You are also able to export a dossier for each submission and select specific components within the eCTD structure, if needed. Because the export maintains the same folder structure used during import, you can use this option to leverage exported submissions or components for other regions. Exporting can also simplify the process of distributing dossiers with local affiliates or publishing partners.
To export a submission dossier:
- Navigate to the Submission Mgmt > Submissions tab and open the submission you want to export.
- Choose Export from the All Actions menu.
- From the Refine Selection page, review the structure of components. Select Export entire submission archive to include all components, or use the checkboxes to select specific components or subsections.
- Click Next.
- From the Confirmation page, review the summary. Click Finish to begin exporting.
- You will receive a notification when the process is complete. Click the included link to download a ZIP file.
Note: The export file name will not include the following characters: <,>,:,”“,/,|,?,*
Exporting Large Submissions
If submissions exceed export limits and you have the correct permissions, you can choose to export the submissions to the Vault File Staging Server rather than reducing your export size.
You can find all exported content in the Submissions Archive Export folder, within your personal user folder on the Staging Server. The folder structure and folders match those used during submission import. From here, you can download the export at your convenience. Your export also includes a Manifest log file, an Export Summary file, correspondence documents (if enabled), and a failure log file.
Limits
Vault places some limits on exports:
Exports cannot include more than 50,000 files.
The total export cannot exceed 5.3GB (5368709120 bytes).