CASubmissionFee object

Fees for trial submission mandatory



Authorization fees (including fees for EC review):
• New Clinical Trial Submission:
580.000 HUF (approx. €1890.-)
(In case of Preliminary opinion of CEC: 261.000 HUF to CEC and 319.000 HUF to CA)
• Amendments:
110.000HUF (Approx. 360€)
• Non-interventional trials:
370,000 HUF (approx. €1200.-)

Waiver for academic (non-commercial) studies possible


Official guidance on required fees

Fees are provided on OGYÉI website in section: Clinical trial submission procedure

Waiver for non-commercial trials: Applicable criteria are provided on OGYÉI website in section: Non-commercial clinical trials

Applicable national legal framework/ Reference

Schedule No. 1 to Act XCV of 2005