Legislation and Guidelines

In Canada, natural health products (NHP's) fall under the Natural Health Products Regulations of the Food and Drugs Act. These Regulations came into effect on January 1, 2004, after extensive consultations with stakeholders and the Canadian public on an appropriate regulatory framework for natural health products.

Several guidance documents have been created to provide industry with clear guidelines on how to comply with the Regulations.

In addition, a compliance policy is in place to ensure the safety of Canadians until all natural health products have undergone Health Canada's approval process.

Natural Health Products Regulatory Review

At the time that the Natural Health Products Regulations came into force, a commitment was made to undertake a review of the regulations within the first three to five years of their implementation. This review has been launched further to that commitment and in consideration of challenges and issues which have been identified in the first three years of regulating NHPs.

The Natural Health Products Regulatory Review (the Review) is being undertaken as part of the Health Products and Food Branch's (HPFB) Blueprint for Renewal initiative, which aims at modernizing the regulatory system for all health products and food regulated by Health Canada.

The following information is available on the Review.

• Discussion Paper - Charting A Course: Refining Canada's Approach to Regulating Natural Health Products