Progress Report - Regulation of Natural Health Products

The Government of Canada is committed to making sure that the regulation of natural health products balances your health and safety with your freedom to choose alternative products.

The Natural Health Products Regulations were implemented in 2004 after extensive consultations with stakeholders, consumers, and the Standing Committee on Health. During the past six years of implementation, Health Canada has gained experience with the Regulations, received considerable feedback from stakeholders, and made significant progress in ensuring better public access to safe and effective natural health products.

In this section:

• Product Review Performance
• Reconsideration Process
• Food and Drug Regulations - Schedule F
• Natural Health Products Regulatory Review
• Exempted Products
• Keeping Canadians Informed

Product Review Performance

Health Canada is working to address the current natural health product licence application backlog.

Since the implementation of the Natural Health Products Regulations in January 2004 until the end of June 2010, Health Canada received 52,363 Product Licence Applications. Of this total, 41,412 (79%) applicationshave been completed and 22,820 product licences have been issued (representing 29,758 products). The remaining completed applications were either refused by Health Canada or withdrawn by the applicant.

The Department has increased its application processing speed by streamlining current practices, including:

• fast-tracking certain types of lower-risk natural health product reviews and new product monographs
• grouping applications for similar product types
• launching (on February 26, 2009) the Natural Health Products Online Solution, a new world-class electronic system which will make the licensing process more efficient
• creating the Licensed Natural Health Products Database, a database of all natural health products that have been authorized for sale in Canada

These improvements will result in a regulatory system that is efficient, effective and appropriate to the level of risk associated with natural health products.

Details on Health Canada's progress with the assessment of licence applications for natural health products are provided in Status of Submission Quarterly Reports, which are released to stakeholders every quarter.

Reconsideration Process

In January 2009, Health Canada issued its Reconsideration Process for Natural Health Products, which will help resolve licensing disputes in a fair, transparent and timely manner. This process will let companies formally ask Health Canada to reconsider any decision that resulted in a natural health product being denied authorization to be sold in Canada.

Food and Drug Regulations - Schedule F

Health Canada is carrying out scientific assessments of 11 naturally-sourced medicinal ingredients currently listed on Schedule F of the Food and Drug Regulations. As a result of these assessments, medicinal ingredients that were previously only available in Canada through prescription may in the future be available as over-the-counter natural health products.

A notice to stakeholders on this initiative was issued March 6, 2009.

Natural Health Products Regulatory Review

In March 2009, Health Canada posted the report "Final Report - Online Consultation: Natural Health Products Regulatory Review" on Health Canada's website. This review was conducted in March 2007 as part of the Department's commitment to review and refine the Natural Health Products Regulations.

The Review allowed stakeholders to provide feedback on their experiences with the Regulations. This feedback is helping Health Canada further refine and improve its regulatory framework for natural health products, while assuring that Canadians have continued access to natural health products that are safe, effective and of high quality.

Exempted Products

Because of the continuing backlog in product licence applications, Health Canada published the  Natural Health Products (Unprocessed Product Licence Applications) Regulations on August 3, 2010. These new regulations allow for the legal sale of "exempted" products which do not yet have a product licence, but which passed an initial assessment for information and safety criteria, giving Health Canada more time to evaluate them fully.

You can search for products that have been granted an exemption using the new  Exempted Products Database.

Keeping Canadians Informed

In the spirit of openness and transparency, Health Canada is committed to informing stakeholders and the public about its ongoing activities related to how natural health products are regulated.

For more information, see About Natural Health Products and About Natural Health Product Regulation in Canada.