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Health Canada RSS - Electronic Submissions RSS FeedElectronic Submissions RSS Feed https://www.canada.ca/content/dam/hc-sc/migration/hc-sc/rss/dhp-mps/electronic-submissions-eng.xml Health Canada https://www.canada.ca/en/health-canada.html 2024-04-23T08:10:00-05:00 https://www.canada.ca/en/health-canada.html/images/templates/wmms.gif https://www.canada.ca/en/health-canada.html/images/common/sm-rss.gif Stay informed when new or updated information regarding electronic submissions in eCTD and non-eCTD format and the Regulatory Enrolment Process (REP) are posted on the Filing Submission Electronically section and Regulatory Enrolment Process section of the website. The material on this website is covered by the provisions of the Copyright Act, by Canadian laws, policies, regulations and international agreements. Such provisions serve to identify the information source and, in specific instances, to prohibit reproduction of materials without copyright clearance. Regulatory enrolment process (REP) https://www.canada.ca/en/health-canada/services/drugs-health-products/drug-products/applications-submissions/guidance-documents/regulatory-enrolment-process.html Health Canada https://www.canada.ca/en/health-canada.html 2026-05-22T12:15:00-04:00 2026-05-22T12:15:00-04:00 Regulatory enrolment process (REP) summary table was updated because the regulatory transaction template for medical devices is changing from v4.0.0 to 4.0.1. The material on this website is covered by the provisions of the Copyright Act, by Canadian laws, policies, regulations and international agreements. Such provisions serve to identify the information source and, in specific instances, to prohibit reproduction of materials without copyright clearance. Updated: Regulatory enrolment process https://www.canada.ca/en/health-canada/services/drugs-health-products/drug-products/applications-submissions/guidance-documents/regulatory-enrolment-process.html Health Canada https://www.canada.ca/en/health-canada.html 2026-03-25T14:00:00-04:00 2026-03-25T14:00:00-04:00 Regulatory enrolment process (REP) summary table was updated because REP is mandatory for medical device applications. The material on this website is covered by the provisions of the Copyright Act, by Canadian laws, policies, regulations and international agreements. Such provisions serve to identify the information source and, in specific instances, to prohibit reproduction of materials without copyright clearance. Updated: Regulatory enrolment process https://www.canada.ca/en/health-canada/services/drugs-health-products/drug-products/applications-submissions/guidance-documents/regulatory-enrolment-process.html Health Canada https://www.canada.ca/en/health-canada.html 2026-01-29T10:00:00-05:00 2026-01-29T10:00:00-05:00 We have updated the Regulatory transaction (RT) template version number for medical devices in the Regulatory enrolment process (REP) summary table on the REP webpage. The list of changes on the RT template is listed on the REP for Medical Devices Template Revision History. The material on this website is covered by the provisions of the Copyright Act, by Canadian laws, policies, regulations and international agreements. Such provisions serve to identify the information source and, in specific instances, to prohibit reproduction of materials without copyright clearance. Updated: Guidance document - Preparation of regulatory activities in non-eCTD format https://www.canada.ca/en/health-canada/services/drugs-health-products/drug-products/applications-submissions/guidance-documents/filing-submissions-electronically.html Health Canada https://www.canada.ca/en/health-canada.html 2025-11-27T11:10:00-05:00 2025-11-27T11:10:00-05:00 The non-eCTD guidance document has been updated to include revisions to Section 1.4 Scope and Application to add biocides, Section 2.1 to clarify cover letter requirements, and Appendix E to provide examples of folder structures. Appendix F Electronic Submission Gateway has been removed, and minor edits have been made throughout to improve clarity. The material on this website is covered by the provisions of the Copyright Act, by Canadian laws, policies, regulations and international agreements. Such provisions serve to identify the information source and, in specific instances, to prohibit reproduction of materials without copyright clearance. Updates to the master file application form and Biocides zip folder structure https://www.canada.ca/en/health-canada/services/drugs-health-products/drug-products/applications-submissions/guidance-documents/filing-submissions-electronically.html Health Canada https://www.canada.ca/en/health-canada.html 2025-11-05T14:30:00-05:00 2025-11-05T14:30:00-05:00 We have updated the Master File application form by moving the “Master file use” field above the “Master file type” field and by changing the “Job title” field from mandatory to optional. Reminder, as of June 2023, the Master file (MF) application form (.xml file) is required within every MF transaction that is sent via the electronic submission gateway to Health Canada. We have updated the compressed (zip) folder structure for biocides by removing the “5.7 Advertising” section. You can download the updated folder structure, use it to prepare a biocide regulatory transaction, and send it via the electronic submission gateway to Health Canada. The material on this website is covered by the provisions of the Copyright Act, by Canadian laws, policies, regulations and international agreements. Such provisions serve to identify the information source and, in specific instances, to prohibit reproduction of materials without copyright clearance. Revision to third party authorization form https://www.canada.ca/content/dam/hc-sc/documents/services/drugs-health-products/drug-products/applications-submissions/form/third-party-authorization.pdf Health Canada https://www.canada.ca/en/health-canada.html 2025-09-12T12:00:00-04:00 2025-09-12T12:00:00-04:00 A third party authorization form is now required within the initial/first transaction of each regulatory activity, when the regulatory contact for an activity, is a third party acting on behalf of the manufacturer/sponsor. The material on this website is covered by the provisions of the Copyright Act, by Canadian laws, policies, regulations and international agreements. Such provisions serve to identify the information source and, in specific instances, to prohibit reproduction of materials without copyright clearance. Updated: Regulatory enrolment process https://www.canada.ca/en/health-canada/services/drugs-health-products/drug-products/applications-submissions/guidance-documents/regulatory-enrolment-process.html Health Canada https://www.canada.ca/en/health-canada.html 2025-09-10T8:19:00-04:00 2025-09-10T8:19:00-04:00 Updated the REP Summary Table due to the updated Regulatory Transaction Template for Human and Veterinary Drugs and Disinfectants. The material on this website is covered by the provisions of the Copyright Act, by Canadian laws, policies, regulations and international agreements. Such provisions serve to identify the information source and, in specific instances, to prohibit reproduction of materials without copyright clearance. Updated: Filing submissions electronically https://www.canada.ca/en/health-canada/services/drugs-health-products/drug-products/applications-submissions/guidance-documents/filing-submissions-electronically.html Health Canada https://www.canada.ca/en/health-canada.html 2025-04-25T10:00:00-04:00 2025-04-25T10:00:00-04:00 Biocides zip folder structure has been posted on the Filling submission electronically web page. These zipped files can be downloaded and used to prepare a regulatory transaction. The material on this website is covered by the provisions of the Copyright Act, by Canadian laws, policies, regulations and international agreements. Such provisions serve to identify the information source and, in specific instances, to prohibit reproduction of materials without copyright clearance. Updated: Regulatory enrolment process (REP) https://www.canada.ca/en/health-canada/services/drugs-health-products/drug-products/applications-submissions/guidance-documents/regulatory-enrolment-process.html Health Canada https://www.canada.ca/en/health-canada.html 2025-03-27T14:00:00-04:00 2025-03-27T14:00:00-04:00 Updated the REP Summary Table due to the updated Regulatory Transaction Template for human drugs, veterinary drugs and disinfectants. The material on this website is covered by the provisions of the Copyright Act, by Canadian laws, policies, regulations and international agreements. Such provisions serve to identify the information source and, in specific instances, to prohibit reproduction of materials without copyright clearance. Updated: Filing submissions electronically https://www.canada.ca/en/health-canada/services/drugs-health-products/drug-products/applications-submissions/guidance-documents/filing-submissions-electronically.html Health Canada https://www.canada.ca/en/health-canada.html 2025-01-27T14:45:00-05:00 2025-01-27T14:45:00-05:00 Biocides dossier request form, changes on FSE website and in the sequence description document. The material on this website is covered by the provisions of the Copyright Act, by Canadian laws, policies, regulations and international agreements. Such provisions serve to identify the information source and, in specific instances, to prohibit reproduction of materials without copyright clearance. Updated: Validation rules for regulatory transactions in electronic Common Technical Document (eCTD) format https://www.canada.ca/en/health-canada/services/drugs-health-products/drug-products/applications-submissions/guidance-documents/ectd/notice-validation-rules-regulatory-transactions-submitted-health-canada-electronic-common-technical-document-format-2016-12-1.html Health Canada https://www.canada.ca/en/health-canada.html 2025-01-10T14:05:00-05:00 2025-01-10T14:10:00-05:00 Updating the validation rules for regulatory transactions in eCTD format. The material on this website is covered by the provisions of the Copyright Act, by Canadian laws, policies, regulations and international agreements. Such provisions serve to identify the information source and, in specific instances, to prohibit reproduction of materials without copyright clearance. Updated: Validation rules for regulatory transactions in non-eCTD format https://www.canada.ca/en/health-canada/services/drugs-health-products/drug-products/applications-submissions/guidance-documents/common-technical-document/notice-validation-rules-non-ectd-electronic-only-format.html Health Canada https://www.canada.ca/en/health-canada.html 2025-01-10T14:05:00-05:00 2025-01-10T14:10:00-05:00 Updating the validation rules for regulatory transactions in non-eCTD format. The material on this website is covered by the provisions of the Copyright Act, by Canadian laws, policies, regulations and international agreements. Such provisions serve to identify the information source and, in specific instances, to prohibit reproduction of materials without copyright clearance. Updated: Regulatory enrolment process https://www.canada.ca/en/health-canada/services/drugs-health-products/drug-products/applications-submissions/guidance-documents/regulatory-enrolment-process.html Health Canada https://www.canada.ca/en/health-canada.html 2024-12-11T10:10:00-04:00 2024-12-11T10:10:00-04:00 Updated the REP Summary Table due to the updated Company Template, Regulatory Transaction Template, Application Information Template for Medical Devices. The material on this website is covered by the provisions of the Copyright Act, by Canadian laws, policies, regulations and international agreements. Such provisions serve to identify the information source and, in specific instances, to prohibit reproduction of materials without copyright clearance. Updated: Regulatory enrolment process (REP) https://www.canada.ca/en/health-canada/services/drugs-health-products/drug-products/applications-submissions/guidance-documents/regulatory-enrolment-process.html Health Canada https://www.canada.ca/en/health-canada.html 2024-10-28T10:10:00-04:00 2024-10-28T10:10:00-04:00 Updated the REP Summary Table due to the updated Regulatory Transaction Template for Human and Veterinary Drugs and Disinfectants. The material on this website is covered by the provisions of the Copyright Act, by Canadian laws, policies, regulations and international agreements. Such provisions serve to identify the information source and, in specific instances, to prohibit reproduction of materials without copyright clearance. Updated: Regulatory enrolment process (REP) https://www.canada.ca/en/health-canada/services/drugs-health-products/drug-products/applications-submissions/guidance-documents/regulatory-enrolment-process.html Health Canada https://www.canada.ca/en/health-canada.html 2024-07-31T10:30:00-04:00 2024-07-31T10:30:00-04:00 Voluntary use of REP is available for Medical Devices. The material on this website is covered by the provisions of the Copyright Act, by Canadian laws, policies, regulations and international agreements. Such provisions serve to identify the information source and, in specific instances, to prohibit reproduction of materials without copyright clearance.

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