Adverse reaction reporting for Natural Health Products in Canada
Adverse reaction reporting for Natural Health Products in Canada
In Canada, under the Natural Health Products Regulations, adverse reaction reporting for natural health products (NHPs) is required by law. Manufacturers, importers, and distributors of NHPs must have an appropriate system to collect and report adverse reactions to Health Canada’s Canada Vigilance Program.
1. The manufacturer, importer or distributor must report to Health Canada within 15 days when they learn of any adverse reaction occurring in a consumer.
The report must include the following:
- Information about the NHP,
- The adverse reaction, and
- Any action taken in response to the reaction.
The report can be submitted online through the Canada Vigilance Online Adverse Reaction Reporting Form or by mail using the Canada Vigilance Adverse Reaction Reporting Form.
2.Consumers are also encouraged to report adverse reactions directly to Health Canada through the Canada Vigilance Program. This can be done by phone, email, or using the Canada Vigilance Online Adverse Reaction Reporting Form.
Health Canada uses the information collected through adverse reaction reporting to monitor the safety of NHPs and take necessary action to protect consumer health. Manufacturers, importers, and distributors of NHPs are required to cooperate with Health Canada in the investigation of adverse reactions and to provide any additional information requested by Health Canada [1].
