Health Canada
Symbol of the Government of Canada

Common menu bar links

Drugs and Health Products

The Inspectorate's Natural Health Products Compliance and Enforcement Policy (POL-0044)

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).

Background

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.

Transition Period

  1. First 9-month Period (March 1, 2013 - November 30, 2013)

    The first 9 months of the transition period will focus on compliance promotion. During this time, Health Canada will work to enhance awareness of the NHPR so that companies have what they need to understand and comply with the Regulations. Unless a risk to health or additional non-compliances are identified, NHPs that have an active submission number with the Natural Health Products Directorate (NHPD) or approved NHPs that have undergone minor modifications during the licensing process which are not yet reflected in the current labelling, will be a lower priority for enforcement at all levels of the distribution chain.

    Companies should use this time to review their product(s) status and supply and should begin to phase out products without market authorisation and authorised products with old, non-compliant formulations, labelling or packaging.

  2. Second 9-month Period (December 1, 2013 - August 31, 2014)

    During the following 9 months of the transition period, companies should continue to phase out products at the retail level that do not have market authorization, or products with old, non-compliant formulations, labelling or packaging. Products that have an active submission number with the NHPD or products that have undergone minor modifications which are not reflected in the current labelling, will be considered a lower priority for enforcement, unless a risk to health or additional non-compliances are identified.

    At the importation and manufacturing level, NHPs will be expected to have market authorisation and respect the terms of their market authorisations, including formulation and labelling.

Following the transition period (September 1, 2014)

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.

Removal of Policy POL-0093

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.

Contact Information

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.