January 29, 2013
This page replaces the previous cover letter to the Inspectorate's Natural Health Products Compliance and Enforcement Policy (POL-0044) of August 27, 2010. Policy POL-0044 describes the compliance and enforcement approach with respect to natural health products (NHPs) under the Food and Drugs Act (FDA) and the Natural Health Products Regulations (NHPR), and is intended to be used in conjunction with the Compliance and Enforcement Policy (POL-0001).
Over the past year, Health Canada has been consulting on, and rolling out, a new approach to natural health products (NHPs). The approach introduces new policies and process improvements to expedite application review and focus evaluation efforts on complex applications. Ultimately, it provides a stable, predictable regulatory environment.
As planned, the Natural Health Products (Unprocessed Product Licence Applications) Regulations (NHP-UPLAR) will no longer be in effect as of February 2013. This means that no new Exemption Numbers (ENs) for NHPs will be issued, and that Health Canada will be transitioning toward the requirement that all NHPs sold in Canada have natural product numbers (NPNs), or Homeopathic Medicine Number (DIN-HM) on the label.
Health Canada has developed a transition plan--using key input from stakeholders--that provides time for companies to make necessary adjustments to business practices and/or phase out products that are not in compliance. There will be an 18 month transition period starting March 1, 2013, that is further broken down into two 9-month phases, described in more detail below. This transition plan received strong endorsement during public consultations, with approximately three quarters of all respondents showing their support.
As of this date, Health Canada's expectation is that all NHPs will have an NPN or DIN-HM before coming onto the market. This applies to all levels of the supply chain, including retail. Companies must only import, manufacture and sell NHPs with market authorisation (NPN or DIN-HM) and respect the terms of their market authorisation. NHPs without market authorisation may be subject to compliance and enforcement activities.
The Inspectorate's Natural Health Products Compliance and Enforcement Policy (POL-0044) was published with the "Annex to the Natural Health Products Compliance and Enforcement Policy for exempt NHPs under the Natural Health Products (Unprocessed Product Licence Applications) Regulations (NHP-UPLAR) (POL-0093)". The annex was developed in order to provide clarification on the compliance and enforcement approach for products that are exempt under the NHP-UPLAR. With the repeal of the NHP-UPLAR, the annex will be removed.
Inquiries about this document can be addressed to the Drug Compliance Verification and Investigation Unit by fax: (613) 946-5636 or by email: DCVIU_UVCEM@hc-sc.gc.ca.