Compliance and Enforcement Policy (POL-0001)

Overview

As part of its regulatory responsibilities, Health Canada monitors compliance, undertakes enforcement activities and works towards preventing non-compliance with the legislation that Health Canada administers. This policy describes Health Canada’s national compliance and enforcement approach for health products regulated under the Food and Drugs Act and its regulations.

Who this guide is for

Anyone conducting a regulated activity under the Act has prescribed responsibilities for the safety, efficacy and quality of health products to be sold in Canada. Other parties may also be subject to the Act although they may not require an authorization from Health Canada to perform certain activities.

As new health products and activities emerge and become regulated under the umbrella of the Act and its regulations, this policy will apply to the oversight of these products and activities.

In this guide

1. Introduction
2. Purpose
3. Background
4. Scope
5. Guiding principles
   1. Evidence-based
   2. Risk-based approach
   3. Fairness, consistency and impartiality
   4. Transparency
6. Role of Health Canada
7. Roles and responsibilities of other parties
   1. Regulated parties
   2. Healthcare practitioners
   3. Retailers
8. Compliance and enforcement actions and tools
   1. Compliance promotion
   2. Compliance monitoring
   3. Enforcement
      • Enforcement Responses
      • Other Enforcement Responses – Investigation and Prosecution

• Appendix A – Glossary
  • Acronyms
  • Terms
• Appendix B – References