To prepare a submission for import, locate the submission’s ZIP file from your third-party publishing tool that contains the submission content you submitted to the Health Authority.
We recommend creating one (1) folder in your storage location for each application and storing each submission’s ZIP file and unzipped contents in a submission folder inside the application folder. This folder structure helps ensure that all submissions for an application are in a central location, which makes it easier to locate the appropriate submission folder when sending a submission to your third-party publishing tool and when importing a submission to RIM Basics: Submissions Archive.
Ensure that the submission ZIP file contains content for one (1) submission only. For eCTD submissions, Vault expects the submission folder to contain the index.xml file created by your third-party publishing tool.
Before importing a submission ZIP file, ensure that you have populated the following fields:
- In the Details section of the associated application, ensure that you have entered the Application Folder Name using the format expected by the Health Authority, if applicable.
- In the Details section of the associated submission, ensure that you have selected the Dossier Format.
- In the Planning and Tracking Details section of the associated submission, ensure that you have entered the Sequence ID.