# Configure EMA AS2 Connection

Set up an EMA <a href="/en/lr/703946/">_AS2 Connection_</a> and _Transmission Profile_ for users to report cases to EudraVigilance through AS2 (system-to-system) communication.

<div class="note-border alert-info">
  <div class="alert alert-info" role="alert">
    <div><i class="far fa-info-circle"></i></div>
    <div class="alert-text">
      <p><strong>Note</strong>: If your organization is a CRO making <em>Submissions</em> 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.</p>
    </div>
  </div>
</div>




<div class="note-border alert-info">
  <div class="alert alert-info" role="alert">
    <div><i class="far fa-info-circle"></i></div>
    <div class="alert-text">
      <p><strong>Note</strong>: 
If your Vault currently uses the
<a href="/en/lr/01203/">EMA <em>Gateway Profile</em></a>
to communicate with the EMA, we recommend that you
<a href="#create-as2-connection">create an <em>AS2 Connection</em> to the EMA</a>
as described in this article and then follow the instructions in
<a href="/en/lr/01460/">Replace a Gateway Profile with an AS2 Connection</a></p>
    </div>
  </div>
</div>




## Configure a EudraVigilance Account

Before you can configure the Safety EudraVigilance _AS2 Connection_, you must have an active EudraVigilance account. The
<a class="external-link " href="https://www.ema.europa.eu/en/human-regulatory/research-development/pharmacovigilance/eudravigilance/eudravigilance-how-register" target="_blank" rel="noopener">EMA Website<i class="fa fa-external-link" aria-hidden="true"></i></a> provides instructions for registering 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.
Your Admin can <a href="/en/lr/872385/#create-sponsor-cert">create these certificates within Vault</a>.

### 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 <a class="external-link " href="https://www.ema.europa.eu/en/human-regulatory/research-development/pharmacovigilance/eudravigilance/eudravigilance-how-register" target="_blank" rel="noopener">EMA Website<i class="fa fa-external-link" aria-hidden="true"></i></a>.

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

<table>
    <thead>
        <tr>
            <th>Setting</th>
            <th>Description</th>
        </tr>
    </thead>
    <tbody>
        <tr>
            <td>AS2 IP Address</td>
            <td>The AS2 IP address is not required</td>
        </tr>
        <tr>
            <td>AS2 Hostname</td>
            <td>The domain name in the <a href="#as2-vault-url"><strong>AS2 Vault URL</strong> of your <em>AS2 Connection</em></a><br>For example, <code>https://vern-safety.veevavault.com</code>
            </td>
        </tr>
        <tr>
            <td>EMA Receive Port (Vault Transmit Port)</td>
            <td><p>The receive port for the EMA is <code>8080</code>. This is the transmit port that Safety uses when sending outbound <em>Transmissions</em>.</p>
                <p><strong>When submitting the EMA Gateway Connectivity Form, enter this value as the Transmit Port.</strong></p>
            </td>
        </tr>
        <tr>
            <td>EMA Transmit Port (Vault Receive Port)</td>
            <td><p>The transmit port for the EMA is <code>4080</code>. This is the receive port that Safety uses when receiving inbound <em>Transmissions</em>.</p>
                <p><strong>When submitting the EMA Gateway Connectivity Form, enter this value as the Receive Port.</strong></p>
            </td>
        </tr>
        <tr>
            <td>Exchange Point</td>
            <td>The path following <code>:4080</code> in the Vault AS2 URL <br>For example, <code>/api/v1/inbound/transmission</code></td>
        </tr>
        <tr>
            <td>AS2 ID</td>
            <td>The organization ID registered with the EMA</td>
        </tr>
    </tbody>
</table>


## <a id="create-as2-connection"></a> Configure a Safety AS2 Connection

1. Navigate to **Admin > Connections**, then select **Create**.
2. For the **Connection Type**, select **AS2**, then select **Continue**.
3. Complete the applicable <a href="#as2-connection-fields">fields</a>.
4. Select **Save**.

### AS2 Connection Fields {#as2-connection-fields}

With the exception of <a href="#transfer-fields">_Transfer Connection_</a> fields and fields populated by Vault, complete all fields in the following sections:

* <a href="#details-fields">AS2 Details Fields</a>
* <a href="#partner-fields">AS2 Partner Details Fields</a>
* <a href="#sponsor-fields">AS2 Sponsor Details Fields</a>

#### AS2 Details Fields {#details-fields}

<table>
    <thead>
        <tr>
            <th>
                Field
            </th>
            <th>
                Description
            </th>
        </tr>
    </thead>
    <tbody>
        <tr>
            <td>
                <em>Name</em>
            </td>
            <td>
                Enter a name for the <em>AS2 Connection</em>.<br>
                This name must be unique in your Vault.
            </td>
        </tr>
        <tr>
            <td>
                <em>API Name</em>
            </td>
            <td>
                Enter an API Name for the <em>AS2 Connection</em>.<br>
                This name must be unique in your Vault.<br>
            </td>
        </tr>
        <tr>
            <td>
                <em>Description</em>
            </td>
            <td>
                Enter a description for the <em>AS2 Connection</em>.
            </td>
        </tr>
        <tr>
            <td>
                <em>Contact Email</em>
            </td>
            <td>
                Enter the Sender's Email.
            </td>
        </tr>
        <tr>
            <td>
                <em>AS2 Vault Gateway State</em><a id="as2-vault-gateway-state"></a>
            </td>
            <td>
                Vault populates this field with the current state of the AS2 Vault Gateway, which consists of one (1) of the following options:
                <ul>
                    <li>
                        <strong>Unregistered</strong>: The <strong>Sync to Gateway</strong> action has not yet been run for this <em>AS2 Connection</em>.
                    </li>
                    <li>
                        <strong>Registered</strong>: The <em>AS2 Connection</em> is synchronized with the Gateway.
                    </li>
                    <li>
                        <strong>Out of Sync</strong>: Changes have been made to the <em>AS2 Connection</em> or its Connection Allowed List since the last time the <strong>Sync to Gateway</strong> action was run. From the <strong>All Actions</strong> menu, select <strong>Sync To Gateway</strong> to resync the <em>AS2 Connection</em> with the Gateway.
                    </li>
                </ul>
            </td>
        </tr>
        <tr>
            <td>
                <em>AS2 Encryption</em>
            </td>
            <td>
                The algorithm Vault uses to encrypt outbound AS2 messages and decrypt inbound messages.<br>Vault supports the following algorithms:
                <ul>
                    <li>Triple DES (3DES)</li>
                    <li>AES-256-GCM</li>
                    <li>AES-256-CBC</li>
                </ul>
                
                        For the EMA, select <strong>Triple DES (3DES)</strong>.
                    
            </td>
        </tr>
        <tr>
            <td>
                <em>AS2 MDN Setting</em>
            </td>
            <td>
                Whether the Message Delivery Notification (MDN) can be exchanged synchronously (<strong>Sync</strong>) or asynchronously (<strong>Async</strong>).<br>
                
                        For the EMA, select <strong>Async</strong>.
                    
            </td>
        </tr>
        <tr>
            <td>
                <em>AS2 Signature</em>
            </td>
            <td>
                The method Vault uses to sign outbound AS2 messages. Vault supports the following signing methods:
                <ul>
                    <li>SHA-1</li>
                    <li>SHA-256</li>
                </ul>
                
                        For the EMA, select <strong>SHA-256</strong>.
                    
            </td>
        </tr>
        <tr>
            <td>
                <em>AS2 Additional ACK Stages</em>
            </td>
            <td>
                If required, select one (1) or more of the following options:
                <ul>
                    <li>
                        <strong>HTTP Handshake</strong>: Used primarily for asynchronous requests.
                    </li>
                    <li>
                        <strong>PRE-ACK</strong>: Used mainly for FDA VAERS, but can be used with synchronous or asynchronous requests.
                    </li>
                </ul>
                <div class="note-border alert-info">
  <div class="alert alert-info" role="alert">
    <div><i class="far fa-info-circle"></i></div>
    <div class="alert-text">
      <p><strong>Note</strong>: We do not recommend using any additional ACK stages.</p>
    </div>
  </div>
</div>


            </td>
        </tr>
        <tr>
            <td>
                <em>AS2 Partner Sends ACK on MDN URL</em><a id="partner-ack-on-mdn-url"></a>
            </td>
            <td>
                <p>
                    The default setting for this field is <em>No</em>, as Vault expects an AS2 partner to send the ACK using a different URL than that used to send the MDN.
                </p>
                <p>
                
                        Select <strong>No</strong>.
                
                </p>
                <p>
                    For more information about AS2 gateway communications, see <a href="/en/lr/01266/#what-is-as2-gateway-communication">Send a Gateway Transmission</a>.
                </p>
            </td>
        </tr>
        <tr>
            <td>
                <em>AS2 Compression Settings</em><a id="as2-compression-settings"></a>
            </td>
            <td>
                
                        For the EMA, select <strong>Compress After Sign (Standard)</strong>.
                    
            </td>
        </tr>
    </tbody>
</table>

#### AS2 Partner Details Fields {#partner-fields}

<table>
    <thead>
        <tr>
            <th>
                Field
            </th>
            <th>
                Description
            </th>
        </tr>
    </thead>
    <tbody>
        <tr>
            <td>
                <em>AS2 Partner ID</em>
            </td>
            <td>
                
                        <p>
                            Enter one of the following EMA identification codes:
                        </p>
                        <ul>
                            <li>For a production account, enter <code>EVHUMAN</code></li>
                            <li>For a test account, enter <code>EVTEST</code></li>
                        </ul>
                        <p>
                            Whether you are submitting <em>Study</em> or postmarket <em>Cases</em>, enter one (1) of these values. This value cannot include spaces. Instead, use a hyphen (<code>-</code>) or an underscore (<code>_</code>). You can specify the destination gateway endpoint in the <em>Transmission Profile</em>.
                        </p>
                    
            </td>
        </tr>
        <tr>
            <td>
                <em>AS2 Partner URL</em>
            </td>
            <td>
                
                        <p>
                            Enter one (1) of the following destination EudraVigilance Gateway URLs:
                        </p>
                        <ul>
                            <li>
                                For a production account, enter <code>http://pgateway.ema.europa.eu:8080/exchange/EVHUMAN</code>
                            </li>
                            <li>
                                For a test account, enter <code>http://vgateway.ema.europa.eu:8080/exchange/EVTEST</code>
                            </li>
                        </ul>
                    
            </td>
        </tr>
        <tr>
            <td>
                <em>AS2 Partner Certificate Expiry</em>
            </td>
            <td>
                Vault populates this field when your Admin <a
                href="#upload-certificates">uploads the partner certificate</a>.
            </td>
        </tr>
        <tr>
            <td>
                <em>AS2 Partner Certificate Serial Number</em>
            </td>
            <td>
                When you upload a new partner certificate for this connection, Vault sets this field to the Serial Number of the certificate in decimal format.
            </td>
        </tr>
    </tbody>
</table>

#### AS2 Sponsor Details Fields {#sponsor-fields}

<table>
    <thead>
        <tr>
            <th>
                Field
            </th>
            <th>
                Description
            </th>
        </tr>
    </thead>
    <tbody>
        <tr>
            <td>
                <em>AS2 Vault ID</em>
            </td>
            <td>
                
                      Enter the sponsor ID registered with EudraVigilance. This value cannot include spaces. Instead, use a hyphen (<code>-</code>) or an underscore (<code>_</code>).
                    
            </td>
        </tr>
        <tr>
            <td>
                <a id="as2-vault-url"></a>
                <em>AS2 Vault URL</em>
            </td>
            <td>
                
                <p>
                    Enter the AS2 URL of your Vault in the following format, replacing <code>&lt;SponsorName&gt;&lt;Partner&gt;&lt;Environment&gt;</code> with the corresponding values of your Vault:
                </p>
                <p>
                    <code>https://&lt;SponsorName&gt;&lt;Partner&gt;&lt;Environment&gt;.gateway.veevavaultsafety.com:4080</code>
                </p>
                <p>
                    The following example demonstrates how to form the AS2 Vault URL for a Vault with the following values:
                </p>
                <ul>
                    <li><code>&lt;SponsorName&gt;</code> = vern</li>
                    <li><code>&lt;Partner&gt;</code> = ema</li>
                    <li><code>&lt;Environment&gt;</code> = validation</li>
                    <li>AS2 Vault URL = <code>https://vernemavalidation.gateway.veevavaultsafety.com:4080</code></li>
                </ul>
                <p>
                    <strong>Informing the Partner of your AS2 Vault URL</strong>
                </p>
                <p>
                    When informing the partner of the URL they need to use for this <em>AS2 Connection</em>, use the value you entered in this field appended with <code>/api/v1/inbound/transmission</code>
                </p>
                <p>
                    In the example shown above, this is <code>https://vernemavalidation.gateway.veevavaultsafety.com:4080/api/v1/inbound/transmission</code>
                </p>
                
            </td>
        </tr>
        <tr>
            <td>
                <em>AS2 Vault Certificate Expiry</em>
            </td>
            <td>
                Vault populates this field when your Admin <a
                href="#upload-certificates">uploads the sponsor certificate</a>.
            </td>
        </tr>
        <tr>
            <td>
                <em>AS2 Vault Certificate Serial Number</em>
            </td>
            <td>
                When you upload a new sponsor certificate for this connection, Vault sets this field to the Serial Number of the certificate.
            </td>
        </tr>
        <tr>
            <td>
                <a id="as2-vault-domain-ip-config"></a>
                <em>AS2 Vault Domain / IP Configuration</em>
            </td>
            <td>
                <p>
                    Select the method the partner uses to interface with the <em>AS2 Connection</em>.
                </p>
                <ul>
                    <li><strong>AS2 Vault URL: Domain Name (typical)</strong>: A standard domain name that resolves to dynamic IP addresses.</li>
                    <li><strong>AS2 Vault URL: Domain Name bound to static IP addresses</strong>: A standard domain name that resolves to static IP addresses.</li>
                    <li><strong>AS2 Vault URL: IP URL (uncommon)</strong>: A non-standard IP address domain name that resolves to an IP address.</li>
                </ul>
                
                      For the EMA, select <strong>AS2 Vault URL: Domain Name (typical)</strong>.
                    
            </td>
        </tr>
    </tbody>
</table>

#### Transfer Connection Fields {#transfer-fields}

Leave the fields in this section blank.


### Upload the Partner and Sponsor Certificates {#upload-certificates}

Safety uses
<a href="/en/lr/872385/">partner and sponsor certificates</a>
to communicate securely with the partner. You will have received the partner certificate as part of creating your account with the partner.

Complete the following steps to create and upload these certificates:
* <a href="/en/lr/872385/#upload-partner-cert">Upload the partner certificate for the connection</a>.
* <a href="/en/lr/872385/#create-sponsor-cert">Create a sponsor certificate for the connection</a>.

### 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_.

Perform the following steps for each Allowed Connection you want to add to the _AS2 Connection_:

1. Navigate to **Admin > Connections > [Connection] > Connection Allowed Lists**, then select **Create**.
2. 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.
3. Repeat the above steps for each Allowed Connection.
4. When you have added all the Allowed Connections, select **Save**.

<div class="note-border alert-info">
  <div class="alert alert-info" role="alert">
    <div><i class="far fa-info-circle"></i></div>
    <div class="alert-text">
      <p><strong>Note</strong>: By default, Vaults are limited to 512 Allowed Connections. If your organization requires more, contact your Veeva Representative.</p>
    </div>
  </div>
</div>



### Synchronize the Connection {#sync-as2-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](#as2-vault-gateway-state) changes to **Registered** and Vault can send and receive messages using this Connection.

<div class="note-border alert-info">
  <div class="alert alert-info" role="alert">
    <div><i class="far fa-info-circle"></i></div>
    <div class="alert-text">
      <p><strong>Note</strong>: If the <em>Sync Connection to Gateway</em> action is not successful, ensure each field value on the <em>AS2 Connection</em> is correct before retrying the action again. If the issue persists, <a href="/en/lr/728014/">troubleshoot the connection</a>.</p>
    </div>
  </div>
</div>



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 EMA _AS2 Connection_ is active and available to use to submit case reports to the EMA.


## Configure EMA Transmission Profiles {#configure-an-ema-transmission-profile}

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 Vault-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)|

<a href="/en/lr/01202/">Manage Transmission Profiles</a> 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_, Vault uses the appropriate _Transmission Profile_ to generate _Submissions_ based on your Vault's EMA <a href="/en/lr/01252/">reporting rules</a>.

[1]: #configure-an-ema-transmission-profile