CASubmissionFee object

Yes

Fees published for 2015 are provided below as a guide, but should be checked at time of application:

(1) Fees for Clinical Trials involving general medicinal products:
- Phase IV: IMP used within terms of MA 269 Euro/IMP used otherwise than in accordance with MA 538 Euro
- Phase I,II,III: IMP containing established active substance 538 Euro/IMP containing new active substance 1443 Euro
- Notice of amendment: 84 Euro

(2) Fees for Clinical Trials involving medicinal products for gene therapy etc.
- Phase IV: IMP used within terms of Marketing Authorisation: 538 Euro/IMP used otherwise than in accordance with MA 1076 Euro.
- Phase I,II,III: IMP containing established active substance 1076euro/IMP containing new active substance 2889euro
- Notice of amendment: 84 Euro
- Review of DSUR: 170 Euro
- Review of DSUR where HPRA are rapporteur under a work-sharing procedure: 1000 Euro

Yes

Prior to submission of application

Fees for applications are laid down in the HPRA (Fees) Regulations, which are made each year by the Minister for Health.
Detailed information is available from the HPRA ‘Guide to Fees for Human Products’, the ‘Fee application form for human products’ from the HPRA website in section: Medicines>Regulatory Information>Medicines fees.

Fees are mandatory to be paid to the CA for clinical trial authorisation according to Regulation 14 SI 190/2004.

HPRA fee form and proof of payment are required at time of clinical trial application.

In circumstances where there is no financial support for the conduct of the clinical trial, the investigator may be entitled to a fee waiver. Any request for a fee waiver should be clearly stated in the cover letter with the clinical trial application.