CASubmissionFee object
Fees for trial submission mandatory
Yes
Fees
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
Yes
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