Notice: Submitting Master File Transactions via the Common Electronic Submissions Gateway

November 29, 2019
Our file number: 19-119715-376 

Health Canada is pleased to announce that as of January 1, 2020, all regulatory transactions for Master Files prepared in the non-eCTD format must be sent via the Common Electronic Submission Gateway (CESG).

The CESG allows for the secure and rapid transmission of regulatory transactions to Health Canada. It has been in operation at Health Canada since February 2014, and has been the mandatory method of transmission for transactions in eCTD format since January 2017. 

Summary of requirements:
Effective Date Regulatory Transactions Format of Transactions: Transmission of Transactions

January 1, 2020

New Master Files

Mandatory in eCTD format (as per Notice Mandatory use of eCTD format)

MandatoryTable 1 Footnote * submission via the CESG for all Master File transactions filed in eCTD and non-eCTD formats.

Existing Master Files

Recommended in eCTD format, however non-eCTD format will also be accepted.

Table 1 Footnote *

Note: Regulatory transactions greater than 10 gigabyte (GB) in size cannot be sent via the CESG; media must be used in such cases.

Table 1 Return to footnote * referrer

The following documents should be used in preparing a Master File (MF) transaction for filing to Health Canada:

Questions or comments regarding this notice can be sent to hc.ereview.sc@canada.ca.

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