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.
Note This step is only applicable to Vaults with a Veeva RIM Basics: Submissions Publishing licenseSpecify 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 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 licenseClick Save.
