CASubmissionFee object

Fees for trial submission mandatory

Yes

Fees

Application with an IMP dossier: 3400 GBP (approx. 4290 EURO)
Application of substantial amendments: 250 GBP (approx. 315 EURO)
No fee for Phase IV notifications

Waiver for academic (non-commercial) studies possible

Not specified

Official guidance on required fees available

Yes

Official guidance on required fees

The "Statutory guidance: Current MHRA fees" is available on the MHRA website.

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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