EudraCT  
  Hosted on behalf of the European CommissionEU
Home
EudraCT user manual


Registering a trial and updating its information
EudraCT number, CTA & Login for posting results
CTA & results documentation
Tutorials on posting results
Training
Frequently asked questions
National competent authorities
Statistics and technical documentation
EU Clinical Trials Register
Need Help? Contact us

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
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

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
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 Medicines Agency

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 3000
fax:+ 331 5587 3832
website: http://ansm.sante.fr
e-mail:questions.clinicaltrials@ansm.sante.fr
Clinical trial submission: clinicaltrials@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 Sir Temi Żammit Buildings, Malta Life Sciences Park, San Ġwann, SĠN 3000, Malta
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: urpl@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/
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

Slovenčeva ulica 22,
1000 Ljubljana
tel: +38682000544
fax:+38682000510
e-mail: ct@jazmp.si
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

EMA