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

On this page

• Objectives
• Scope and application
• Background
• Document change log
• Note about guidance documents in general

Objectives

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:

• biotechnological tools are used at any stage during the synthesis of the drug substance(s). For example:
  • DNA cloning
  • gene targeting
  • rDNA technology
• biological processes, such as fermentation, are used during the manufacturing of a veterinary drug product

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:

• Post-Notice of Compliance (NOC) Changes: Framework Document - Guidance for Veterinary Drugs
• Post-Notice of Compliance (NOC) Changes: Safety and Efficacy Document - Guidance for Veterinary Drugs
• other related Health Canada guidance documents

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

Background

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.

Document change log

• Appendix 2 of the Guidance Document: Post-Notice of Compliance (NOC) Changes: Quality Document (2019) has been made into a separate document for veterinary drugs.
• The guidance has been reformatted to allow for web publishing.
• A complete Certified Product Information Document (CPID) is recommended for all quality-related post-NOC changes. Refer to a new section "Supporting data - Certified Product Information Document (CPID)" in the guidance.
• Comments received from the industry during consultation have been incorporated throughout the guidance.
• Change examples have been added, removed, or revised to clarify requirements and to address the request from industry for additional guidance. Notable areas where this guidance has been revised are:
  • New examples added to include separate requirements for starting materials, intermediates, and final drug substance
  • New example added for changes involving Certificate of Suitability (CEP)
  • New example added for changes involving container closure system
  • New example added for changes involving product in-use stability period
  • Merged examples as the same requirements are applied to all immediate release dosage forms including medicated premixes
  • Merged examples for the changes involving post-approval stability protocol
  • Several changes now have multiple categories of changes to allow industry more flexibility in submission of changes
  • Some conditions and supporting data for certain changes have been removed or revised to clarify the requirements
  • Supporting data concerning process parametric release has been revised to clarify the expectations.
  • Overall updates to the text have been made to provide more clarity of the requirements
  • References to related guidance documents have been added or revised (including VICH and ICH guidelines, and Health Canada's guidance on parametric release)

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.

Related Links

• Veterinary drugs - Management of regulatory submissions guidance
• Post-Notice of Compliance changes: Framework document for veterinary drugs
• Post-Notice of Compliance changes: Guidance for safety and efficacy of veterinary drugs