Guidance document on classification of veterinary drugs and livestock feeds - profile page

From: Health Canada and Canadian Food Inspection Agency (CFIA)

Overview

This guidance provides criteria for the classification of veterinary drugs and livestock feeds. It includes information to help manufacturers determine the applicable regulatory and submission processes.

Who this guide is for

Those looking for guidance on classifying oral products for livestock, as a feed or a drug, such as:

• Pharmaceutical companies
• Animal feed manufacturers
• Manufacturers and distributors of Veterinary Health Products

In this guide

• 1. Introduction
  • 1.1 Background
  • 1.2 Definitions
  • 1.3 Context
  • 1.4 Purpose and objectives
• 2. Scope and application
  • 2.1 Scope
  • 2.2 Application
• 3. Guiding principles
• 4. Classification criteria
  • 4.1 Route of administration
  • 4.2 Mode of administration
    • 4.2.1 Final product form
    • 4.2.2 Forceable administration
  • 4.3 Known medicinal ingredients
  • 4.4 Representation/intended purpose
    • 4.4.1 Therapeutic indications (claims)/purposes
    • 4.4.2 Nutritional indications (claims)/purposes
  • 4.5 Composition
    • 4.5.1 Type of ingredients
    • 4.5.2 Concentration (or level) of ingredients
  • 4.6 Directions for use
    • 4.6.1 Dosage recommendations/feeding rates
    • 4.6.2 Duration of treatment/feeding and timing of administration
  • 4.7 Mode of action
    • 4.7.1 Therapeutic modes of action
    • 4.7.2 Nutritional modes of action
• 5. Classification decision process
• 6. Implementation

List of appendices

• Appendix A - Nutritional disorders
• Appendix B - Drug/Feed classification flowchart
• Appendix C - List of known medicinal ingredients
• Appendix D - Stress-Related Indications (or Claims)
• Appendix E-1 - Mycotoxin Detoxification Agents (MDAs)
• Appendix E-2 - Viable Microbial Products (VMPs)

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Details and history

• Published: February 27, 2019
• Part of topic(s): Guidance document on classification of veterinary drugs and livestock feeds

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