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)

View complete guide

Download PDF (xx KB, xx pages)

Details and history

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

For assistance

Our service hours are Monday to Friday from 8 a.m. to 4 p.m. (local time) and closed statuary holidays.

By email: hc.vdd.vetdrugs-medsvet.dmv.sc@canada.ca

By phone: 613-954-5687

Contact us by mail:

Veterinary Drugs Directorate (VDD)
Holland Cross Complex
Ground Floor
14 - 11 Holland Ave
Postal Locator 3000A
Ottawa, Ontario K1A 0K9

Service standards: We reply to mail within 15 business days. If we can't answer your question right away, we will send you an estimated date.