   1749-004 Lisboa - Portugal
Telef: +351 217987100 
Fax: +351 217987316
 

Romania

National Medicines Agency
Str. Aviator Sanatescu, Nr. 48, Sector 1, Bucuresti, ROMANIA 
Phones: 4021 317.11.00
+4021 317.11.01
+4021 317.11.02
+4021 317.11.04
+4021 316.10.79
Fax:  +4021 316.34.97
http://www.anm.ro/en/home.html
 

San Marino

Ministry of Health and Social Security
Via Scialoja, 40 Cailungo 47893 (RSM)
Tel 0549-994111
email: direzione.generale@iss.sm
 

The Slovak Republic

State Institute for Drug Control
Kvetná 11, 825 08 Bratislava 26, Slovak Republic
tel.: +421-2-5070 1111
fax: +421-2-5556 4127
http://www.sukl.sk
 

Spain

Agencia Espanola De Medicamentos Y Productos Sanitarios
http://www.agemed.es
 

Sweden

Medical Products Agency
Postal address:  P.O. Box 26, SE-751 03 Uppsala, SWEDEN
Visiting address:  Uppsala Science Park, Dag Hammarskjölds väg 42, Uppsala, SWEDEN
Phone:  +46 18 174600;  Office hours 08.00-16.30
Fax:  +46 18 548566
http://www.lakemedelsverket.se
 

Switzerland

Swiss Agency for Therapeutic Products
Hallerstrasse 7, P.O. Box, CH-3000 Bern 9
P: +41 31 322 02 11
F: +41 31 322 02 12
http://www.swissmedic.ch/
 

Turkey

Ministry of Health
Address: Mithatpasa Cad. No:3 Sihhiye Ankara, Turkey
Phone:+90 (312) 585 2250 - +90 (312) 585 2255
Fax: +90 (312) 4339885
http://www.saglik.gov.tr/
 

Ukraine

Ministry of Health
P: (044) 253-24-39
F: (044) 253-69-75
State Administration on Medicinal and Medical Use Products
Hrushevsky Str. 7
Kyiv, Ukraine 01021
 

United Kingdom

Medicines And Healthcare Products Regulatory Agency
Information Centre, 10-2 Market Towers, 1 Nine Elms Lane, London, SW8 5N
Telephone: 020 7084 2000  (weekdays 0900 -1700); 020 7210 3000  (other times)
Fax: 020 7084 2353
http://www.mhra.gov.uk
MHRA's Page on How We Regulate

Last Update: 04 December 2012

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