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Fees for Assessment of PART II of CT Applications Submitted via CTIS

Important notice for applicants for clinical trial authorisations submitted via CTIS (EU portal).  

As of December 2022, the assessment of application process will newly involve also multicentric ethics committees. The ethics committee will be designated by SÚKL. For this reason, all applicants are kindly asked not to submit the payment of fees for expert activities for PART II at the time of submission of the application and to wait for the designation of the ethics committee. Thereafter, the applicants shall pay the fees for expert activities to the healthcare service provider that has established the designated ethics committee. The request for validation of the concerned clinical trial will contain information on which ethics committee has been designated and what payment is to be evidenced no later than at the time of the issuance of the Conclusion by the ethics committee. Billing data of ethics committees will be published on our website and on the websites of ethics committees.

19 December 2022

Department of Clinical Trials on Medicinal Products