Post-Notice of Compliance (NOC) Changes: Guidance for quality of veterinary drugs: Overview

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This guidance document has 3 main objectives:

  1. To provide guidance for post-Notice of Compliance (NOC) quality changes specifically for veterinary drugs.
  2. To assist with the classification of quality changes made to a new veterinary drug that has received a NOC pursuant to section C.08.004 of the Food and Drug Regulations(the Regulations).
  3. To provide sponsors guidance with respect to the reporting category and the recommendations on the data to support a quality related change.

Scope and application

This guidance document applies to sponsors intending to make changes to new veterinary drugs that have received a NOC pursuant to Section C.08.004 of the Regulations.

This guidance document is not applicable to veterinary biologics regulated by the Canadian Food Inspection Agency (CFIA), such as biological vaccines. Refer to applicable CFIA guidelines and policies for veterinary biologics.

Consult Health Canada's Post-Notice of Compliance (NOC) Changes: Quality - Guidance for Biologics pertaining to products regulated by the Biologic and Radiopharmaceutical Drugs Directorate (BRDD) when:

We encourage sponsors to consult with the Veterinary Drugs Directorate (VDD) for specifics of the conditions, data requirements and submission classifications.

ICH Q8, ICH Q9, ICH Q10 and ICH Q11 apply to medicinal products for human use only. However, the related concepts are also useful in the context of veterinary drug products. We advise sponsors of veterinary drugs submissions to refer to these relevant ICH guidelines.

Read this guidance document in conjunction with:

Information regarding general submission requirements and target performance standards may be found in the Veterinary drugs - Management of regulatory submissions guidance .


This guidance document replaces the guidance previously provided in Appendix 2: Quality Post-NOC Changes - Veterinary Drugs of the Guidance Document: Post-NOC Changes: Quality Document (2019). This document has been updated to provide clarity and consistency. It will be periodically updated with an emphasis on applying a science-based and risk-based approach to the pharmaceutical quality assessment of these products. Updated guidance documents are necessary to provide information to support quality changes to new drugs which apply a modernized, science-based, and risk-based approach to this area.

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Note about guidance documents in general

Guidance documents provide assistance to industry and health care professionals on how to comply with governing statutes and regulations. They also provide guidance to Health Canada staff on how mandates and objectives should be met fairly, consistently and effectively.

Guidance documents are administrative, not legal, instruments. This means that flexibility can be applied. However, to be acceptable, alternate approaches to the principles and practices described in this document must be supported by adequate justification. They should be discussed in advance with the relevant program area to avoid the possible finding that applicable statutory or regulatory requirements have not been met.

As always, Health Canada reserves the right to request information or material, or define conditions not specifically described in this document, to help us adequately assess the safety, efficacy or quality of a therapeutic product. We are committed to ensuring that such requests are justifiable and that decisions are clearly documented.

This document should be read along with the relevant sections of the Regulations and other applicable guidance documents.

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