# XEVMPD Gateway Submission for Medicinal Products (RIM)

After you finish compiling medicinal product data, Vault's integration with the EMA Gateway allows you to submit the generated XEVPRM to the Health Authority electronically and receive gateway responses. See [XEVMPD Gateway Submission for Attachments](/en/lr/71609/) for information about attachment-only submissions.

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      <p><strong>Note</strong>: This feature is only available on RIM Registrations vaults.</p>
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## How the EMA Gateway Integration Works

The EMA Gateway allows for the secure submission of XEVMPD data and enables you to submit generated XEVPRM messages to the EMA.

With gateway integration, Vault submits the message to the EMA and provides status details for the transfer. Vault adds responses from the EMA, known as acknowledgements, as attachments to the _Product Data Message_ and _XEVMPD Acknowledgement_ records and updates related fields, allowing you to track and manage acknowledgements from the EMA within Vault. The user who submitted the message receives Vault notifications for all updates from the EMA.

## Submitting to the EMA Gateway

To submit a _Product Data Submission_ to the EMA Gateway:

  1. Navigate to the _Product Data Submission_ record.
  2. From the record's **Actions** menu, choose **Submit XEVPRM**. This label may vary based on your vault's configuration.
  3. In the **Submit XEVPRM** confirmation dialog, review the information. The dialog provides a summary of the messages to be submitted and any warnings for you to confirm before queuing the submission for transfer to the EMA.
  4. Click **Submit**.

You can also submit individual XEVPRM messages directly from a _Product Data Message_ record. Select **Submit XEVPRM** from the record's **Actions** menu and acknowledge the information in the confirmation dialog.

### Notifications

When you submit medicinal product data to the EMA Gateway, you receive an email and a Vault notification. Both success and failure notifications include a link to the _Product Data Submission_ or _Product Data Message_ within Vault, depending on the record from which you submitted data.

You can check the status of your submission in the _XEVPRM Submission Status_ field on the _Product Data Message_ record. When the EMA receives your submission, you'll also receive a Message Delivery Notification (MDN). Vault tracks this via the _MDN Received_ field on your _Product Data Message_ record, adds the MDN as an attachment to the record, and sends you a notification and email.

### Associated Object Fields

Vault uses the following objects and fields to track status after you submit the XEVPRM through the EMA Gateway:

<table class="wbord">
  <tr>
    <td>
      <strong>Object</strong>
    </td>
    <td>
      <strong>Field</strong>
    </td>
    <td>
      <strong>Function</strong>
    </td>
  </tr>
  <tr>
    <td>
      Product Data Message
    </td>
    <td>
      Message Dispatch Date
    </td>
    <td>
      The date and time the XEVPRM message entered the queue for submission to the EMA.
    </td>
  </tr>
  <tr>
    <td>
      Product Data Message
    </td>
    <td>
      Submitted By
    </td>
    <td>
      The user who initiated the <em>Submit XEVPRM</em> action. Vault notifies this user of all changes and updates from the EMA.
    </td>
  </tr>
  <tr>
    <td>
      Product Data Message
    </td>
    <td>
      MDN Received
    </td>
    <td>
      The date and time that Vault received the initial MDN from the EMA, indicating the EMA has received the submission.
    </td>
  </tr>
  <tr>
    <td>
      Product Data Message
    </td>
    <td>
      Level 1 Acknowledgement Received
    </td>
    <td>
      The date and time Vault receives the Level 1 Acknowledgement from the EMA.
    </td>
  </tr>
  <tr>
    <td>
      Product Data Message
    </td>
    <td>
      Level 1 Result
    </td>
    <td>
      The result of the Level 1 Acknowledgement from EMA.
    </td>
  </tr>
  <tr>
    <td>
      Product Data Message
    </td>
    <td>
      Level 2 Acknowledgement Received
    </td>
    <td>
      The date and time Vault receives the Level 2 Acknowledgement from the EMA. This may be the same date and time as the Level 1 Acknowledgement if there were no Level 1 errors.
    </td>
  </tr>
  <tr>
    <td>
      Product Data Message
    </td>
    <td>
      Level 2 Result
    </td>
    <td>
      The operation result from the Level 2 Acknowledgement from the EMA.
    </td>
  </tr>
  <tr>
    <td>
      Product Data Message
    </td>
    <td>
      Level 3 Acknowledgement Received
    </td>
    <td>
      The date and time Vault receives the Level 3 Acknowledgement from the EMA.
    </td>
  </tr>
  <tr>
    <td>
      Product Data Message
    </td>
    <td>
      Level 3 Result
    </td>
    <td>
      The results of the Level 3 Acknowledgement from the EMA. If the results are longer than 10,000 characters, Vault truncates this field. Refer to the acknowledgement message in the <em>Attachments</em> section for the full text.
    </td>
  </tr>
  <tr>
    <td>
      Product Data Message
    </td>
    <td>
      XEVPRM Submission Status
    </td>
    <td>
      The current EMA communication status for this <em>Product Data Message</em>:
      <ul>
        <li>
          <em>Queued for Submission</em>
        </li>
        <li>
          <em>Transmission Failed</em>
        </li>
        <li>
          <em>MDN Received</em>
        </li>
        <li>
          <em>Transmission Successful</em>
        </li>
        <li>
          <em>Level 1 Acknowledgement Received</em>
        </li>
        <li>
          <em>Level 2 Acknowledgement Received</em>
        </li>
        <li>
          <em>Level 3 Acknowledgement Received</em>
        </li>
        <li>
          <em>Re-Queued by System</em>
        </li>
      </ul>
      Vault updates this field each time the status changes.
    </td>
  </tr>
  <tr>
    <td>
      XEVMPD Acknowledgement
    </td>
    <td>
      Attachment EV Code<a class="in-cell-link" href="#field-available" rel="noopener">*</a>
    </td>
    <td>
      The EV Code assigned to the attached document in the Level 2 Acknowledgement header.
    </td>
  </tr>
  <tr>
    <td>
      XEVMPD Acknowledgement
    </td>
    <td>
      Document EV Code<a class="in-cell-link" href="#field-available" rel="noopener">*</a>
    </td>
    <td>
      The EV Code assigned to the attached document in the Vault library. Vault populates this field with the first EV Code received for the document, even if the EMA sends multiple Level 2 Acknowledgements.
    </td>
  </tr>
  <tr>
    <td>
      XEVMPD Acknowledgement
    </td>
    <td>
      Level 1 Result
    </td>
    <td>
      The result of the Level 1 Acknowledgement from EMA.
    </td>
  </tr>
  <tr>
    <td>
      XEVMPD Acknowledgement
    </td>
    <td>
      Level 2 Result
    </td>
    <td>
      The operation result from the Level 2 Acknowledgement from the EMA.
    </td>
  </tr>
  <tr>
    <td>
      XEVMPD Acknowledgement
    </td>
    <td>
      Level 3 Result
    </td>
    <td>
      The full text from the Level 3 Acknowledgement from the EMA. Vault truncates this field if the text is longer than 10,000 characters.
    </td>
  </tr>
  <tr>
    <td>
      XEVMPD Acknowledgement
    </td>
    <td>
      Local Number<a class="in-cell-link" href="#field-available" rel="noopener">*</a>
    </td>
    <td>
      The unique local number assigned to the attached document in the Vault library. Vault uses this number to identify the report in the XML.
    </td>
  </tr>
  <tr>
    <td>
      XEVMPD Acknowledgement
    </td>
    <td>
      Version
    </td>
    <td>
      The version number in the EMA acknowledgements. Vault updates this field after receiving the Level 2 and Level 3 Acknowledgements.
    </td>
  </tr>
</table>

<a id="field-available"></a>\*This field is only available on *XEVMPD Level 2*-type _XEVMPD Acknowledgement_ records.

### Limitations & Errors

You can't submit the XEVPRM when:

* A _Product Data Message_ record contains an _XML Validation Result_ CSV file with the same file name as the message name; this indicates the XML is invalid and would immediately receive a Level 1 failure acknowledgement
* The _Product Data Message_ record is missing the XEVPRM XML file
* The _Product Data Message_ record has more than one XEVPRM ZIP file attached
* The _XEVPRM Submission Status_ field on the _Product Data Message_ record has a value other than **Null** or **Transmission Failed**; this indicates there is an active submission in progress

## Acknowledgement Responses

After you receive the initial MDN, the EMA Gateway delivers three (3) different acknowledgements: a Response Acknowledgement, a Report Acknowledgement, and a Validation Acknowledgement. See the <a class="external-link " href="https://www.ema.europa.eu/en/documents/other/chapter-5-extended-eudravigilance-product-report-acknowledgement-message-detailed-guidance_en.pdf" target="_blank" rel="noopener">EMA website<i class="fa fa-external-link" aria-hidden="true"></i></a> for detailed information about EMA responses.

Each time the EMA sends an acknowledgement response, Vault notifies you of the response and creates a new _XEVMPD Acknowledgement_ record. The object type of the new _XEVMPD Acknowledgement_ record corresponds to the EMA's acknowledgement response level. For example, when the EMA sends a Response Acknowledgement, Vault creates an _XEVMPD Acknowledgement_ record of type _XEVMPD Level 1_. To view the _XEVMPD Acknowledgement_ records, navigate to the _Product Data Message_ record and expand the related section.

Additionally, Vault adds acknowledgement messages to the _Product Data Message_ and _XEVMPD Acknowledgement_ records as attachments and populates fields on both records. Note that you may receive duplicate acknowledgements from the EMA if an issue occurs during processing. We recommend contacting the EMA Service Desk or Veeva Support.

### About EV Codes

When the EMA sends the first Level 2 Acknowledgement, Vault populates the _EV Code_ field on the attached document. In some cases, a document may be included in more than one XEVMPD submission, or the EMA may send more than one Level 2 Acknowledgement. When this occurs and the document's local code is the same, Vault does not repopulate the document's _EV Code_ field. Instead, Vault preserves the value from the first Level 2 Acknowledgement received and notifies you that the field has not been updated.

### Unexpected EMA Responses

If Vault receives any unexpected responses that could be malicious, Vault sends you a notification and deletes the message.

## Reporting

Vault sends you emails and notifications throughout the submission process, including each time you receive an acknowledgement, when there are submission failures, or when messages are missing.

We recommend [configuring a flash report](/en/lr/51842/) to compare expected timelines against the current status to alert you if an issue occurs or if you don't receive an expected acknowledgement.

## Related Permissions

You must have the following permissions to work with submit medicinal product data to the EMA XEVMPD gateway:

<table class="wbord">
  <tr>
    <td>
      <p>
        <strong>Type</strong>
      </p>
    </td>
    <td>
      <p>
        <strong>Permission Label</strong>
      </p>
    </td>
    <td>
      <p>
        <strong>Controls</strong>
      </p>
    </td>
  </tr>
  <tr>
    <td>
      <p>
        Security Profile
      </p>
    </td>
    <td>
      <p>
        Objects: Product Data Message: Read
      </p>
    </td>
    <td>
      <p>
        Ability to view and access the XEVPRM message and ZIP file and access the <strong>Submit XEVPRM action</strong>.
      </p>
    </td>
  </tr>
  <tr>
    <td>
      <p>
        Security Profile
      </p>
    </td>
    <td>
      <p>
        Objects: Product Data Submission: Create, Edit
      </p>
    </td>
    <td>
      <p>
        Ability to create and edit <em>Product Data Submission</em> records and access the <strong>Submit XEVPRM</strong> action.
      </p>
    </td>
  </tr>
  <tr>
    <td>
      <p>
        Security Profile
      </p>
    </td>
    <td>
      <p>
        Objects: XEVMPD Acknowledgement: Read
      </p>
    </td>
    <td>
      <p>
        Ability to see the acknowledgement details from the EMA.
      </p>
    </td>
  </tr>
</table>