XEVMPD Gateway Submission for Attachments (RIM)

When an XEVMPD attachment document reaches an approved state, Vault can generate and submit the XEVPRM message for only that document. Attachment-only submissions ensure that a document is only assigned a single EV code and prevents you from needing to maintain multiple EV codes for the same attachment document. You can then include this document as an attachment on a Medicinal Product record to include it in full XEVMPD submissions from a Product Data Submission record, with the document’s EV code already applied.

Note: This feature is only available on RIM Registrations Vaults.

How the EMA Gateway Integration Works

The EMA Gateway allows for the secure submission of attachment-only 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 acknowledgments, as attachments to the document, allowing you to track and manage acknowledgments from the EMA within Vault. Your Admin determines which users and groups receive Vault notifications for updates from the EMA.

Submitting Attachments to the EMA Gateway

Depending on your Vault’s configuration, Vault may automatically generate and submit the XEVPRM when the attachment document reaches a specific state. If XEVPRM generation doesn’t occur automatically, you may be able to select the Submit XEVPRM action from the document’s Actions menu. See Limitation & Errors for more information about when the action is available.

When the action runs, Vault generates the XML and ZIP file, adds the ZIP file to the document as an attachment, performs technical validation, and submits the XEVPRM through the EMA gateway. See XEVMPD Data Review & Validation for more information about XEVPRM generation and XML validation.

Limitations & Errors

The Submit XEVPRM action is not available when one or more of the following criteria are met:

The EV Code field is already populated on the document
The XEVPRM Attachment Only Submission Status field is already populated on the document
The Attachment Format field is blank
The document has more than one assigned language
The document has more than one assigned Application

Additionally, Vault can’t submit the XEVPRM for an attachment document if the XML validation fails.

Notifications

When the attachment-only XEVPRM is sent to the EMA Gateway, Vault sends an email and notification to the groups defined by your Admin. Both success and failure notifications include a link to the document within Vault.

You can check the status of your submission in the XEVPRM Attachment Only Submission Status field on the document. When the EMA receives your submission, you’ll also receive a Message Delivery Notification (MDN). Vault tracks this via the MDN Received field on the document, adds the MDN as an attachment to the document, and sends a notification and email to users in the appropriate groups.

Associated Document Fields

Vault uses the following document fields to track status after an attachment-only submission to the EMA Gateway:

Field	Function
AS2 Message	The message's transmission ID.
Attachment Format	The attachment format for the XEVMPD attachment-only submission (Viewable Rendition or Source Document).
EV Code	The EV code that the EMA assigned to the document.
Level 1 Acknowledgement Received	The date and time Vault receives the Level 1 Acknowledgement from the EMA.
Level 1 Acknowledgement Result	The result of the Level 1 Acknowledgement from the EMA.
Level 2 Acknowledgement Received	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.
Level 2 Acknowledgement Result	The result of the Level 2 Acknowledgement from the EMA.
MDN Received	The date and time that Vault received the initial MDN from the EMA, indicating the EMA has received the submission.
XEVMPD Attachment Only Submission Status	The current EMA communication status for this document: Message Sent Queued for Submission Transmission Failed Transmission Successful Level 1 Acknowledgement Received Level 2 Acknowledgement Received Vault updates this field each time the status changes.
XEVPRM Message Integrity Check	The integrity check code for the AS2 message submitted to the EMA.
XEVPRM Message Receiver	The label that is registered with the EMA.

Acknowledgment Responses

After you receive the initial MDN, the EMA Gateway delivers two (2) different acknowledgments for attachment-only submissions: a Response Acknowledgement and a Report Acknowledgement. See the EMA website for detailed information about EMA responses.

Each time the EMA sends an acknowledgment response, Vault notifies the appropriate users of the EMA response, updates the appropriate fields on the document, and adds the acknowledgment as an attachment on the document. You may receive duplicate acknowledgments 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 Level 2 Acknowledgement, Vault populates the EV Code field on the attachment document.