Application fees
In accordance with Article 58(1) of the Act of 9 March 2023 on clinical trials on medicinal products for human use (Journal of Laws of 2023, item 605), the sponsor makes an application payment for:
- a clinical trial of medicinal products for human use,
- a substantial amendment to a clinical trial on medicinal products for human use.
Proof of payment of the fee to the Medical Research Agency shall be attached to the application for a clinical trial authorisation.
Fees are to be paid for applications submitted in the CTIS from July 1, 2023.