1. How does the Common Electronic Submissions Gateway (CESG) work?
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:
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 3 illustrates the new ACK from the FDA which includes the MessageID and CoreID
5. Where can I find the time stamp that Health Canada received the regulatory transaction?
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:
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?
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?
10. What folder structure should be used when sending regulatory transactions via CESG?
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.
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 firstname.lastname@example.org
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 email@example.com.
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 firstname.lastname@example.org.
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 email@example.com.
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.
|FDA Term||Health Canada Term|
|FDA ESG (FDA Electronic Submissions Gateway)||CESG (Common Electronic Submissions Gateway)|
|Transaction Partner||Trading Partner|
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?
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:
Payments made using an existing credit in a Health Canada 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:
Must be sent, in paper format, to the following address:
Office of Submissions & Intellectual Property
ATTN: Cost Recovery
Therapeutic Products Directorate
101 Tunney's Pasture Driveway,
Address Locator 0201A1
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.