Create an Application

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:

1. Navigate to Submission Mgmt > Submission Mgmt > Applications and click Create.

   

2. Select the Type of Application and click Continue.

   

3. Enter the Application Name and Lead Market, which automatically populates the Region, along with the remaining details on the left.

4. Specify the Dossier Format (eCTD or non-eCTD) and the Application Folder Name, as it appears at the Health Authority.

5. At the Application level, the Publish in Vault field sets the default for any new Submissions created for this application.

   Note This step is only applicable to Vaults with a Veeva RIM Basics: Submissions Publishing license

6. Specify the Content Plan Details. These are specific to the lead market, region, and dossier format for this application.

   

7. If Publish in Vault is set to Yes, open the Publishing Details section and provide the following:

   • XML Application Number - Typically just the number of your application.
   • Applicant - Sponsor, applicant, or holder of your application.
   • Primary Heath Authority - Heath Authority associated with your application.
   • Health Authority Center - Some Health Authorities, like the FDA, have multiple centers. Be careful to select the correct center.
   • Expected Acknowledgements - Number of gateway acknowledgements expected from the Heath Authority Center. Automatically populates based on the selected Health Authority Center.
   • Validation Criteria Version - Make sure to select the validation criteria version that matches the health authority center you selected.
   Note This step is only applicable to Vaults with a Veeva RIM Basics: Submissions Publishing license

8. Click Save.

   

Edit an Application

1. Navigate to Submission Mgmt > Submission Mgmt > Applications and select an application.
2. Click Edit ().
3. Edit the information as needed.
4. Click Save.

Edit an Application Relationship

1. Navigate to Submission Mgmt > Submission Mgmt > Applications and select an application.
2. Select the application relationship you want to edit.
3. From the All Actions menu to the right of the relationship name, select Edit, Delete, or Remove. The available actions are different for each relationship type.
4. If you select Edit, edit the information and click Save.
5. If you select Delete or Remove, click Continue to confirm.

Change an Application Type

You can change an application’s type from Marketing to Investigational, or from Investigational to Marketing.

1. Navigate to Submission Mgmt > Submission Mgmt > Applications and select an application.
2. Select Change Type from the All Actions menu.
3. Confirm that you are changing the type to Marketing or Investigational and click Continue.
4. Select the new Application Type for your Marketing or Investigational application. The available values depend on the selected product type, lead market, and region.
5. Click Save.

Deactivate & Reactivate an Application

If an application is no longer needed and should not be used to create any further submissions, you can deactivate it. The Submission Wizard is unavailable for Inactive applications. You can also reactivate Inactive applications if needed.

1. Navigate to Submission Mgmt > Submission Mgmt > Applications and select an application.
2. Select Change State to Inactive from the Workflow menu.
3. Click Yes to confirm.
4. To reactivate an Inactive application, select Change State to Active from the Workflow menu.
5. Click Yes to confirm.