1. The applicant should submit with the application also (article 34):
a. A copy of authorisation (licence) of health care provider(s) acting as trial site(s) (new)
b. A statement of ethics committee (former when it was available)
2. Sponsor should submit to subject’s health insurance company (article 35):
· A copy of clinical trial authorisation issued by CA (new)
· List of subjects insured in particular health insurance company (new)
o This list should be submitted before the beginning of trial
3. Reporting by sponsor –(article 43)
Ø Serious Adverse Event, (new)
Ø Serious Adverse Reaction (new)
Ø (Suspected) Unexpected Serious Adverse Reaction
Sponsor should report these events/reactions to:
Ø Competent Authority
Ø Ethics Committee
Ø Subject’s health insurance company (new)
4. Reporting by investigator –(article 44)
Ø Serious Adverse Event,
Ø Unexpected Serious Adverse Reaction (new)
The Investigator should report these events/reactions to:
Ø Sponsor
Ø Subject’s health insurance company (new)
5. Sponsor should pay off all expenses for (article 43):
a. clinical trial
b. Treatment of subject’s disease targeted by clinical trial (new)
c. Treatment of subject’s adverse reaction
d. Insurance of sponsor
e. Insurance of investigator
6. CA (SIDC) should publish on web-site –(Article 37) (new)
a. Investigator’s name
b. trial site
c. investigational medicinal product
d. start date and end date of clinical trial
e. financial valuation of (payments to) investigator
7. PASS studies – definition has been removed from act, but is involved in veterinary part of the act.
8. Non-intervention clinical trials – (article 45)
a. Definition was extended and includes a responsible person called “guarantee” (new)
b. It should be approved by health insurance companies, only if the medicinal product is registered less than 2 years (new)
c. The protocol and final report should be published on web-site of National Centre of Health Information (new)
9. New list of delicts (infringements)
a. Sponsor (article 138, 17a- 17u)
b. Investigator (article 138, 18a-18o)
c. “Guarantee” of non-intervention clinical trial (article 136)
10. There is no transitional period – (the Act is applicable to ongoing clinical trials) (article 143)
For more information and explanation please refer to Ministry of Health: office@health.gov.sk
Version: 8.11.2011
