Configure MHRA Gateway

Set up a Vault Safety UK MHRA Gateway profile to support submissions through the MHRA Gateway.

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 MHRA AS2 Connection instead of the MHRA Gateway.

About Vault Safety MHRA Gateway Integration

Vault Safety supports the United Kingdom Medical and Healthcare products Regulatory Agency (UK MHRA) Gateway through AS2 (system-to-system) communication. The UK MHRA Gateway can be used for ICSR submissions to the MHRA in the EMA E2B (R3) file format. Vault Safety defines the case criteria for these submissions using the MHRA Rule Set, which is based on the EMA ICSR Reporting Rule Set.

Vault’s integration with the UK MHRA allows you to set up a Gateway Profile to submit ICSRs directly from Vault Safety 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 MHRA Account and obtaining new certificates per sponsor.

Prerequisites

You must perform the following one-time configuration changes before you can set up MHRA Gateway submissions:

Activate MHRA as a Standard Organization
Update Country Records

Prerequisite: Activate MHRA as a Standard Organization

MHRA comes preconfigured in each Vault as a standard Organization. In certain Vaults, an Admin must make the Agency active.

Complete the following steps if MHRA is inactive in your Vault:

Go to Business Admin > Objects > Organizations.
Open the MHRA (UK) Agency record.
Select the All Actions menu.
Select Change State to Active.

Note: The Change State to Active user action only appeard if it has been configured in your Vault. Add User Action to the Organization Lifecycle provides instructions for this configuration.

Prerequisite: Update Country Records

From January 1, 2021, all products authorized in Great Britain must have their ICSRs submitted to the MHRA owing to Brexit, the United Kingdom’s formal exit from the European Union. ICSRs for products authorized in Northern Ireland should be submitted to the EMA. For more information, visit the United Kingdom’s Pharmacovigilance Procedures website.

To ensure all new cases reference the correct country and agency, we recommend you update the existing United Kingdom of Great Britain and Northern Ireland record in your Vault to separate Great Britain and Northern Ireland records.

Complete the following steps to update the country records:

Update Existing Country Record to the United Kingdom (Great Britain) Record
Create the United Kingdom (Northern Ireland) Record

Update Existing Country Record to the United Kingdom (Great Britain) Record

Go to Business Admin > Objects > Countries.
Search for United Kingdom of Great Britain and Northern Ireland and select it. The Country page appears.
Select Edit.
Under Details, update the following fields:
- Name: Enter United Kingdom (Great Britain).
- Code (2-letter): Enter GB.
- Code (3-letter): Enter GBR.
- Agency: Select MHRA (UK) from the picklist.
Select Save.

Note: We recommend updating the existing country record as detailed above instead of changing its state to Inactive and creating a new record for Great Britain. Owing to an overlap in Code (3-letter) values, doing so will cause E2B imports to fail.

Create the United Kingdom (Northern Ireland) Record

Go to Business Admin > Objects > Countries.
Select Create. The Create Country page appears.
Under Details, complete the following fields:
- Name: Enter United Kingdom (Northern Ireland).
- Code (2-letter): Enter XI.
- Code (3-letter): Enter GBR.
- Agency: Select EMA from the picklist.
Select Save.

Result

Your Vault has two updated country records.

Note: Once the country records have been updated, it is recommended that pre-existing products and cases should be reviewed and updated with the correct country and agency. For more information, see the EMA’s Northern Ireland Submission Guidelines.

Configure a UK MHRA AS2 Account

Before you can configure the Vault Safety Gateway Profile, you must have an active UK MHRA AS2 account. The MHRA website provides instructions to set up the gateway registration.

Public and Private Certificates

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

Copy Your Vault AS2 URL

When you configure your UK MHRA account, ensure that AS2 URL exactly matches the Vault AS2 URL for your Vault. The following steps will help you in this process:

Go to Admin > Settings > Gateway Profiles.
Open the UK MHRA Gateway Profile.
Under Vault AS2 URL, select Copy URL.

Configure Sender User

For Submissions to the MHRA, 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 Admin can configure the MHRA 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 UK MHRA. In order for users to send Submissions to the UK MHRA, you must configure and activate the appropriate Gateway Profile by completing the following steps:

In the Admin area, go to the Settings tab.
In the left pane, select Gateway Profiles.
Open the UK MHRA Gateway Profile and 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 your MHRA account exactly matches the URL in this field.
- Sponsor Certificate: Select Choose, and then open the private encryption certificate used to register with the MHRA. 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 the MHRA. This value is the same as the customer’s Routing ID you provided when setting up your production or test MHRA account.
- Health Authority Certificate: Select Choose, and then open the public encryption certificate received from the MHRA during account setup. The public certificate is usually a P7B file.
- Health Authority ID: Enter one of the following EMA identification codes:
  - For a production account, enter MHRAUK.
  - For a test account, enter MHRAUKTEST.
- Health Authority URL: Enter one of the following destination MHRA Gateway URLs:
  - For a production account, enter: https://mft.mhra.gov.uk:443/as2receiver.aspx?Tag=PV
  - For a test account, enter: https://mft-test.mhra.gov.uk:443/as2receiver.aspx?Tag=PV
- 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 UK MHRA Gateway Profile is active and available to use to submit case reports to the MHRA.

Configure the MHRA Transmission Profile

Vault Safety comes with a system-provided MHRA Transmission Profile for electronic Submissions to MHRA.

Manage Transmission Profiles provides instructions on setting up Transmission Profiles.

Complete the following steps to set up the Transmission Profile:

Origin ID: Enter the ID registered with the MHRA, typically your D-U-N-S number. This value is the same as the customer’s Routing ID you provided when setting up your production or test MHRA account.
Destination ID: Enter one of the following Destination IDs:
For a production account, enter MHRAUK.
For a test account, enter MHRAUKTEST.
Routing ID: Enter one of the following Routing IDs:
- For a production account, enter MHRAUK.
- For a test account, enter MHRAUKTEST.

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