Post-NOC Level III Change Updates

Author: Karen Zhou

A post-NOC change is any change made to a new drug that has received a notice of compliance (NOC) pursuant to C.08.004 of the Food and Drug Regulations. In Health Canada’s risk-based framework, such changes are reported in one of four categories: Level I (Supplements), Level II (Notifiable Changes), Level III (Annual Notifications), Level IV (Record of Changes) based on criteria outlined in related guidance documents.

Level III changes, also known as minor quality changes, have minimal potential to have an adverse effect on the identity, strength, quality, purity, or potency of the drug product. Level III changes are filed annually, or at the time changes are implemented, using a Post-Notice of Compliance (NOC) Changes (Level III) Changes form. In an updated Guidance: Post-Notice of Compliance (NOC) Changes: Quality Document (effective November 28, 2018) followed by the notice Revision to the Post-Notice of Compliance (NOC) Changes - Notices of Change: Level III Form (November 30, 2018), Health Canada has clarified when Level III changes should be filed and what documentation should be submitted.

Level III changes should be filed for:

· Drugs pursuant to C.08.004, or New Drugs;

· New Drugs for which a NOC has been recommended but has not been issued yet; or

· DIN-B drugs pursuant to C.01.014.2.

Additionally, supporting data for a Level III change need not be submitted but should be made available to Health Canada within 30 days upon request.

Level III changes should not be filed for:

Pursuant to C.01.014.2, the following DIN types:

· DINA, DIND, DINF, VDIN

Administrative details:

· One Level III change form (in PDF) per drug product, and no cover letter is required.

· Recommended submission format: eCTD format via CESG. Otherwise, submission should be filed in the “non-eCTD electronics-only” format. Guidance documents for these two submission formats are available on the Health Canada website.

· Paper format is no longer accepted.

Questions or comments:

Office of Submissions and Intellectual Property (OSIP)

Therapeutic Products Directorate

Health Canada

Tunney's Pasture, Finance Building #2

Address Locator: 0201A1

Ottawa, Ontario

K1A 0K9

Facsimile: 613-957-4140

Email: hc.ereview.sc@canada.ca

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