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Drugs and Health Products

Canada Vigilance Program

The Canada Vigilance Program is Health Canada's post-market surveillance program that collects and assesses reports of suspected adverse reactions to health products marketed in Canada. Post-market surveillance enables Health Canada to monitor the safety profile of health products once they are marketed to ensure that the benefits of the products continue to outweigh the risks.

The Canada Vigilance Program has collected reports of suspected adverse reactions since 1965. Adverse reaction reports are submitted by health professionals and consumers on a voluntary basis either directly to Health Canada or via Market Authorization Holders. The following health products marketed in Canada are collected by the program: prescription and non-prescription medications; natural health products; biologics (includes biotechnology products, vaccines, fractionated blood products, human blood and blood components, as well as human cells, tissues and organs); radiopharmaceuticals; and disinfectants and sanitizers with disinfectant claims. The information collected by the program can be accessed through the Canada Vigilance Online Database.

The Canada Vigilance Program is supported by seven Canada Vigilance Regional Offices who provide a regional point-of-contact for health professionals and consumers. Reports are collected by the regional offices before being forwarded to the Canada Vigilance National Office for further analysis.

The Canada Vigilance Program provides a variety of tools for health professionals and consumers to report suspected adverse reactions. Reporting is simple and can be done online, by phone or by submitting the Side Effect Reporting Form by fax or mail.

Announcements

  • 2011-10-25 - Updates to the Guidance Document for Mandatory Problem Reporting for Medical Devices and the Mandatory Medical Device Problem Reporting Form for Industry
  • 2011-03-17 - Announcement - Release of the Guidance Document for Industry - Reporting Adverse Reactions to Marketed Health Products
  • 2009-11-13 - Announcement - Launch of the Re-designed Canada Vigilance Adverse Reaction Online Database
  • 2009-08-19 - Release of the Guidance Document for Industry - Reporting Adverse Reactions to Marketed Health Products

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