Review a draft Expedited Report

1. Open the case for which you want to view a draft report.
2. Click the Regulatory Reports tab.
3. From the Total Number of Rows tab, locate the relevant report and click Draft to view the report.
4. Alternatively, click the Draft Report icon on the top right of the screen.
   1. From the View Draft pop-up, select the Report Form, Destination, and Product.

      The Report Form drop-down displays the list of expedited reports and the Destination drop-down displays the list of reporting destinations configured in Console. Based on the report form and destination, the products are displayed as explained below:

      • For the Drug Report Forms, the left most suspect product with the drug license that matches the agency country is displayed as default.
      • For the Device Report Forms, the left most suspect product with the device license that matches the agency country is displayed as default.
      • For the Vaccine Report Forms, then left most suspect product with the vaccine license that matches the agency country is displayed as default.

        When no product with license matches to the license type and agency country in the case, then the primary suspect product is displayed, that is left most suspect product in the Product tab.

      • For the Drug Report Forms, the drug license with earliest award date of the selected product that matches the agency country is used to generate reports.
      • For the Device Report Forms, the device license with earliest award date of the selected product that matches the agency country is used to generate reports.
      • For the Vaccine Report Forms, the vaccine license with earliest award date of the selected product that matches the agency country is used to generate reports.
   2. Click OK.

      The report is generated in the draft mode.