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 provided information is true, accurate, current and complete;
• the information provided may be used according to the EMA Privacy Statement;
• you accept responsibility for all activities related to the use of your login details or password provided upon registration;
• it is your responsibility to enter the information required for registration and to keep this information up-to-date at all times;
• you commit to reviewing and updating your study records regularly;
• you acknowledge that all information is accessible to the public via the EU PAS Register portal maintained by EMA.

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.