CASubmissionFee object

Fees for trial submission mandatory

Yes

Fees

- Clinical trials: 3000-9900 EURO
- Substantial Amendments: 600- 1700 EURO
- Waiver of authorisation: 500 -2000 EURO
- Notification of SAE: 25 - 250 EURO
(Last amendment: Nov 2014)

Official guidance on required fees

Applicable fees according to the most recent version of the "Medizinprodukte- Gebührenverordnung - BKostV-MPG" (MDA Fees Ordinance Devices) are provided for download on the BfArM website in German and English (unofficial translation) in section Service/Costs

National legal framework in place

Yes

Applicable national legal framework/ Reference

"Medizinprodukte- Gebührenverordnung - BKostV-MPG" (MDA Fees Ordinance)

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
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