CASubmissionFee object

Fees for trial submission mandatory

Yes

Fees

Authorisation of clinical trial on MP (Type A): 67 300 CZK (2692€)
Notification of clinical trial on authorized MP (Type C): 15 800 CZK (632€)
Other notification of a clinical trial on MP: 33 900 CZK (1356€)
Substantial amendments: 15800 CZK (632€)
Academic clinical trials: exempt from fees

Waiver for academic (non-commercial) studies possible

Yes

Official guidance on required fees

SUKL guideline UST-29 or UST-24 (in Czech only) or SUKL website in English: Covering expenditures: Clinical trials etc. - status: 5.10.2013)

Additional Information

Types of IMP obtained by biotechnology or containing substances of human or animal origin:
Type A: IMP is NOT authorised in the Czech Republic or in other EU Member States.
Type B: IMP is authorised in the Czech Republic or in other EU Member States, but not used in accordance with the terms of marketing authorization
Type C: IMP is authorised in the Czech Republic and used in accordance with the terms of marketing authorisation

This project (ECRIN Integrating Activity/ECRIN-IA) has received funding from the European Union’s Seventh Framework Programme for research, technological development and demonstration under grant agreement no 284395