Sections in This Article
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 Connection 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 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 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 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.
Manage Users provides more information on setting up user contact details.
Your Admin 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 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. |
| Description | Enter a description for the AS2 Connection. |
| Contact Email* | Enter the Sender’s Email |
| AS2 Additional ACK Stages |
Select from the following options:
|
| AS2 Compress Before Sign |
Select Yes if the system should compress messages before applying the Signing Algorithm.
Select No if the system should compress messages after applying the Signing Algorithm. |
| AS2 Encryption |
Select the algorithm the system uses to encrypt outbound AS2 messages and decrypt inbound messages. The system supports the following algorithms:
|
| AS2 MDN Setting | Select whether the Message Delivery Notification (MDN) can be exchanged synchronously (Sync) or asynchronously (Async). |
| AS2 Partner Certificate Expiry | The system automatically populates this field when an Admin uploads the Partner Certificate. |
| AS2 Partner ID |
Enter one of the following FDA identification codes:
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:
|
| AS2 Signature |
Select the method the system uses to sign outbound AS2 messages. The system supports the following signing methods:
|
| AS2 Vault Certificate Expiry | The system automatically populates this field when an Admin uploads the Sponsor Certificate. |
| AS2 Vault Gateway State |
The system populates this field with the current state of the AS2 Vault Gateway.
|
| AS2 Vault ID | Enter the sponsor ID registered with EudraVigilance. |
| AS2 Vault URL | This field is read-only. Verify that the DNS configured in the EudraVigilance account exactly matches the URL in this field. |
Upload the Partner and Sponsor Certificates
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 (.p7bor.p7c), DER (.ceror.der) and PEM (.cer,.crt, or.pem)
Note: Vault checks the expiry date of the certificate. If the certificate is no longer valid, you cannot save the record. - Select Continue.
Upload Sponsor Certificate
- From the All Actions menu, select Upload Sponsor Certificate.
- Select Choose, then select the Sponsor’s Public Certificate.
Accepted formats: PKCS12 (.pfxor.p12)
Note: Vault will check the expiry date of the certificate. If the certificate is no longer valid, you cannot save the record. - Select Continue.
Add Allowed Connections
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. 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 isXX.XX.XX.XXorXX.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.
- For a production EVCTM account, enter
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.
