CASubmissionFee object

Fees for trial submission mandatory

Yes

Fees

- Clinical investigation: 3000 €
- Substantial amendment: 500 €

Clinical investigations on a medical device submitted together with a related medicinal product by the same applicant. In this case, the total fee for a clinical investigation on medical devices plus 35 % of the set fee for clinical trials on medicinal products (3000 € Phase I-III, 1500€ Phase IV) will be charged.

NB: From 01.01.2016, new fees for non-commercial (academic) studies apply:
20% of regular fees for notification of a clinical investigation of a medical device or a performance test
validation of an IVD (one-time charge!)
No fees for substantial amendments or inspections are charged.

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
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