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Strategic Planning for Product Development
International Regulatory Desk Research
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Technical Support in Litigation
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Publishing and Submissions Management
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Tel: +44(0)1628 530554
Fax:
+44(0)1628 530559

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With many years involvement in Regulatory Affairs, Wainwright Associates Limited has excellent experience of dealing with the EMEA and national agencies at all levels.  

While much is being done to harmonise regulations across the European Union in particular, there is still a need to fully understand the requirements of individual countries.

For your convenience, we have listed below all the EU principal regulatory authorities with links to their websites. We will endeavour to keep this up to date and add to it on a regular basis.


Useful Websites relevant to Regulatory Affairs


Country

Authority

Website

EU

European Medicines Agency (EMEA)

www.emea.europa.eu

Austria

Bundesministerium für Geshundheit und Frauen

www.bmgfj.gv.at

Belgium

Federal Public Service Health, Food Chain Safety and Environment

www.afigp.fgov.be

Bulgaria

Bulgarian Drug Agency

www.bda.bg

Cyprus

The Registrar Drugs Council Pharmaceutical Services

www.moa.gov.cy

Czech Republic

State Institute for Drug Control

www.sukl.cz/enindex.htm

Denmark

Danish Medicines Agency

www.dkma.dk

Estonia

State Agency of Medicines

www.ravimiamet.ee

Finland

National Agency for Medicines

www.nam.fi/english/index.html

France

Agence Française de Sécurité Sanitaire des produits de Santé (AFSSAPS)

www.agmed.sante.gouv.fr

Germany

Bundesinstitut für Arznemittel und Medizinprodukte (BfArM)

http://www.bfarm.de/en/index.php

Greece

National Organisation for Medicines

http://www.eof.gr/eof_en/enhome.html

Hungary

National Institute of Pharmacy

www.ogyi.hu/

Iceland

Icelandic Medicines Control Agency (ICMA)

www.lyfjastofnun.is

Ireland

Irish Medicines Board (IMB)

www.imb.ie/

Italy

Italian Medicines Agency (AIFA)

www.agenziafarmaco.it

Latvia

State Agency of Medicines

www.vza.gov.lv/index.php?setlang=en&large=

Liechtenstein

 

www.llv.li/

Lithuania

State Medicines Control Agency (SMCA)

www.vvkt.lt/index.php?1950175871

Luxembourg

Ministère de la Santé

www.etat.lu/MS/

Malta

Medicines Regulatory Unit

www.sahha.mt

Netherlands

Medicines Evaluation Board (MEB)

www.cbg-meb.nl/

Norway

Norwegian Medicines Agency

www.legemiddelverket.no/eng/default.htm

Poland

Office for Medicinal Products, Medical Devices and Biocides

www.bip.urpl.gov.pl/

Portugal

Instituto Nacional de Pharmacia e do Medicamento (INFARMED)

www.infarmed.pt/en/index.html

Romania

National Medicines Agency

www.anm.ro/en/home.html

Slovak Republic

State Institute for Drug Control

www.sukl.sk/

Slovenia

Ministrstvo za zdravje Republike Slovenije

http://www.mju.gov.si

Spain

Agencia Española de Medicamentos y productos Sanitarios

www.agemed.es/

Sweden

Medicinal Products Agency (MPA)

www.lakemedelsverket.se

United Kingdom

Medicines and Healthcare Products Regulatory Agency (MHRA)

www.mhra.gov.uk