Configure Health Canada AS2 Connection

Set up a Vault Safety Health Canada AS2 Connection and Transmission Profiles to support clinical trial and postmarket electronic submissions to Health Canada.

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Note Beginning with 24R1 in April 2024 and for all subsequent releases, the new Vault Safety Help site is the official site for all Vault Safety Help content. This site reflects updates until the 23R3 release only. For the latest information, visit the new site.

About AS2 Connection Support for the Health Canada Gateway

Vault Safety supports electronic submissions to Health Canada (HC) through AS2 (system-to-system) communication. Vault Safety supports clinical trial and postmarket electronic submissions to Health Canada’s Canada Vigilance Program (CVP).

Note Contact Veeva Managed Services for guidance on best practices before configuring the HC CVP AS2 Connection.

Once the AS2 Connection and Transmission Profiles are configured, you can transmit ICSRs to Health Canada using the HC E2B(R2) .xml document format on a Submission.

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

Prerequisites

Ensure your Vault has the following configuration before you configure 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 page layout.
  • The Health Canada Agency must be in the Active state.
    Health Canada is a standard Agency provided with Vault Safety. However, in certain Vaults, an Admin must activate the Agency record.
    • Read More...

      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.

      Note The Change State to Active user action will only appear if it has been configured in your Vault. Add User Action to the Organization Lifecycle provides instructions for this configuration.

Configure a Health Canada CVP AS2 Account

Before you can configure the Vault Safety Gateway Profile, you must have an active Health Canada CVP AS2 account.

As part of the registration process, you must send a public and private certificate pair to Health Canada. If you need help generating these certificates, contact Veeva Managed Services.

When you configure your account, ensure that the AS2 URL exactly matches the AS2 Vault URL of your AS2 Connection.

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 Health Canada 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

  1. Go to Admin > Connections, then select Create.
  2. For the Connection Type, select AS2, then select Continue.
  3. Complete the AS2 Connection Fields.
  4. 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:
  • HTTP Handshake: Used primarily for asynchronous requests.
  • PRE-ACK: Used mainly for FDA VAERS, but can be used with synchronous or asynchronous requests.
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:
  • Triple DES (3DES)
  • AES-256-GCM
  • AES-256-CBC
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 the appropriate Health Canada identification code.
AS2 Partner URL Enter the destination Health Canada Gateway URL.
AS2 Signature Select the method the system uses to sign outbound AS2 messages. The system supports the following signing methods:
  • SHA-1
  • SHA-256
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.
  • 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 list, select Sync To Gateway to resync the AS2 Connection with the Gateway.
AS2 Vault ID Enter the sponsor ID registered with Health Canada.
AS2 Vault URL This field is read-only. Verify that the DNS configured in the Health Canada 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

  1. From the All Actions menu, select Upload Partner Certificate.
  2. 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)
    Note: Vault checks the expiry date of the certificate. If the certificate is no longer valid, you cannot save the record.
  3. Select Continue.

Upload Sponsor Certificate

  1. From the All Actions menu, select Upload Sponsor Certificate.
  2. Select Choose, then select the Sponsor’s Public Certificate.
    Accepted formats: PKCS12 (.pfx or .p12)
    Note: Vault will check the expiry date of the certificate. If the certificate is no longer valid, you cannot save the record.
  3. 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.

  1. Go to the Connection Allowed Lists section, then select Create.
  2. 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.
  3. Repeat steps 1 and 2 for each Allowed Connection.
  4. 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 HC AS2 Connection is active and available to use to submit case reports to Health Canada.

Note Because Health Canada does not allow testing with third-party vendors, their gateway has not been vendor-tested with Vault Safety. You must perform additional testing when setting up Health Canada electronic submissions. Contact Veeva Managed Services for assistance.

Add a Submission Rule Set

Vault Safety comes preconfigured with Health Canada as a standard Organization. To define Case criteria for Submissions to the HC CVP Gateway, you need to add a Submission Rule Set to the Organization record by completing the following steps:

  1. Go 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 Rule Set from the picklist.

    Note Reporting Rule Sets provides more information about the available Rule Sets. If these do not fulfill your requirements and you need a different Rule Set, contact your Veeva Managed Services representative.

  5. Select Save.

Result

The system can now auto-generate Submission records for ICSR Submissions to Health Canada based on the Rule Set you selected.

Configure Health Canada Transmission Profiles

Vault 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 system-provided Health Canada Transmission Profiles:

Transmission Profile Usage
HC MHPD For submitting postmarket reports to Health Canada’s Marketed Health Products Directorate (MHPD)
HC TPD For submitting clinical trial reports to Health Canada's Therapeutic Products Directorate (TPD)

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 Health Canada.
  • Destination ID: Enter the Destination ID for the Health Canada Gateway. You can specify one (1) of the following IDs:
    Transmission Profile Supported Destination IDs Description
    HC MHPD MHPD For postmarket reports being sent to the production gateway
    MHPDVAL For postmarket reports being sent to the validation gateway
    HC TPD TPD For clinical trial reports being sent to the production gateway
    TPDVAL For clinical trial reports being sent to the validation gateway

Once you set up the Health Canada Transmission Profiles, the system uses the appropriate Transmission Profile to generate Submissions based on your Vault’s reporting rules for Health Canada.

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