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Drugs and Health Products

Notice - Post-Notice of Compliance (NOC) Changes: Notices of Change (Level III) Form

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Contact: eReview

Notice

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.

1. Introduction

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.

2. When to file

Level III changes form should be filed at the time the changes are implemented for the following:

  • New drugs that have received an NOC pursuant to section C.08.004 of the Food and Drug Regulations. These drugs may include pharmaceuticals, biologics, and radiopharmaceuticals for human use and pharmaceuticals, radiopharmaceuticals and certain biotechnological products for veterinary use.
  • New drugs for which an NOC has been recommended but issuance of the NOC has been placed on hold.
  • Drugs regulated under Part C, Division 1 of the Food and Drug Regulations that have received a drug identification number (DIN) pursuant to Section C.01.014.2 for Drug Identification Number applications - Biologic products (DIN-B).

Level III changes forms should not be provided for the following:

  • Drugs regulated under Part C, Division 1 of the Food and Drug Regulations that have received a drug identification number (DIN) pursuant to Section C.01.014.2 for the following DIN types:
    • Drug Identification Number Application (DINA)
    • Disinfectant Drug Identification Number Application (DIND)
    • Category IV Monograph Drug Identification Number Application (DINF)
    • Veterinary Drug Identification Number Application (VDIN)

3. File Format and Content

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.

4. How to File

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.