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February 19, 2016
Our file number: 16-101003-724
Health Canada is pleased to announce to the release of the revised form Post-Notice of Compliance (NOC) Changes: Level III.
As a consequence of the revisions made to the Guidance Document: Post-Notice of Compliance (NOC) Changes: Quality Document, modifications have been made to the related form. Section B of the Post-NOC Changes: Level III PDF fillable form has been revised.
The revisions made to the Guidance Document: Post-Notice of Compliance (NOC) Changes: Quality Document are found in Appendices 1, 2, 3, 5, and 8.
Only the Level III Changes form that is currently posted on the Health Canada website will be accepted.
Level III changes form should be filed at the time the changes are implemented for the following:
Level III changes forms should not be provided for the following:
Sponsors should complete a separate Level III Changes form for each drug product and save them as separate PDF files.
A cover letter should not be provided in a regulatory transaction with a Level III Changes form.
Supporting data should not be provided with the Level III Changes form. If additional information is required, it will be requested. Any supporting data provided without request will be destroyed or returned to the sponsor at their own expense.
Health Canada strongly recommends that all Post-NOC Changes: Level III forms are filed in eCTD format via the Common Electronic Submission Gateway (CESG). Refer to the Guidance Document: Preparation of Regulatory Activities in the Electronic Common Technical Document (eCTD) format for detailed instructions.
If not provided in eCTD format, the forms should be filed in "non-eCTD electronic-only" format. Refer to the Guidance Document: Preparation of Regulatory Activities in the "Non-eCTD Electronic-Only" format for detailed instructions.
Health Canada will not accept Level III Changes forms provided in paper format.
Questions regarding how to file Level III Changes forms should be directed to eReview@hc-sc.gc.ca.