ECSubmissionFee object

Fees for Ethical review mandatory

Yes

Waiver for academic (non-commercial) studies possible

No

Fees for Ethical review

Applicable fees (VAT included) from 01.01.2016:
Phase I-III: 1690 EURO
Phase IV: 768 EURO
Bioequivalence studies: 461 EURO
Amendments: 308 EURO
Non-interventional clinical trials: 310 EURO

Official guidance on required fees available

Yes

Official guidance on required fees

COMUNICAT privind tarifele CNBMDM incepand cu 01.01.2016;
(available on CNBMDM website in section "Comunicate" in Romanian only)

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