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National competent authorities (NCAs)
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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.
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Country
| Department for Clinical Trials
| Contact points for information on Clinical Trials
| Logo
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Austria
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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/
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Belgium
| FAMHP
| Galileelaan - Avenue Galilée 5/03
1210 BRUXELLES
T + 32 2 528 40 00
email: ct.rd@fagg-afmps.be
website: http://www.fagg-afmps.be
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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
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Croatia
| Ministry of Health
| 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
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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/
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Denmark
| Danish Medicines Agency | 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
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Estonia
| Republic of Estonia Agency of Medicines
| email:trials@ravimiamet.ee
website: http://www.ravimiamet.ee/
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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
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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 submissions (including end of trial form): aec@ansm.sante.fr
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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/
Trial submissions (including end of trial form): https://cespportal.hma.eu/Account/Login?ReturnUrl=%2f
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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
Trial submissions (including end of trial): https://cespportal.hma.eu/Account/Login?ReturnUrl=%2f
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Greece
| National Organization for Medicines
| tel: +302132040376, +302132040355, 302132040327
e-mail: trials@eof.gr
website: http://www.eof.gr/
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Hungary
| The National Institute of Pharmacy & Nutrition
| tel: +361 8869 311
fax:+361 8869 471
email:klinvizsg@nngyk.gov.hu
website: http://www.ogyei.gov.hu
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Iceland
| Icelandic Medicines Agency
| tel: 3545202100
e-mail:clinical.trials@ima.is
website: https://www.ima.is/development/clinical-trials/
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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
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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/
clinical trials submissions (including end of trial): https://www.aifa.gov.it/en/osservatorio-nazionale-sperimentazione-clinica
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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
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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
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Lithuania
| The State Medicines Control Agency
| Žirmūnų str. 139A,LT-09120
Vilnius, Lithuania
tel: +370 67313235
fax:+370 52639265
e-mail: ClinicalTrials@vvkt.lt
website: http://www.vvkt.lt/
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Luxembourg
| Ministère de la Santé
| 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/
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Malta
| Medicines Authority
| Sir Temi Żammit Buildings, Malta Life Sciences Park, San Ġwann, SĠN 3000, Malta
website: http://www.medicinesauthority.gov.mt
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Netherlands
| CCMO
| 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
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Norway
| Norwegian medicines Agency
| 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
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Poland
| The Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
| Address for submissions (including end of trial notifications): Al. Jerozolimskie 181C
02-222 Warszawa
tel.: + 48 22 492 11 00
fax: + 48 22 492 11 09
e-mail: urpl@urpl.gov.pl
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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
clinical trials submissions: https://www.rnec.pt/
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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/
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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/
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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/
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Spain
| AEMPS
| tel: +34 902 101322/+34 91 822 59 97
fax:+34 918 225076
e-mail: aecaem@aemps.es
website: EMC website, for submissions, including end of trial form: https://ecm.aemps.es/ecm/informacionGeneral.do |
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Sweden
| Medical Products Agency
| tel:+ 461 8174600
fax:+461 8548566
e-mail: registrator@lakemedelsverket.se
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