- Veeva RIM Basics Admin or Submission Manager
This work instruction is for Vaults with a Veeva RIM Basics: Submissions Publishing license.
A regulatory application is a formal submission comprising a set of documents made to a regulatory authority, such as the Food and Drug Administration (FDA) in the United States or the European Medicines Agency (EMA) in the European Union, to obtain approval for the development, testing, or marketing of a product.
In Veeva RIM Basics, an Application can contain multiple Submissions, each with the same core data. After the Vault Administrator has set up the core RIM product data, you can begin working on your first submission. The first step is to create the application.
To create an application:
-
Navigate to Submission Mgmt > Submission Mgmt > Applications and click Create.
-
Select the Type of Application and click Continue.
-
Enter the Application Name and Lead Market, which automatically populates the Region, along with the remaining details on the left.
-
Specify the Dossier Format (eCTD or non-eCTD) and the Application Folder Name, as it appears at the Health Authority.
-
At the Application level, the Publish in Vault field sets the default for any new Submissions created for this application.
-
Specify the Content Plan Details. These are specific to the lead market, region, and dossier format for this application.
-
If Publish in Vault is set to Yes, open the Publishing Details section and provide the XML Application Number and Applicant.
-
Specify the Primary Health Authority and Health Authority Center you will be sending submissions for this application to, along with the Validation Criteria Version. Note: Some Health Authorities, like the FDA, have multiple centers. Be careful to select the correct center.
-
Click Save.
