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.
- Side Effect Reporting Form
- Online Reporting to the Canada Vigilance Program
- Fact Sheets
- Search the Canada Vigilance Online Database
- Learning Material - Adverse Reaction Reporting
- Consumers and Patients - Reporting Side Effects from Your Medicine: What you need to know
- Health Professional Reporting of Adverse Drug Reactions
- Reporting of Adverse Reactions for Natural Health Products
- Contact a Canada Vigilance Regional Office
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