CASubmissionFormat object

Format option(s)

Paper + electronic file

Standard application form

Notification resp. request for authorization of a clinical trial shall be made using the Clinical Trial Application (CTA) Form available on the EMA- EudraCT database website.

Guidance on submission format

Section 6 -8 of Regulation 2/2012

Applicable national legal framework/ Reference

Section 6 -8 of Regulation 2/2012