Summary of Drug and natural health products recall guide

Overview

This guide is for anyone working with drugs or natural health products. It will help facilitate understanding and compliance with sections of the Food and Drugs Act (the Act), the Food and Drug Regulations (FDR) and Natural Health Products Regulations (NHPR) that relate to recalls.

Who this policy is for

This policy is for people who work with:

• drugs as: sellers, distributors, manufacturers, importers, packagers, labelers and wholesalers
• natural health products as: product licence holders, manufacturers, importers, packagers, labellers and distributors

In this policy

• 1. Purpose
• 2. Scope
• 3. Introduction
• 4. Roles and responsibilities
  • Establishments in the distribution chain
  • The responsible party
  • Consignees
  • Health Canada
• 5. Recalling drugs and natural health products
  • Health risk assessment
  • Recall notification to Health Canada
  • Recall strategy
  • Recall closure: final report
• 6. Food and Drug Regulations requirements for recalls
  • Reporting
  • Manufacturing control
  • Records
• 7. Natural Health Products Regulations requirements for recalls
  • Records
  • Recall reporting
  • Operations
  • Quality assurance
  • Records
• Appendices
  • Appendix A – Glossary
    • Acronyms
    • Terms
  • Appendix B – Questions for determining medical necessity of a drug product
  • Appendix C – Sample Drug recall communication template
  • Appendix D – References
  • Appendix E – Health Canada contacts for reporting drug and natural health product recalls

View complete guide

Download PDF (1.64 MB, 59 pages)

Details and history

Date issued: October 24, 2019

Date of implementation: October 24, 2019

For assistance

For general inquiries: For drugs and natural health products by email: hc.hpce-cpsal.sc@canada.ca.