# 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.

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      <p><strong>Note</strong>: This feature is only available on RIM Registrations Vaults.</p>
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## Components

The following components support bulk XEVMPD update and submission:

  * **Medicinal Product with Medicinal Product Registration**: This [standard report type](/en/lr/39659/) 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](/en/lr/39659/) 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](/en/lr/33725/) 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][3] 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][4] 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][5] 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 Vault API.

### About XEVMPD Elements {#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 {#refresh}

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 (<img class="inline" src="https://platform.veevavault.help/assets/images/XEVMPD_download_19r35.png" alt="download button" style="" />) 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 {#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][7] below.

## Bulk Submitting XEVMPD Data {#bulk-submission}

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](/en/lr/8591/) 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**.

## Related Permissions

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.|

 [3]: #elements
 [4]: #refresh
 [5]: #record-creation
 [7]: #bulk-submission