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How to use the Common Electronic Submissions Gateway to send regulatory transactions to Health Canada

In order to begin using the Common Electronic Submissions Gateway (CESG) each sponsor must first complete the following steps:

Step 1: Register as a Trading Partner with Food & Drug Administration (FDA)

  • Complete the FDA Electronic Submissions Gateway (ESG) registration for a WebTrader or AS2 account in order to be able to send your regulatory transaction.
  • For more information on how to register as a Trading Partner with the FDA please see the FDA User Guide.

Step 2: Send regulatory transactions to Health Canada via the CESG

  • Send regulatory transactions to the FDA ESG and ensure that "HC" is selected as the centre.
  • Regulatory transactions intended for Health Canada will be automatically redirected.
  • For more information on how to submit regulatory transactions please see the FDA User Guide.
  • Contact us for any questions or technical difficulties. Please refer to Inquiries and Support for details on where to direct your questions.

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2024-05-23

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