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Natural Health Products Compliance and Enforcement Policy

Changes to the Natural Health Products licensing of a natural health product (NHP) have been implemented and the introduction of a new policy and process improvement. The Government has introduced a new approach to NHPs that provides a stable, predictable regulatory environment for the efficient processing of applications. This will ensure an expedited application review and focus evaluation on complex applications of a product

The Natural Health Products (Unprocessed Product License Applications) Regulations (NHP-UPLAR) will no longer be in effect as of February 4, 2013 as the government has introduced a new approach to the regulation of natural health products (NHP).  This also means that no new Exemption Numbers (ENs) for natural health products will be issued, and that Health Canada will be transitioning toward the requirement that all natural health products sold in Canada have Natural Product Numbers (NPN’s), or Homeopathic Medicine Number (DIN-HM) on the label.  Health Canada is also developing a new approach to site licensing focusing on greater quality assurance for products. Product licensing decisions will be made in 180 days or less. On certain types of products the license decision will be made within 30 days.

Phase-In approach

There will be a phase-in transition period over 18 months starting March 1, 2013. The transition will be in two 9-month phases. The first phase will focus on compliance and complying to the regulations requirements. The second phase is to discontinue products with non-compliant formulations and labeling or packaging.

Health Products

A natural health product is referred to the following items:

  • vitamin and mineral supplements;
  • herbal and other plant-based health products;
  • traditional medicines ,e.g. Chinese medicine;
  • homeopathic medicines; -probiotics and enzymes and
  • certain personal care products containing natural ingredients.

Effective date

As of September 1, 2014 all natural health products will have a natural product number or a drug identification number homeopathic medicine number for all products. Only authorized natural health products can be imported or manufactured and be sold, otherwise be subject to compliance and enforcements noted in Policy POL-0044.

FAQ on natural health products

View the questions and answers for the ending of Natural health products unprocessed product license applications regulations.

For more general information and details consult the Health Canada website.