How post-market activities should be carried out for NHP in Canada?
In Canada, the Natural and Non-prescription Health Products Directorate (NNHPD) of Health Canada regulates Natural Health Products (NHPs). After an NHP is authorized for sale in Canada, the manufacturer or distributor must conduct post-market activities to monitor the safety and efficacy of the product.
These activities may include:
- Adverse Reaction Reporting: Manufacturers and distributors are required to report any adverse reactions to Health Canada. Consumers can also report adverse reactions directly to Health Canada through the Canada Vigilance Program.
- Quality Assurance: A system must be in place for manufacturers and distributors to guarantee the product’s continued safety, efficacy, and quality.
- Labelling and Advertising: The Food and Drugs Act and the Natural Health Products Regulations must be complied with by the product label and advertising. The NNHPD may review product labelling and advertising to ensure compliance.
- Market Surveillance: The NNHPD may conduct market surveillance activities to identify and address any safety or quality issues related to NHPs.
- Compliance and Enforcement: Health Canada may act against manufacturers or distributors who do not comply with the regulations.
In summary, post-market activities for NHPs in Canada are designed to ensure that the products remain safe, effective, and high-quality. Manufacturers and distributors must record adverse reactions, implement a quality assurance programme, adhere to labelling and advertising regulations, and abide by market monitoring activities and Health Canada’s enforcement actions.