Declaration to SÚKL – affidavit

It is no longer required, instead of this annex it is necessary to answer directly in the project proposal two questions, namely whether "The project proposal corresponds to the clinical trial of medicines according to the provisions of Act No. 378/2007 Coll., on Medicines" and "The project proposal corresponds to the clinical trial of medical devices according to Act No. 375/2022 Coll., on medical devices and in vitro diagnostic medical devices' (the applicant is responsible for the correctness of the answers). If the answer is in the affirmative, it is necessary to provide, in the case that it corresponds to a clinical trial of medicines, 'an officially certified copy of the decision on the authorisation of a clinical trial for the Czech Republic within the meaning of the Act on Medicinal Products and the same documentation that was approved in this Decision' and, in the case that the proposal corresponds to the conduct of a clinical trial for a medical device, 'an officially certified copy of the authorisation of the SÚKL on the authorisation to conduct a clinical trial for a medical device within the meaning of the Act on Medical Devices'. on medical devices'.