National competent authorities (NCAs)

As of 31 January 2025, all EU/EEA trials will need to be conducted under Regulation (EU) 536/2014. Any EU/EEA trial with a foreseen last patient last visit after this date is required to be transitioned to the Clinical Trial Information System as soon as possible.

Sponsors of EU/EEA EudraCT trials (foreseen to be) completed/prematurely ended before 31 January 2025 need to submit an End of Trial form to the relevant NCA, or to use the available NCA tools (see below websites), in order to mark the trial accordingly.

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/

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

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

NCA Clinical trial unit e-mail: kf@dkma.dk
NCA e-mail: dkma@dkma.dk
Q&A: http://laegemiddelstyrelsen.dk/en/licensing/clinical-trials/clinical-trials-questions-and-answers

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

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

tel: + 331 5587 3000
fax:+ 331 5587 3832
website: http://ansm.sante.fr
e-mail: questions.clinicaltrials@ansm.sante.fr
Clinical trial submissions (including end of trial form): aec@ansm.sante.fr

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

Trial submissions (including end of trial form): https://cespportal.hma.eu/Account/Login?ReturnUrl=%2f

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

Trial submissions (including end of trial): https://cespportal.hma.eu/Account/Login?ReturnUrl=%2f

tel: +302132040376, +302132040355, 302132040327
e-mail: trials@eof.gr
website: http://www.eof.gr/

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

tel: 3545202100
e-mail:clinical.trials@ima.is
website: https://www.ima.is/development/clinical-trials/

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

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

clinical trials submissions (including end of trial): https://www.aifa.gov.it/en/osservatorio-nazionale-sperimentazione-clinica

State Agency of Medicines of the Republic of Latvia

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

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

Villa Louvigny
Allée Marconi
L-2120 Luxembourg
tel: +35224785593
fax:+35224795615
e-mail:clinicaltrials@ms.etat.lu
End of trial forms to be sent to: recherchebiomedicale@ms.etat.lu
website: http://www.ms.public.lu/

Parnassusplein 5
2511 VX The Hague
tel: +31703406700
NCA email (clinical trials submissions, including EoT form): bi@ccmo.nl
General email: ccmo@ccmo.nl
website: http://www.ccmo.nl

Grensesvingen 26, 0663 Oslo
tel: +47 22 89 77 00
e-mail for queries on clinical trials:klut@noma.no
e-mail for submissions:post@noma.no
website: https://www.dmp.no/godkjenning/klinisk-utproving

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
clinical trials submissions: https://www.rnec.pt/

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/

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

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