2014/01/24 Common Electronic Submissions Gateway (CESG) to send regulatory transactions to Health Canada

 

The Common Electronic Submissions Gateway (CESG) is a method of securely providing regulatory transactions for review in the electronic Common Technical Document (eCTD) format.

 

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

 

In order to begin using the 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 (available below)

 

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
  • Contact Health Canada for any questions or technical difficulties. Please refer to Inquiries and Support for details on where to direct your questions.

 Health Canada, available at: http://www.hc-sc.gc.ca/dhp-mps/prodpharma/applic-demande/guide-ld/cesg-pcde/inst-eng.php

 


The FDA user guide can be found here:

 

FDA Electronic submission Gateway User Guide

 

The Health Canada Inquires and support address can be found here:

 

Inquiries and Support address Health Canada

 

E-mail this page   Printable version of this page
Developed by Interactive Studios