Studies may be registered by the (primary) lead investigator conducting the study or any person on his/her behalf (e.g. contact person for scientific or public enquiries), or by a sponsor and/or marketing authorisation holder or any person on their behalf.
As the person registering a study or providing subsequent updates to existing study records you confirm that:
The EMA reserves the right to reject applications for study registration deemed incomplete or inadequate. An email will be dispatched within two weeks of submission, either confirming the study has been accepted, or asking for further clarifications.