Summary: Recall policy for health products

Overview

This policy outlines what is expected of those planning for, and conducting recalls of health products in Canada. These requirements are set out by:

• the Food and Drugs Act (the Act)
• Food and Drug Regulations (FDR)
• Medical Devices Regulations (MDR)
• Natural Health Products Regulations (NHPR)
• Blood Regulations
• Processing and Distribution of Semen for Assisted Conception Regulations
• Safety of Human Cells, Tissues and Organs for Transplantation Regulations

Who this policy is for

This policy is for people who work with:

• drugs as: sellers, distributors, manufacturers, importers, packagers, labelers and wholesalers
• medical devices as: sellers, distributors, manufacturers and importers
• natural health products as: product licence holders, manufacturers, importers, packagers, labellers and distributors
• blood products including sellers
• cells, tissues and organs for transplantation
• semen for assisted conception, as: sellers, processors and distributors

In this policy

• 1. Purpose
• 2. Scope.
• 3. Policy Statement
• 4. Roles & Responsibilities
  • 4.1 Responsible Parties
  • 4.2 Regulatory Operations and Enforcement Branch
• Appendix A - Mandatory Actions
• Appendix B - Glossary
  • Acronyms
  • Terms
• Appendix C - Contact information
• Appendix D - References

View complete policy
Download PDF (1.1 MB, 27 pages)

Details and history

Date issued: August 15, 2019

Date of implementation: August 15, 2019

For assistance

For general inquiries:

For drugs and natural health products by email: hc.hpce-cpsal.sc@canada.ca.
For medical devices by email: hc.mdcu-ucim.sc@canada.ca.
For blood, cells, tissues, organs and semen by email: hc.bpcp-pcpb.sc@canada.ca