CASubmissionOfApplication object
Responsible for study submission
Sponsor
Prerequisites for submission
Positive opinion by relevant EC(s)
Guidance on submission of application
A comprehensive official guidance, based on Law on MP & MD 2010, is available in English on the ALIMS Website in Section: Regulations » Rules for Medical Devices:
'Rulebook on the Contents of the Application, and/or Documentation on the Approval of Clinical Trials for Medicines and Medical Devices, as well as the Method of Implementation for Clinical Trials of Medicines and Medical Devices'
