ECSubmissionOfApplication object
Responsible for study submission
Sponsor
Legal representative domiciled in the respective country
Guidance on study submission available
Yes
Guidance on study submission
A comprehensive guideline providing detailed guidance on format, content and required appendixes of application as well as on the trial conduct (notification on amendments, trial termination etc.) is available (Guidance on The Format of Applications for Clinical Trials and Bioavailability - Bioequivalence Studies to Ethics Committee 2015).
National legal framework in place
Yes
