# Configure Health Canada AS2 Connection

Set up a Veeva Safety Health Canada <a href="/en/lr/703946/">_AS2 Connection_</a> and _Transmission Profiles_ to support clinical trial and postmarket electronic submissions to Health Canada's Canada Vigilance Program (CVP) through AS2 (system-to-system) communication.

Once the _AS2 Connection_ and _Transmission Profiles_ are configured, you can transmit ICSRs to Health Canada using the <a href="/en/lr/700011/">HC E2B(R2)</a> `.xml` document format on a _Submission_.

<div class="note-border alert-info">
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      <p><strong>Note</strong>: If your Vault currently uses the <a href="/en/lr/01206/">HC <em>Gateway Profile</em></a> to communicate with Health Canada, we recommend that you <a href="#create-as2-connection">create an <em>AS2 Connection</em> to Health Canada</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>
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## Prerequisites

In addition to enabling <a href="/en/lr/01459/">_AS2 Connections_</a>, ensure your Vault has the following configuration for electronic submissions to Health Canada:

* The _Transmission Profile_ with the _API Name_ `hc_cvp__v` should be named **HC MHPD**, with a _Destination ID_ of "MHPDVAL".
* To allow users to manually specify values for the **Message Type (M.1.1)** E2B data element when preparing _Submissions_ to Health Canada, add the **Message Type (HC)** (`message_type_hc__v`) field to the **Submission** layout.
* The Health Canada _Agency_ must be in the **Active** state. Health Canada is a standard _Agency_ provided with Safety. However, in certain Vaults, an Admin must activate the _Agency_ record.

### <a id="activate"></a>Activate the Health Canada Organization

Health Canada comes preconfigured in each Vault as a standard Organization. In certain Vaults, an admin must make the Agency active. Complete the following steps if Health Canada is inactive in your Vault:

1. Go to **Business Admin > Organizations**.
2. Open the **Health Canada** Agency record.
3. Select the **All Actions** menu.
4. Select **Change State to Active**.

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      <p><strong>Note</strong>: The <strong>Change State to Active</strong> user action will only appear if it has been configured in your Vault. <a href="/en/lr/01433/#add-user-action-to-the-organization-lifecycle-inactive-state">Add User Action to the Organization Lifecycle Inactive State</a> provides instructions for this configuration.</p>
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## Configure a Health Canada CVP AS2 Account

Before you can configure the Safety _AS2 Connection_, you must have an active Health Canada CVP AS2 account.

When you configure your account, ensure that the AS2 URL exactly matches the <a href="#as2-vault-url">**AS2 Vault URL** of your _AS2 Connection_</a>.

### Public and Private Certificates

As part of the HC registration process, you must obtain a public and private certificate pair and send the public certificate to  HC.
Your Admin can <a href="/en/lr/872385/#create-sponsor-cert">create these certificates within Vault</a>.


## <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 Health Canada, 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 Health Canada, select <strong>Sync</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 Health Canada, 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>
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      <p><strong>Note</strong>: We do not recommend using any additional ACK stages.</p>
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            </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 Health Canada, 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>
                
                        Enter one of the following Health Canada identification codes:
                        <ul>
                            <li>For a production account, enter <code>HC</code></li>
                            <li>For a test account, enter <code>HCVAL</code></li>
                        </ul>
                    <p>This value cannot include spaces. Instead, use a hyphen (<code>-</code>) or an underscore (<code>_</code>).</p>
                    
            </td>
        </tr>
        <tr>
            <td>
                <em>AS2 Partner URL</em>
            </td>
            <td>
                
                        <p>
                            Enter one (1) of the following destination Health Canada Gateway URLs:
                        </p>
                        <ul>
                            <li>
                                For a production account, enter <code>https://cvp.hc-sc.gc.ca:9442/msgsrv/as2</code>
                            </li>
                            <li>
                                For a test account, enter <code>https://cvp.hc-sc.gc.ca:9443/msgsrv/as2</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 Health Canada. 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> = hc</li>
                    <li><code>&lt;Environment&gt;</code> = validation</li>
                    <li>AS2 Vault URL = <code>https://vernhcvalidation.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://vernhcvalidation.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 Health Canada, 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**.

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      <p><strong>Note</strong>: By default, Vaults are limited to 512 Allowed Connections. If your organization requires more, contact your Veeva Representative.</p>
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### 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.

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      <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>
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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 HC _AS2 Connection_ is active and available to use to submit case reports to Health Canada.

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      <p><strong>Note</strong>: Because Health Canada does not allow testing with third-party vendors, their gateway has not been vendor-tested with Safety. You must perform additional testing when setting up Health Canada electronic submissions.</p>
    </div>
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## Add a Safety Rule Set

Safety comes preconfigured with Health Canada as a standard _Organization_. To define _Case_ criteria for _Submissions_ to the HC CVP Gateway, add a _Safety Rule Set_ to the _Organization_ record by completing the following steps:

1. Navigate to **Business Admin > Objects > Organizations**.
2. On the **Organizations** page, select **Health Canada**.
3. On the **Health Canada** page, select **Edit**.
4. Under **Details**, in the **Submission Rules** field, select a standard _Safety Rule Set_ from the dropdown.
5. Select **Save**.

<div class="note-border alert-info">
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    <div><i class="far fa-info-circle"></i></div>
    <div class="alert-text">
      <p><strong>Note</strong>: <a href="/en/lr/01252/">Standard Reporting Rule Sets</a> provides more information about the available <em>Safety Rule Sets</em>. If you require <em>Safety Rule Sets</em> beyond the standard ones supplied, your Admin can <a href="/en/lr/873466/">create and configure additional rule sets</a>.</p>
    </div>
  </div>
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**Result**

Vault can now auto-generate _Submission_ records for ICSR _Submissions_ to Health Canada based on the _Safety Rule Set_ you selected.

## <a id="configure-the-health-canada-transmission-profile"></a>Configure Health Canada Transmission Profiles

Safety comes with standard, system-provided _Transmission Profiles_ for Health Canada _Submissions_. You must configure these _Transmission Profiles_ as part of the Health Canada Gateway setup.

The following table lists the Vault-provided Health Canada _Transmission Profiles_:

<table class="uk-table uk-table-responsive">
    <thead>
        <tr>
            <th>Transmission Profile</th>
            <th>Usage</th>
        </tr>
    </thead>
    <tbody>
        <tr>
            <td>HC MHPD</td>
            <td>For submitting postmarket reports to Health Canada's Marketed Health Products Directorate (MHPD)</td>
        </tr>
        <tr>
            <td>HC TPD</td>
            <td>For submitting clinical trial reports to Health Canada's Therapeutic Products Directorate (TPD)</td>
        </tr>
    </tbody>
</table>

<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 Health Canada.
* **Destination ID**: Enter the Destination ID for the Health Canada Gateway. You can specify one (1) of the following IDs:

<table>
            <thead>
                <tr>
                    <th>Transmission Profile</th>
                    <th>Supported Destination IDs</th>
                    <th>Description</th>
                </tr>
            </thead>
            <tbody>
                <tr>
                    <td rowspan="2">HC MHPD</td>
                    <td><code>MHPD</code></td>
                    <td>For postmarket reports being sent to the production gateway</td>
                </tr>
                <tr>
                    <td><code>MHPDVAL</code></td>
                    <td>For postmarket reports being sent to the validation gateway</td>
                </tr>
                <tr>
                    <td rowspan="2">HC TPD</td>
                    <td><code>TPD</code></td>
                    <td>For clinical trial reports being sent to the production gateway</td>
                </tr>
                <tr>
                    <td><code>TPDVAL</code></td>
                    <td>For clinical trial reports being sent to the validation gateway</td>
                </tr>
            </tbody>
        </table>

Once you set up the Health Canada _Transmission Profiles_, Vault uses the appropriate _Transmission Profile_ to generate _Submissions_ based on your Vault's <a href="/en/lr/01252/">reporting rules</a> for Health Canada.