XEVMPD Bulk Update & Submission (RIM)

Organizations generate XEVMPD data and submit it to the Health Authority at a granular level. However, some updates impact a large number of medicinal products, such as changing the company’s Qualified Person for Pharmacovigilance (QPPV). In Vault, you can select and update the impacted medicinal products in bulk. You can then regenerate the Product Report structure and submit the updated XML to the EMA in bulk.

Components

The following components support bulk XEVMPD update and submission:

  • Medicinal Product with Medicinal Product Registration: This standard report type connects Medicinal Product with Medicinal Product Registration. The XEVMPD Bulk Update action is available on this report type for users with the correct permissions.
  • PDS with Medicinal Product, XEVMPD Validation and PDM: This standard report type connects Product Data Submission with Medicinal Product, Validation Results, and Product Data Messages. The XEVPRM Bulk Submission action is available on this report type for users with the correct permissions.
  • XEVMPD Bulk Update Async Operation: This job creates new Product Data Submission records asynchronously after you complete the bulk update wizard.
  • Change Summary: Vault populates this field on Product Data Submission with the change summary you enter during bulk update.
  • Bulk Action ID: Vault populates this field on Product Data Submission with the Job ID of the bulk processing job.
  • Most Recent Submitted: Vault uses this field to track the most up-to-date submitted product report tree.

Updating the Most Recent Submitted Field

Before you can update XEVMPD data in bulk, you must move the relevant Product Data Submission records to the Submitted lifecycle state. When the Product Data Submission records enter the Submitted state, Vault sets the Most Recent Submitted field to Yes. We recommend using a bulk action to move the Product Data Submission records to the Submitted state.

Bulk Updating XEVMPD Data

To update XEVMPD data in bulk:

  1. Create and run a Medicinal Product with Medicinal Product Registration report.
  2. In the report’s Actions menu, select XEVMPD Bulk Update to start the bulk update wizard.
  3. On the Choose Action page, select the operation you want perform and enter a brief Change Summary.
  4. Click Next.
  5. On the Select Refresh Details page, select the Attachment Format for all product reports created. Vault automatically attaches the viewable rendition if the source document is not available.
  6. Choose a value in the Select XEVMPD Element drop-down and click Apply. Repeat this step for each Medicinal Product element you want to update. Vault automatically adds a section to the page for each element you select. You can load details, select the fields you want to refresh, and download a CSV containing affected medicinal products in each section. See details about refreshing XEVMPD data below.
  7. When you finish selecting XEVMPD data to refresh, click Next.
  8. On the Confirmation page, review the details of the XEVMPD data you are refreshing.
  9. Click Finish. See details about record creation below.

When performing bulk XEVMPD updates, you can update 1,000 records at a time through the UI or 500 records at a time via the API.

About XEVMPD Elements

You can only update certain XEVMPD elements in bulk. For other elements, such as Therapeutic Indication, Vault would need to create new Medicinal Product records if data was added or changed. These elements don’t appear in the wizard.

Refreshing XEVMPD Data

After you select the XEVMPD elements, you can choose which fields to refresh:

  1. Click the Pencil icon next to each element.
  2. In the dialog, use the arrow buttons to move fields from the Source box to the Target box.
  3. When you’ve finished selecting fields, click Save.

The fields you selected appear in the element’s grid with no records. Click the Load Details button to return field values. You can only click the Load Details button once. If you need to see data in additional fields, click the X button next to the element to remove it. Then, select the element again.

If you see unexpected field values, you can click the Download button (download button) in the Affected Medical Products column to download a CSV containing details about the impacted Medicinal Product. Note that you need to enable pop-ups in your browser to download the CSV.

About Record Creation

After you complete the bulk update wizard, Vault attempts to create a new Product Data Submission and related records for each impacted Medicinal Product. Vault creates the new Product Data Submission record with the refreshed data and copies other data from the Product Data Submission record with the Most Recent Submitted field set to Yes.

Vault also updates the Change Summary field on the Product Data Submission record and assigns each new Product Data Submission record the same value in the Bulk Action ID field. You’ll use the Bulk Action ID field when submitting the updated XEVPRM to the EMA. See bulk submission details below.

Bulk Submitting XEVMPD Data

After you make bulk updates to XEVMPD data, you can submit the updated XML to the EMA:

  1. Create a PDS with Medicinal Product, XEVMPD Validation and PDM report.
  2. In the Filters section of the report builder, create a filter for the Bulk Action ID field.
  3. Run the report and review the data.
  4. From the report’s Actions menu, select XEVPRM Bulk Submission. Vault submits the updated XML through the EMA Gateway. Note that you will only receive Vault notifications about Level 3 Acknowledgements when you bulk submit the XEVPRM.
  5. Navigate to the newly-submitted Product Data Submission record and move it to the Submitted lifecycle state. When the new Product Data Submission enters the Submitted lifecycle state, Vault sets Most Recent Submitted to No on the previous Product Data Submission and sets this field on the new Product Data Submission record to Yes.

You must have the following permissions to update and submit XEVMPD data in bulk:

Type Permission Controls
Security Profile XEVMPD / XEVPRM: XEVMPD Bulk Update Ability to update medicinal product data in bulk.
Security Profile XEVMPD / XEVPRM: XEVPRM Bulk Submit Ability to generate the XEVPRM after XEVMPD bulk updates and submit the XML to the EMA.