Configure EMA AS2 Connection

Set up an EMA AS2 Connection and Transmission Profile to support submissions through EudraVigilance.

About AS2 Connection Support for the EudraVigilance Gateway

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.

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

Configure a EudraVigilance Account

Before you can configure the Vault Safety EudraVigilance AS2 Connection, you must have an active EudraVigilance account. The EMA Website provides instructions for registering with EudraVigilance.

Public and Private Certificates

As part of the EMA registration process, you must send a public and private certificate pair 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 AS2 Connection settings in your Vault.

Complete the EMA Connectivity Form

Once you have the AS2 Connection settings 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 the AS2 Vault URL of your AS2 Connection 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, enter this value 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, enter this value as the Receive Port.
Exchange Point	The path following `:4080` in the Vault AS2 URL For example, `/api/v1/inbound/transmission/`
AS2 ID	The organization ID registered with the EMA

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

Fields marked with a (*) are required.

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	The system populates this field with the current state of the AS2 Vault Gateway, which consists of one of the following options: 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 Encryption	The algorithm the system uses to encrypt outbound AS2 messages and decrypt inbound messages. The system supports the following algorithms: Triple DES (3DES) AES-256-GCM AES-256-CBC For the EMA, select Triple DES (3DES).
AS2 MDN Setting	Whether the Message Delivery Notification (MDN) can be exchanged synchronously (Sync) or asynchronously (Async). For the EMA, select Async.
AS2 Signature	The method the system uses to sign outbound AS2 messages. The system supports the following signing methods: SHA-1 SHA-256 For the EMA, select SHA-256.
AS2 Compress Before Sign	If this option is selected, the system compresses messages before applying the Signing Algorithm. If this option is not selected, the system compresses messages after applying the Signing Algorithm. Note: We recommend leaving this option unselected.
AS2 Additional ACK Stages	If required, select one 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 Partner 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 postmarket Cases, enter one of these values. You can specify the destination gateway endpoint in the Transmission Profile.
AS2 Partner 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`.
AS2 Partner Certificate Expiry	The system automatically populates this field when an Admin uploads the Partner Certificate.
AS2 Vault ID	Enter the sponsor ID registered with EudraVigilance.
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/api/v1/inbound/transmission/` The following example demonstrates how to form the AS2 Vault URL for a Vault with the following values: `<SponsorName>` = vern `<Partner>` = ema `<Environment>` = validation AS2 Vault URL = `https://vernemavalidation.gateway.veevavaultsafety.com:4080/api/v1/inbound/transmission/`
AS2 Vault Certificate Expiry	The system automatically populates this field when an Admin uploads the Sponsor Certificate.

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

Partner certificate: 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 Veeva Managed Services.

Upload Partner Certificate

From the All Actions menu, select Upload Partner Certificate.
Select Choose, then select the Partner’s Public Certificate.
Accepted formats: PKCS7 (.p7b or .p7c), DER (.cer or .der) and 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.

From the All Actions menu, select Upload Sponsor Certificate.
Select Choose, then select the Sponsor’s Public Certificate.
Accepted formats: 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 the system will allow to connect with this AS2 Connection.

Note: To obtain the latest list of allowed connections for the EMA, contact Veeva Managed Services.

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

Go to the Connection Allowed Lists section, then select Create.
Enter the Name, (optional) Description, and IP 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 steps 1 and 2 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 Veeva Managed Services.

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

Note: If the Sync Connection to Gateway action is not successful, ensure the value of each of the AS2 Connection fields is correct before retrying the action again. If the issue perists, contact Veeva Managed Services.

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. The system cannot send or receive any messages using this Connection while it is in the 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 EMA AS2 Connection 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.
- For 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.