Clinical Trials Procedures
Obsah
Slovak republic has adopted Commission directives 2001/20/EC and 2005/28/EC into Act No. 362/2011 Col. There are some differences in the procedures between Slovak Acts and these directives.
Fees should be paid before submission of application:
Clinical trial of medicinal product for human use: 331,50 €
The bank account (payment from foreign countries):
BENEFICIARY´s ACCOUNT No. (IBAN):
SK3481800000007000133673
BANK:
Všeobecná úverová banka, a. s.
Mlynské Nivy 1
829 90 Bratislava
Slovak Republic
SWIFT (BIC): SUBASKBX
BENEFICIARY:
Štátny ústav pre kontrolu liečiv
Kvetná 11
825 08 Bratislava
Slovak Republic
REMITANCE INFORMATION
(EudraCT Number without hyphens and dashes)
The bank account (domestic payment):
BENEFICIARY´s ACCOUNT No.
7000133673/8180
BANK: Štátna pokladnica
Radlinského 32
810 05 Bratislava
VARIABLE SYMBOL:
EudraCT Number without hyphens and dashes.
There are no exemptions for academic research.
Request for a clinical trial authorization 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 or bilingual.
1.1. Extract from business register (commercial person) or copy of license (physical person).
1.2. If the applicant is not the sponsor, a power of attorney enabling the applicant to act on behalf of the sponsor.
2. Application form
Printed and signed application form accessed via internet at the address https://eudract.ema.europa.eu/ 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 on CD.
3. Investigator’s Brochure
4. Protocol
4.1 Including all actual amendments
4.2 List of relevant community pharmacies in the case when trial site does not have a hospital pharmacy or trial site do not have suitable conditions of IMP storing.
4.3 Statement that the trial will be conducted in compliance with the protocol, GCP and the applicable regulatory requirements.
5. Subject information leaflet (in Slovak language)
6. Informed consent form (in Slovak language)
7. Investigational Medicinal Product Dossier (IMPD)
Full IMPD with declaration of GLP
Or Simplified IMPD
Or Summary of product characteristics
8. A copy of authorisation (licence) of health care provider(s) acting as trial site(s)
9. Applicable authorisations to cover trials or products with special characteristics e. g. GMOs (Ministry of the Environment of the Slovak republic),. Radiopharmaceuticals (Public Health Authority of the Slovak Republic),
10. Copy of ethics committee opinion