CASubmissionFee object
Fees for trial submission mandatory
Yes
Fees
Clinical trial authorisation:
- Initial submission- Phase I,II,III: 3800 EURO
- Follow-up trial without re-evaluation of dossier: 1500 EURO
- Follow-up trial with re-evaluation of dossier - Phase 1: 1900 EURO;
- Follow-up trial with re-evaluation of dossier - Phase II-III: 2100 EURO;
- Amendments with need for scientific evaluation: 1100 EURO;
- Other Amendments: 730 EURO
(Version March 2015)
Application for reduced fees is possible in special cases according to Art 3 AMG-Kostenverordnung - AMGKostV (de) -
Waiver for academic (non-commercial) studies possible
Upon request
Applicable national legal framework/ Reference
Applicable authorisation fees are provided in the most recent version of the AMG-Kostenverordnung - AMGKostV (de)