Configure EMA Gateway

Set up an EMA Gateway Profile and Transmission Profile to support submissions through the EudraVigilance.

Note: Vault Safety AS2 Connections are replacing Vault Safety Gateways. AS2 Connections provide significant technical improvements including Admin management of Internet Protocol (IP) lists, more concise outbound IP lists, and improved Certificate Management. Though Gateways are still supported, we recommend configuring your Vault to use an EMA AS2 Connection instead of the EMA Gateway.

About Vault Safety EudraVigilance Integration

Vault Safety supports electronic reporting to EudraVigilance through AS2 (system-to-system) communication.

You must set up a Gateway Profile and a corresponding Transmission Profile for users to report cases to EudraVigilance and receive gateway responses.

Note: If your organization is a CRO making Submissions on behalf of clients, you must complete each of the steps on this page separately for each sponsor, including setting up a new EudraVigilance Account and obtaining new certificates per sponsor.

Configure a EudraVigilance Account

Before you can configure the Vault Safety EudraVigilance Gateway Profile, you must have an active EudraVigilance account. The EMA Website provides instructions to register with EudraVigilance.

Public and Private Certificates

As part of the EMA registration process, you must obtain a public and private certificate pair and send the public certificate to the EMA. If you need help generating these certificates, contact Veeva Managed Services.

Gateway Connection Settings

When you configure your EudraVigilance account, ensure that you complete the Connectivity Form to match the EMA EU EV Gateway Profile settings in your Vault.

View Vault Gateway Settings

View your connection settings from the Admin > Settings > Gateway Profiles > EU EMA EV page.

Complete the EMA Connectivity Form

Once you have the EU EMA EV Gateway Profile information for your Vault, use these settings to complete the EMA Connectivity Form from the EMA Website.

The following table provides more information on the EMA Connectivity Form settings:

Setting	Description
AS2 IP Address	The AS2 IP address is not required
AS2 Hostname	The domain name in your Vault AS2 URL. For example: `https://vern-safety.veevavault.com`
EMA Receive Port (Vault Transmit Port)	The receive port for the EMA is `8080`. This is the transmit port that Vault Safety uses when sending outbound Transmissions. When submitting the EMA Gateway connectivity form this value should be entered as the Transmit Port.
EMA Transmit Port (Vault Receive Port)	The transmit port for the EMA is `4080`. This is the receive port that Vault Safety uses when receiving inbound Transmissions. When submitting the EMA Gateway connectivity form this value should be entered as the Receive Port.
Exchange Point	The path following `:4080` in the Vault AS2 URL For example: `/gateway/inboundV2/eu-ema-ev`
AS2 ID	The organization ID registered with the EMA

Configure Sender User

For Submissions to the EMA, you must enter full contact details for the Sender User. This user’s information will appear in generated forms and E2B files. The Sender User is assigned on Submission records in the Sender (User) field.

Managing Roles & Security in Vault Safety provides more information on setting up user contact details.

An administrator can configure the EMA Transmission Profile to populate this field with a default Sender User on system generated transmissions based on the Transmission Profile.

Configure the Vault Safety Gateway Profile

Vault comes provisioned with an inactive standard profile for the EMA. In order for users to send Submissions to the EMA, you must configure and activate the Gateway Profile.

In the Admin area, go to the Settings tab.
In the left pane, select Gateway Profiles.
Select EU EMA EV. The Gateway Profiles page appears for the EU EMA EV profile.
Select Edit. The profile page is unlocked for editing.
Under Details, in the Sponsor Email Address field, enter the Vault user email address to be used as a contact in gateway transmissions.
Under AS2 Profile Configuration, complete the following fields:
- Vault AS2 URL: This field is read-only. Verify that the DNS configured in the EudraVigilance account exactly matches the URL in this field.
- Sponsor Certificate: Select Choose, and then open the private encryption certificate used to register with EudraVigilance. The private certificate is usually a .pfx file.
- Sponsor Certificate Password: Enter the password for the sponsor certificate.
- Sponsor ID: Enter the sponsor ID registered with EudraVigilance.
- Health Authority Certificate: Select Choose, and then open the public encryption certificate received from EudraVigilance during registration. The public certificate is usually a .p7b file.
- Health Authority ID: Enter one of the following EMA identification codes:
  - For a production account, enter EVHUMAN.
  - For a test account, enter EVTEST.
    Whether you will be submitting study or post-market cases, enter one of these values. You can specify the destination gateway endpoint in the Transmission Profile.
- Health Authority URL: Enter one of the following destination EudraVigilance Gateway URLs:
  - For a production account, enter http://pgateway.ema.europa.eu:8080/exchange/EVHUMAN.
  - For a test account, enter http://vgateway.ema.europa.eu:8080/exchange/EVTEST.
- Gateway User: Select the Vault Safety user whose name should appear in audit logs and gateway transactions.
Select Save.
To activate the profile, on the top-right corner, select Set Active.

Note: The Gateway User Required checkbox is automatically populated by the system and is informational only.

Result

The EU EMA EV Gateway Profile is active and available to use to submit case reports to the EMA.

Configure EMA Transmission Profiles

Vault Safety comes with standard, system-provided Transmission Profiles for EMA Submissions. You must configure these Transmission Profiles as part of the EMA gateway setup.

The following table lists the system-provided EMA Transmission Profiles:

Transmission Profile	Usage
EVHUMAN	Submissions to the EudraVigilance Post-Authorisation Module (EVPM).
EVCTMPROD	Submissions to the EudraVigilance Clinical Trial Module (EVCTM).

Manage Transmission Profiles provides instructions on setting up Transmission Profiles.

When setting up the Transmission Profiles, see the following guidance on setting the Origin and Destination IDs:

Origin ID: Enter the sponsor ID registered with EudraVigilance.
Destination ID: Enter one of the following destination IDs for the appropriate Eudravigilance Gateway:
- For a production EVCTM account, enter EVCTMPROD.
- For a test EVCTM account, enter EVCTMTEST.
- For a production EVHUMAN account, enter EVHUMAN.
- or a test EVHUMAN account, enter EVTEST.

Once you set up the EMA Transmission Profiles, the system uses the appropriate Transmission Profile to generate Submissions based on your Vault’s EMA reporting rules.