CTD Section 1.3.5.3 Report
Summary
Section Name:
Exclusivity request
Section Code:
1.3.5.3
Module Number:
1
Description:
Document in which a sponsor of a marketing application requests exclusive drug marketing privileges for their licensed product
Submission Timing
Include with marketing applications only
Last Updated:
August 22, 2025 - 04:45 PM
Required with submission of type
Resources