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)	Mandatory^{Table 1 Footnote *} submission via the CESG for all Master File transactions filed in eCTD and non-eCTD formats.
January 1, 2020	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:

For information regarding the CESG accounts and use, refer to the CESG information page and the User Guide.

Sponsors are strongly advised to obtain CESG accounts as soon as possible, to prepare for mandatory filing regulatory transactions via CESG by January 1, 2020. Master File transactions sent on media (CD, DVD, USB, etc.) after this date will be rejected by Health Canada, unless they are greater than the 10 GB size limit.
For information on the format, structure, document placement, and filing of a MF, refer to the documents listed below which are available on the Filing Submissions Electronically information webpage:
- Guidance Document: Preparation of Regulatory Activities in the Electronic Common Technical Document (eCTD) Format;
- Notice - Mandatory use of eCTD Format;
- Organisation and Document Placement for Canadian Module 1 of the Common Technical Document (CTD) Structure;
- Regulatory Transaction Descriptions;
- Validation Rules for regulatory transactions filed in eCTD format;
- Validation Rules for regulatory transactiosn filed in non-eCTD format; and
- Guidance Document: Preparation of Regulatory Activities in the Non-eCTD Electronic-Only Format
For information regarding the content of a MF regulatory activity, refer to the Guidance Document: Master Files (MFs) - Procedures and Administrative Requirements Guidance Document on the Health Canada webpage.

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

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

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