CATrialAuthorisation object
Competent Authority/-ies (CA)
Ethics committee(s)
Interventional MD investigations
Observational MD investigations
National CA
No official national register for clinical studies or healthy volunteers is availabe.
Only devices combined with IMP need to be registered in a registry. (Not needed, if the integral part of the MD is a legally marketed medicinal product)
The application should be sent to the OGYÉI and it will be forwarded by them to the Scientific and Research Ethics Committee (ETT-TUKEB).
If the drug constituent is an IMP, opinion of NIPN/OGYÉI as a Special authority is necessary! The HRTC will call upon the NIPN/OGYÉI for its opinion.
If it is a legally marketed medicinal product, NIPN/OGYÉI approval is not required, the marketing authorization of medicinal product should be attached to the applicaton
Special authority for Ethical approval: Medical Research Council- ETT TUKEB
(NB! there is no possibility for preliminary opinion – the HRTC will call upon the TUKEB for its opinion)