Canada Vigilance - A New Name for the Canadian Adverse Drug Reaction Monitoring Program

Health Canada announces Canada Vigilance as the new name for the Canadian Adverse Drug Reaction Monitoring Program. Canada Vigilance is Health Canada's post-market surveillance program that collects and assesses adverse reaction (AR) reports to the following marketed health products: pharmaceuticals, biologics (including fractionated blood products, as well as therapeutic and diagnostic vaccines), natural health products and radiopharmaceuticals. Canada Vigilance is a program of MedEffect Canada.

In conjunction with the name change, regional AR monitoring offices will now be referred to as Canada Vigilance Regional Offices. The Canada Vigilance Regional Offices work collaboratively with the Canada Vigilance National Office to collect reports submitted by health professionals and consumers.

The reporting mechanism remains the same. To report an adverse reaction, request a copy of the Canada Vigilance Reporting Form or to obtain information about the program, health professionals and consumers may use the Canada Vigilance Toll Free Phone and Fax Lines:

Telephone: 1-866-234-2345
Fax: 1-866-678-6789

The Health Canada Web site is a valuable source of adverse reaction information. To download a copy of the Canada Vigilance Reporting Form, to report an adverse reaction online, or to join Health Canada's MedEffect e-Notice and receive the Canadian Adverse Reaction Newsletter and health product advisories free by e-mail, visit our website.

Market authorization holders will continue to send reports directly to the Canada Vigilance National Office. Mandatory reporting requirements for health product market authorization holders are outlined in the Food and Drugs Act and Regulations, and remain unchanged.