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 for information about attachment-only submissions.
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 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:
- Navigate to the Product Data Submission record.
- From the record’s Actions menu, choose Submit XEVPRM. This label may vary based on your vault’s configuration.
- 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.
- 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.
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:
|Product Data Message||Message Dispatch Date||The date and time the XEVPRM message entered the queue for submission to the EMA.|
|Product Data Message||Submitted By||The user who initiated the Submit XEVPRM action. Vault notifies this user of all changes and updates from the EMA.|
|Product Data Message||MDN Received||The date and time that Vault received the initial MDN from the EMA, indicating the EMA has received the submission.|
|Product Data Message||Level 1 Acknowledgement Received||The date and time Vault receives the Level 1 Acknowledgement from the EMA.|
|Product Data Message||Level 1 Result||The result of the Level 1 Acknowledgement from EMA.|
|Product Data Message||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.|
|Product Data Message||Level 2 Result||The operation result from the Level 2 Acknowledgement from the EMA.|
|Product Data Message||Level 3 Acknowledgement Received||The date and time Vault receives the Level 3 Acknowledgement from the EMA.|
|Product Data Message||Level 3 Result||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 Attachments section for the full text.|
|Product Data Message||XEVPRM Submission Status||
The current EMA communication status for this Product Data Message:
|XEVMPD Acknowledgement||Attachment EV Code*||The EV Code assigned to the attached document in the Level 2 Acknowledgement header.|
|XEVMPD Acknowledgement||Document EV Code*||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.|
|XEVMPD Acknowledgement||Level 1 Result||The result of the Level 1 Acknowledgement from EMA.|
|XEVMPD Acknowledgement||Level 2 Result||The operation result from the Level 2 Acknowledgement from the EMA.|
|XEVMPD Acknowledgement||Level 3 Result||The full text from the Level 3 Acknowledgement from the EMA. Vault truncates this field if the text is longer than 10,000 characters.|
|XEVMPD Acknowledgement||Local Number*||The unique local number assigned to the attached document in the Vault library. Vault uses this number to identify the report in the XML.|
|XEVMPD Acknowledgement||Version||The version number in the EMA acknowledgements. Vault updates this field after receiving the Level 2 and Level 3 Acknowledgements.|
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
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 EMA website 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.
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 to compare expected timelines against the current status to alert you if an issue occurs or if you don’t receive an expected acknowledgement.
You must have the following permissions to work with submit medicinal product data to the EMA XEVMPD gateway:
Objects: Product Data Message: Read
Ability to view and access the XEVPRM message and ZIP file and access the Submit XEVPRM action.
Objects: Product Data Submission: Create, Edit
Ability to create and edit Product Data Submission records and access the Submit XEVPRM action.
Objects: XEVMPD Acknowledgement: Read
Ability to see the acknowledgement details from the EMA.