Procedure for Submitting of Clinical Trial Application
Summary in English
Slovak republic has adopted Commission directives 2001/20/EC and 2005/28/EC into Act No. 140/1998 Col. There are not major differences in the procedures between Slovak Acts and these directives.
Fees should be paid before submission of application.
From 1st January 2009 should be paid in Euro
Clinical trial of medicinal product for human use 331,50 €
Clinical trial with medical device 165,50 €
The bank account (payment from foreign countries):
• IBAN: SK3481800000007000133673 • BANK: Všeobecná úverová banka, a. s.
• SWIFT (BIC): SUBASKBX Mlynské Nivy 1
829 90 BratislavaThe bank account (domestic payment):
7000133673/8180
Constant symbol: 0558
Variable symbol: application number (SIDC reference number)
Variable code: EudraCT Number without hyphens and dashes.
There are no exemptions for academic research.
Request for a clinical trial authorisation should contain at least:
1. Covering Letter
Especially identification of the applicant and sponsor and list of submitted documents should be included in covering letter. As administrative procedure should be in official language covering letter should be in Slovak language.
1.1. Extract from business register (commercial person) or copy of licence (Physical person).
1.2. If the applicant is not the sponsor, a letter of authorisation enabling the applicant to act on behalf of the sponsor.
2. Application form
Printed and signed application form accessed via internet at address www.euadract.emea.eu.int. with data relevant for Slovak republic. All addresses should be correct and in Slovak language.
2.1. Receipt of confirmation of EUDRACT number
2.1. Copy of XML file of Application form
3. Investigators Brochure
4. Protocol
4.1. All actual amendments
4.2. List of relevant pharmacies in the case when clinical site does not have hospital pharmacy.
5. Subject information leaflet (in Slovak).
6. Informed consent form (in Slovak).
7. Investigational Medicinal Product Dossier (IMPD)
Full IMPD
Or Simplified IMPD
Or Summary of product characteristics
8. Declaration of GMP, GLP and GCP status of the medicinal products, preclinical and clinical data used in the clinical trial or submitted with application.
9. Applicable authorisations to cover trials or products with special characteristics e.g. GMOs, radiopharmaceuticals. (Ministry of the Environment of the Slovak republic).
10. Copy of ethics committee opinion in the MS concerned
11. Provision for indemnity or compensation in the event of injury or death.
