Frequently Asked Questions - Common Electronic Submissions Gateway

1. How does the Common Electronic Submissions Gateway (CESG) work?
(Updated 2016-07-11)

The CESG allows Trading Partners provide regulatory transactions to Health Canada electronically, i.e. an "electronic" courier. The CESG is a service of convenience and is an optional method of providing regulatory transactions, taking the place of traditional courier methods and/or submitting on CD/DVD.

See Figure 1 for an illustration of the CESG High Level Architecture:

Figure 1: Common Electronic Submissions Gateway (CESG) High Level Architecture

The Trading Partner (TP) requests a digital certificate from the Certificate Authority (CA). The CA assigns a digital certificate to the TP.

The TP transmits a regulatory transaction. It is first received by the Food & Drug Administration (FDA) portion of the gateway. The TP receives two FDA Acknowledgements once the transmission is complete.

After passing through a firewall, the regulatory transaction is then routed to the inbox of the Health Canada portion of the gateway. The regulatory transaction routed to the Storage Area Network in the Health Canada Viewing Tool.

An Acknowledgement Receipt is created and sent to the outbox. This Acknowledgement Receipt is then routed back through the Health Canada and FDA portions of the gateway and sent to the Trading Partner. A MDN is also sent to the FDA Gateway confirming that the Health Canada received the regulatory transaction.

The regulatory transaction then undergoes Validation and Import. If it fails validation, the regulatory transaction is placed in the Failed Validation folder. If it fails Import, the regulatory transaction is placed in the Failed Import folder. After a successful Import, the regulatory transaction is stored in the eSub portion of the Storage Area Network.

2. How do I become a Trading Partner to use the CESG?

Please refer to the Food and Drug Administration (FDA)  User guide for registration process information.

3. I am already registered as a Trading Partner with the Food and Drug Administration (FDA), do I need a Health Canada specific account?

If you are already registered with the FDA as a Trading Partner and now wish to do business with Health Canada via the CESG, you do not need to create a new account. You can use your existing account and simply select "HC" as the Review Centre

4. What do the Various Notifications being received by the CESG mean?

When using the CESG to submit to the "HC" Centre, you will receive three messages. The first message Message Disposition Notifications (MDN) will be issued by the FDA, indicating that the FDA portion of the gateway has successfully received your regulatory transaction and will include your Message ID. The second message is a new ACK from the FDA which contains the Message ID and Core ID. The third message (Health Canada Acknowledgement Receipt see figure 4) will be issued by Health Canada, indicating that your regulatory transaction has been successfully received by Health Canada portion of the gateway and contains the Core ID.

Please note: The order of which the acknowledgments are displayed may not reflect the order they are received. You will be required to double click on the ACK to see the receipt time of each ACK. This is a known issue that is slated for correction in early 2017.

Figure 2 illustrates how the notification of the MDN, FDA and Health Canada Acknowledgment receipts appear in the Inbox of the WebTrader:

Figure 2: MDN and Health Canada Acknowledgement Receipt

Description: Illustrates how the Message Disposition Notification (MDN), FDA Acknowledgement and Health Canada Acknowledgment Receipt appear in the Inbox of the WebTrader. The MDN (FDA receipt) is shown first with the FDA and HC Acknowledgement below.

Figure 3 illustrates the new ACK from the FDA which includes the MessageID and CoreID

Figure 3: FDA ACK

Description: Image of the FDA Acknowledgement Receipt which includes the Message ID, Core ID and Date & Time stamp.

5. Where can I find the time stamp that Health Canada received the regulatory transaction?
(Update 2016-07-11)

The time stamp that Health Canada uses as the receipt date/time can be found in the Health Canada Acknowledgement Receipt and is highlighted in Figure 4:

Figure 4: Health Canada Acknowledgement Receipt

Description: Image of the Health Canada Acknowledgement Receipt with the Date stamp highlighted. In this example the Date & Time that is highlighted is 12202013094914, which can be read as December 20, 2013 at 09:49:14 AM.

The time stamp "12122013094914" can be read as "Month/Day/Year/Hour/Minute/Second" or "December 12, 2013 at 09:49:14 AM".

6. How are transactions received after end of business, on the weekend, or on a Statutory Holiday handled by Health Canada?

These transactions are handled in a manner that is consistent with current practices. Any regulatory transaction received after 5:00 pm Eastern Standard Time, on a weekend, or on a Statutory Holiday is considered received on the next Health Canada business day.

7. What format of regulatory transactions can be sent via CESG?

At this time Health Canada is only accepting regulatory transactions in eCTD format via CESG.

8. What types of regulatory transactions can be sent via CESG?

(Updated  2016-12-22)

All regulatory activities and transactions in eCTD format as per the scope of Guidance Document - Preparation of Drug Regulatory Activities in the Electronic Common Technical Document Format are accepted via the CESG including the first transactions.

In addition, the transactions related to Drug Master Files in eCTD format are also accepted as per the Notice - Re: Preparation of Drug Master File (DMF) in "Non-eCTD Electronic-Only" Format on the Health Canada website.

9. Can I send Post-Notice of Compliance (NOC) Changes: Level III via CESG?

Yes.

10. What folder structure should be used when sending regulatory transactions via CESG?
(Updated 2016-07-11)

Health Canada requires that the Trading Partner includes the top level folder when sending the eCTD sequence via CESG. For an illustration of the acceptable folder structure, see Figure 5.

Figure 5: Folder Structure

Description: Illustrates the acceptable folder structure for sending regulatory transactions via CESG including the Top Level Folder and Sequence Number Folder. In this example the Top Level Folder is e123456 and the Sequence Number Folder is 0000.

11. Can the revised sequence for an eCTD sequence that failed validation be resent via CESG?

Health Canada will accept the revised eCTD sequence that failed validation only for regulatory transaction types listed in FAQs # 8 and 9.

12. What should be done if the Health Canada Acknowledgement Receipt is not received?

The Trading Partner should notify Health Canada via email at hc_cesg_pcde_sc@hc-sc.gc.ca

13. What should be done if the Health Canada Acknowledgement Receipt is received with missing information?

The Trading Partner should provide the Acknowledgment to Health Canada via email at hc_cesg_pcde_sc@hc-sc.gc.ca.

14. If the Health Canada Acknowledgement Receipt was not received should the eCTD sequence be resent?

Please do not resend an eCTD sequence if the Health Canada Acknowledgement is not received right away. Depending on the file size, it may take one hour or more to receive an Acknowledgement Receipt. Trading Partners should not resend eCTD sequences unless it is requested by Health Canada. If you would like to confirm whether your sequence has been received, please contact hc_cesg_pcde_sc@hc-sc.gc.ca.

15. Are electronic Signatures (e-Signatures) accepted by the Health Products and Food Branch (HPFB) and can they be used when submitting to the CESG?

Yes, e-signatures are accepted at HPFB in accordance with the Health Products and Food Branch Electronic Signatures Policy. They are coordinated with the directorates and handled on a case-by-case basis. The Policy, which was co-authored with industry, is provided upon request by emailing hc_cesg_pcde_sc@hc-sc.gc.ca.

16. What are some of the CESG terminology differences between the FDA and Health Canada?

When using the CESG you will notice differences in the terminology used by the FDA and Health Canada. Table 1 provides a comparison of similar terms used by FDA and Health Canada.

Table 1: Comparison of Similar Terms used by FDA and Health Canada
FDA Term Health Canada Term
FDA ESG (FDA Electronic Submissions Gateway) CESG (Common Electronic Submissions Gateway)
Transaction Partner Trading Partner
Submissions Regulatory Transaction

Please note that, in some cases, these terms may be used interchangeably when corresponding with Health Canada and/or the FDA.

17. Who do I contact for more information on the Common Electronic Submissions Gateway (CESG)?

Please refer to Inquiries and Support for details on where to direct your questions.

18. Is it acceptable that the second language Product Monograph be sent via CESG exclusively?

Yes, the second language product monograph can be sent exclusively via CESG. There is no need to provide the second language product monograph separately via email to SIPD-DIN@HC-SC.GC.CA. Health Canada will internally route this transaction to the appropriate bureau.

19. Is it acceptable that the Drug Notification Form be sent via CESG exclusively?
(Updated 2016-02-09)

Yes, the Drug Notification Form (DNF) can be sent exclusively via CESG. When provided via the CESG, a duplicate copy of the DNF must not be sent via email. Health Canada will internally route this transaction to the appropriate bureau.

20. If the eCTD sequence (regulatory transaction) was sent via CESG, should the same eCTD transaction also be sent on a CD with printed copy of the cover letter via courier?

No, If the regulatory transaction was sent via CESG, no additional copies of the same transaction should be sent on CD via courier.

21. What is the maximum allowed path length, including the file name, for regulatory transactions sent via CESG?

The maximum allowed path length in transactions sent via CESG is 180 characters.

22. How to pay fees for submissions sent via the CESG?
(New question 2016-02-09)

The information listed for the payment methods below should be included in the cover letter provided as part of the regulatory transaction, via the CESG.

Payments made in person, by phone or online via a Canadian financial institution:

  • HC Customer account number
  • Client Reference Number
  • Amount paid (Canadian $)

Payments made using an existing credit in a Health Canada Account:

  • HC Account Number containing the credit (e.g. DRSE0000, MDE0000)
  • Existing credit amount in the account

Stakeholders must never provide credit card, wire, or cheque payment information via the CESG. If payment is made by cheque, credit card, money order or wire:

  • A copy of the acknowledgment of receipt letter received from the CESG which includes the core ID #.
  • The corresponding payment instructions form (refer to Part A of the How to Pay Fees to HPFB document posted with the Drug Submission/Application Fee Form).
  • The payment in Canadian funds (cheque, money order, credit card information or the wire transaction receipt for funds that have been wired)

Must be sent, in paper format, to the following address:

Office of Submissions & Intellectual Property
ATTN: Cost Recovery
Therapeutic Products Directorate
Health Canada
101 Tunney's Pasture Driveway,
Finance Building
Address Locator 0201A1
Ottawa, Ontario
K1A 0K9
Fax: 613-941-0825

23. Can I send multiple transactions for a particular dossier at the same time? (New question 2016-12-22)

No. Regulatory transactions (sequences) for a dossier should be sent individually. Sponsors should ensure they have received the Health Canada acknowledgement for one transaction prior to sending a subsequent transaction.  If transactions are not received in the correct order, this will result in a missing sequence and an error “Sequence Numbering” (A07) will be generated during validation.

24. Is there a recommended time of day to send Regulatory Transactions? (New question 2016-12-22)

Consistent with the FDA Frequently Asked Questions regarding process and policies of the Electronic Submissions Gateway (ESG), Health Canada recommends that large regulatory transactions (between 5GB and 10GB) be sent after 4:30 PM EST.  This will allow your transaction to be processed and delivered to Health Canada overnight. For more information on providing large transactions refer to the FDA Frequently Asked Questions and Section 5.7 of the FDA ESG User Guide. Sponsors providing files greater than 10 GB should continue to use media. For detailed information on how to file using media, refer to Section 3.2 (ii) of the Guidance Document – Preparation of Regulatory Activities in eCTD Format.

Report a problem or mistake on this page
Please select all that apply:

Privacy statement

Thank you for your help!

You will not receive a reply. For enquiries, contact us.

Date modified: