CASubmissionFee object

Fees for trial submission mandatory

Yes

Fees

For initial clinical trial applications:
3000 € for clinical trials Phase I-III
1508 € for clinical trials Phase IV
Substantial amendment 500 €
Non-interventional studies 603 €.

NB: From 01.01.2016, non-commercial clinical (academic) trials are no longer exempt from fees upon application:
20% of applicable fees for clinical trials Phase I-III & IV (one-time charge!).
No fees for substantial amendments or inspections.

Waiver for academic (non-commercial) studies possible

Reduced fees are charged

Official guidance on required fees available

Yes

Official guidance on required fees

Latest version of “BASG Gebührentarifverordnung gemäß Gesundheits- und Ernährungssicherheitsgesetz GESG" (Regulation on Fees), published on the BASG/AGES website (also available in English).

National legal framework in place

Yes

Applicable national legal framework/ Reference

BASG Gebührentarifverordnung gemäß Gesundheits- und Ernährungssicherheitsgesetz GESG (de)/ Regulation on Fees (en);
Waiver for academic studies: Art 1a. (2)

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