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National Competent Authorities (NCAs)

Country Department for Clinical Trials, Institute Surveillance Information on Clinical Trials
Austria


BASG - Austrian Federal Office for Safety
in Health Care


AGES - Austrian Medicines & Medical
Devices Agency

Traisengasse 5
1200 Vienna
Austria
tel: 0043 (0)50555 36827
e-mail:clinicaltrials@ages.at
website: http://www.basg.gv.at/en/medicines
/
prior-to-authorisation/clinical-trials/

Belgium FAMHP EUROSTATION 2
place Victor Horta, 40/ 40
B - 1060 BRUSSELS
email: welcome@fagg-afmps.be
website: http://www.fagg-afmps.be
Republic of Bulgaria Bulgarian Drug Agency

8, Damyan Gruev Str.
1303, Sofia, Bulgaria
tel: + 359 2 8903555
fax:+ 359 2 8903434
e-mail: bda@bda.bg
website: http://www.bda.bg/
Department Clinical Trials
tel: + 359 2 8903491

Czech Republic State Institute for Drug Control Šrobárova 48
100 41 Praha 10
tel: + 00 420272185817
fax: + 00 420272185816
e-mail: posta@sukl.cz
website: http://www.sukl.cz/
Denmark Danish Health and Medicines Authority

Web site: www.dhma.dk
NCA e-mail: dkma@dkma.dk
FAQ (Q+A): http://laegemiddelstyrelsen.dk/en/licensing/clinical-trials/clinical-trials-questions-and-answers
NCA Clinical trial unit e-mail: kf@dkma.dk

Estonia Republic of Estonia Agency of Medicines

email:info@ravimiamet.ee
website: http://www.ravimiamet.ee/

Finland Finnish Medicines Agency FIMEA

P.O.Box 55, 
FI-00034 FIMEA, Finland
tel: +358 29 522 3341
fax:+358 29 522 3002
e-mail:clinicaltrials@fimea.fi
website:http://www.fimea.fi

 
France Agence Nationale de Sécurité du Médicament et des Produits de Santé tel: + 331 5587 3655
fax:+ 331 5587 3832
website: http://ansm.sante.fr
Germany (BfArM) Federal Institute for Drugs and medical Devices

tel: +49 0 228 207 4318
fax:+49 0 228 207 4355
email:ct@bfarm.de
website:http://www.bfarm.de/

Germany (PEI)

Paul-Ehrlich Institut

Clinical Trial Section
Paul-Ehrlich Str. 55-59
63225 Langen
Germany
tel: +49 (0)6103 771810
fax:+49 (0) 6103 771277
e-mail:ct@pei.de
website:http://www.pei.de/EN/information/license-applicants/clinical-trial-authorisation/clinical-trial-authorisation-node.html

Greece National Organization for Medicines

tel: +302132040376, +302132040377, 302132040327
fax:+302132040327
e-mail: trials@eof.gr
website: http://www.eof.gr/

Hungary The National Institute of Pharmacy & Nutrition

tel: +361 8869 311
fax:+361 8869 471
email:klinvizsg@ogyei.gov.hu
website: http://www.ogyei.gov.hu

Iceland Icelandic Medicines Agency

tel: 3545202100
fax:3545612170
e-mail:ima@ima.is
website: http://www.ima.is/licences/clinical_trials/

Ireland Health products Regulatory Authority (HPRA)

Kevin O'Malley House
Earlsfort Centre
Earlsfort Terrace
Dublin 2, Ireland
tel: +353 1 6764971
fax:+353 1 6767836
email: clinicaltrials@hpra.ie
website: http://www.hpra.ie

Italy Italian Medicines Agency

tel: +390 659 784357
fax:+390 659 784720
e-mail: sperimentazione.clinica@aifa.gov.it
website: http://www.agenziafarmaco.gov.it/

Latvia

State Agency of Medicines of the Republic of Latvia

Jersikas street 15, Riga, LV-1003, Latvia
tel: +371 67078433
fax:+371 67078428
e-mail: CT@zva.gov.lv
website: http://www.zva.gov.lv                              
Latvia
Liechtenstein Amt für Gesundheit

Äulestrasse 51
9490 Vaduz
tel: + 00423 236 73 31 (secr)
fax:+ 00423 236 73 50
e-mail: pharminfo@llv.li
website:http://www.ag.llv.li

Lithuania The State Medicines Control Agency

Žirmūnų str. 139A,LT-09120
Vilnius, Lithuania
tel: +370 67313235
fax:+370 52639265
e-mail: nr.iktk@vvkt.lt
website: http://www.vvkt.lt/

Luxembourg Ministère de la Santé

Villa Louvigny
Allée Marconi
L-2120 Luxembourg
tel: +35224785593
fax:+35224795615
e-mail:luxdpm@ms.etat.lu
website:http://www.ms.public.lu/

Malta Medicines Authority 203 Level 3, Rue D'Argens
GŻR-1368 Gżira
website: http://www.medicinesauthority.gov.mt
Netherlands CCMO

Parnassusplein 5
2511 VX  The Hague
tel: +31703406700
NCA email: bi@ccmo.nl
General email: ccmo@ccmo.nl
website: http://www.ccmo.nl

Norway Norwegian medicines Agency

NO-Postboks 63,  Kalbakken, 0901 Oslo
tel: +47 22 89 77 00
e-mail for queries on clinical trials:klut@noma.no
e-mail for submission:post@noma.no
website: http://legemiddelverket.no/Godkjenning_og_regelverk/Klinisk-utproving/Sider/default.aspxhttp://legemiddelverket.no/English/Clinical_trials/
Sider/default.aspx

Poland The Office for Registration of Medicinal Products, Medical Devices and Biocidal Products Al. Jerozolimskie 181C
02-222 Warszawa
tel.: + 48 22 492 11 00
fax: + 48 22 492 11 09
e-mail: ndl@urpl.gov.pl
Portugal Infarmed

Parque de Saúde de Lisboa
Avenida do Brasil, nº53. 1749-004 Lisboa
Portugal.
tel: +351217987283
fax:+351217987248
e-mail:  ensaios.clinicos@infarmed.pt
website: Infarmed Clinical Trials page

Romania National Agency for Medicines and Medical Devices Str. Aviator Sănătescu nr. 48, sector 1
Bucureşti 011478- RO
tel: + 4 0757 117 259
fax: +4 0213 163 497
website: http://www.anm.ro/anmdm/
Republic of Croatia Ministry of Health

Ksaver 200a
10000 Zagreb
Croatia
tel: +385 1 46 07 555
fax: +385 1 46 77 076
e-mail: pitajtenas@miz.hr
website: https://zdravlje.gov.hr/
https://zdravlje.gov.hr/o-ministarstvu/djelokrug-1297/lijekovi-i-medicinski-proizvodi-1349/1349

Croatia
Slovakia

State Institute for Drug Control

Kvetná 11
825 08 Bratislava 26
Slovak Republic
tel: 004212 5070 1209
fax:004212 5070 1237
e-mail: trial-sukl@sukl.sk
website: http://www.sukl.sk/

Slovenia Agency of the Republic of Slovenia for Medicinal Products and Medical Devices

tel: +38682000539
fax:+38682000510
website:http://www.jazmp.si/

Spain AEMPS tel: +34 902 101322/+34 91 822 59 97
fax:+34 918 225076
e-mail: aecaem@aemps.es
website: https://www.aemps.gob.es/informa/info-atencion-ciudadano/home.htm#atencion_Telefonica https://www.aemps.gob.es/informa/info-atencion-ciudadano/home.htm#atencion_Telefonica
Sweden Medical Products Agency

tel:+ 461 8174600
fax:+461 8548566
e-mail: registrator@mpa.se

United Kingdom MHRA

MHRA - Clinical trials
tel:+ 44203 080 6456
e-mail:clintrialhelpline@mhra.gov.uk website:https://www.gov.uk/government/
collections/clinical-trials-for-medicines

EMA