Configure MHRA AS2 Connection

Set up a Vault Safety UK MHRA AS2 Connection to support submissions through the MHRA Gateway.

About AS2 Connection Support for the MHRA Gateway

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.

Note: If your Vault currently uses the MHRA Gateway Profile to communicate with the MHRA, we recommend that you create an AS2 Connection to the MHRA as described in this article and then follow the instructions in Replace a Gateway Profile with an AS2 Connection.

Prerequisite

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 is a standard Agency provided with Vault Safety. However, in certain Vaults, your Admin must activate the Agency record.

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

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

Note: The Change State to Active user action appears only if configured by your Admin. Enable Regulatory Agencies as Standard Organizations provides instructions.

Prerequisite: Update Country Records

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

To ensure all new Cases reference the correct Country and Agency, we recommend updating 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:

Step One: Update Existing Country Record to the United Kingdom (Great Britain) Record
Step Two: Create the United Kingdom (Northern Ireland) Record

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

Go to Business Admin > Objects > Countries.
Select United Kingdom of Great Britain and Northern Ireland. 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. Due to an overlap in Code (3-letter) values, creating a new record with the same code will cause E2B imports to fail.

Step Two: 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 (2) 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 for setting 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.

Configure a Vault Safety AS2 Connection

Go to Admin > Connections, then select Create.
For the Connection Type, select AS2, then select Continue.
Complete the AS2 Connection Fields.
Select Save.

AS2 Connection Fields

Field	Description
Name	Enter a name for the AS2 Connection. This name must be unique in your Vault.
API Name	Enter an API Name for the AS2 Connection. This name must be unique in your Vault.
Contact Email	Enter the Sender's Email.
Description	Enter a description for the AS2 Connection.
AS2 Vault Gateway State	Vault populates this field with the current state of the AS2 Vault Gateway, which consists of one (1) of the following options: Unregistered: The Sync to Gateway action has not yet been run for this AS2 Connection. Registered: The AS2 Connection is synchronized with the Gateway. Out of Sync: Changes have been made to the AS2 Connection or its Connection Allowed List since the last time the Sync to Gateway action was run. From the All Actions menu, select Sync To Gateway to resync the AS2 Connection with the Gateway.
AS2 Additional ACK Stages	If required, select one (1) or more of the following options: HTTP Handshake: Used primarily for asynchronous requests. PRE-ACK: Used mainly for FDA VAERS, but can be used with synchronous or asynchronous requests. Note: We do not recommend using any additional ACK stages.
AS2 Encryption	The algorithm Vault uses to encrypt outbound AS2 messages and decrypt inbound messages. Vault supports the following algorithms: Triple DES (3DES) AES-256-GCM AES-256-CBC For the MHRA, select Triple DES (3DES).
AS2 MDN Setting	Whether the Message Delivery Notification (MDN) can be exchanged synchronously (Sync) or asynchronously (Async). For the MHRA, select Async.
AS2 Signature	The method Vault uses to sign outbound AS2 messages. Vault supports the following signing methods: SHA-1 SHA-256 For the MHRA, select SHA-256.
AS2 Compress Before Sign	If you select this option, Vault compresses messages before applying the Signing Algorithm. If you do not select this option, Vault compresses messages after applying the Signing Algorithm. Note: We recommend leaving this option unselected.
AS2 Partner ID	Enter one of the following MHRA identification codes: For a production account, enter `MHRAUK`. For a test account, enter `MHRAUKTEST`.
AS2 Partner URL	Enter one (1) of the following destination MHRA Gateway URLs: For a production account, enter `https://mft1.mhra.gov.uk/as2receiver.aspx?Tag=PV` For a test account, enter `https://mft-test.mhra.gov.uk:443/as2receiver.aspx?Tag=PV`
AS2 Partner Certificate Expiry	Vault automatically populates this field when your Admin uploads the Partner Certificate.
AS2 Vault 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.
AS2 Vault URL	Enter the AS2 URL of your Vault in the following format, replacing `<SponsorName><Partner><Environment>` with the corresponding values of your Vault: `https://<SponsorName><Partner><Environment>.gateway.veevavaultsafety.com:4080` The following example demonstrates how to form the AS2 Vault URL for a Vault with the following values: `<SponsorName>` = vern `<Partner>` = mhra `<Environment>` = validation AS2 Vault URL = `https://vernmhravalidation.gateway.veevavaultsafety.com:4080` Informing the Partner of your AS2 Vault URL When informing the Partner of the URL they need to use for this AS2 connection, use the value you entered in this field appended with `/api/v1/inbound/transmission/`. In the example shown above, this is `https://vernmhravalidation.gateway.veevavaultsafety.com:4080/api/v1/inbound/transmission/`.
AS2 Vault Certificate Expiry	Vault automatically populates this field when your Admin uploads the Sponsor Certificate.
AS2 Vault Domain / IP Configuration	Select the method the Partner uses to interface with the AS2 Connection. AS2 Vault URL: Domain Name (typical): A standard domain name that resolves to dynamic IP addresses. AS2 Vault URL: Domain Name bound to static IP addresses: A standard domain name that resolves to static IP addresses. AS2 Vault URL: IP URL (uncommon): A non-standard IP address domain name that resolves to an IP address. For the MHRA, select AS2 Vault URL: Domain Name (typical).
AS2 Ingress IPs	If you set the AS2 Vault Domain / IP Configuration field to AS2 Vault URL: Domain Name bound to static IP addresses, Vault populates this field automatically.

Vault Safety uses the Partner and Sponsor certificates to communicate securely with the Partner.

You will have received the Partner certificate as part of creating your account with the Partner.

If you need help generating a Sponsor certificate, contact your Veeva Representative.

Upload Partner Certificate

Go to Admin > Connections > [Connection].
From the All Actions menu, select Upload Partner Certificate.
Select Choose, then select the Partner’s Public Certificate.
The following accepted formats are:
- PKCS7 (.p7b or .p7c)
- DER (.cer or .der)
- PEM (.cer, .crt, or .pem)
  Vault checks the expiry date of the certificate. If the certificate is no longer valid, you cannot save the record.
Select Continue.

Go to Admin > Connections > [Connection].
From the All Actions menu, select Upload Sponsor Certificate.
Select Choose, then select the Sponsor’s Public Certificate.
The accepted formats are PKCS12 (.pfx or .p12)
Vault checks the expiry date of the certificate. If the certificate is no longer valid, you cannot save the record.
Select Continue.

Add Connection Allowed IPs

Specify one (1) or more Allowed Connections for the AS2 Connection. These are Internet Protocol (IP) addresses that Vault will allow to connect with this AS2 Connection.

Note: To obtain the latest list of allowed connections for the MHRA, contact your Veeva Representative.

Perform the following steps for each Allowed Connection you want to add to the AS2 Connection:

Go to Admin > Connections > [Connection].
Go to the Connection Allowed Lists section, then select Create.
On the Create Connection Allowed List window, complete the following information:
- Name: Enter a name for the Allowed Connection.
- (Optional) Description: Enter a description for the Allowed Connection.
- IP: Enter the address of the Allowed Connection.
  Ensure the format of the IP address is XX.XX.XX.XX or XX.XX.XX.XX/{subnet mask} where the {subnet mask} is a number between 24 and 32.
Repeat the above steps for each Allowed Connection.
When you have added all the Allowed Connections, select Save.

Note: By default, Vaults are limited to 512 Allowed Connections. If your organization requires more, contact your Veeva Representative.

Synchronize the Connection

Once you have entered all the details of the AS2 Connection, the Connection must be synchronized with the Gateway.

From the All Actions menu, select Sync Connection to Gateway.

When Vault successfully completes this action, the Connection’s AS2 Vault Gateway State changes to Registered and Vault can send and receive messages using this Connection.

Note: If the Sync Connection to Gateway action is not successful, ensure each field value on the AS2 Connection is correct before retrying the action again. If the issue persists, contact your Veeva Representative.

If you make any changes to the Connection object or its Connection Allowed List, the AS2 Vault Gateway State changes to Registered - Out of Sync. Vault cannot send or receive any messages using this Connection while it is in the Registered - Out of Sync state. You will need to repeat the All Actions > Sync to Gateway action to restore the Connection to the Registered state.

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. You must configure this Transmission Profile as part of the MHRA Gateway setup.

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 (1) 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, Vault uses the appropriate Transmission Profile to generate Submissions based on your Vault’s MHRA reporting rules.