Proposed fees for natural health products: Annex A, CESD report
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The Commissioner of the Environment and Sustainable Development (CESD) looked at natural health products (NHPs) and published a report with its recommendations in 2021. Health Canada committed to implementing the recommendations. To finance the changes that will result from addressing the CESD recommendations, we will be charging fees. This new fee structure will help to reduce the need for public funds.
Read the CESD 2021 report on natural health products.
Recommendation 2.26
Health Canada should obtain sufficient evidence to verify that licensed sites follow good manufacturing practices before products are released on the market and obtain information about which NHPs are available on the market.
Health Canada response
Health Canada notes its limited regulatory authorities to compel companies to provide information on quality as part of the product licence submission process. Applicants are required to provide only an attestation that their product will meet the prescribed quality requirements. To improve its pre-market quality oversight of natural health products, the department has been using information gathered through 2 compliance monitoring projects and a paper-based audit of good manufacturing practices at several manufacturing sites. The department also acknowledges that natural health products are the only line of health products for which all regulatory activities are funded by the public. The absence of a stable funding framework combined with the limited regulatory authorities for quality has placed significant pressure on the department to perform its regulatory activities and efficiently respond to the increasingly high number and scientific complexity of product submissions. In response to this recommendation, the department will: establish fully costed options for a risk-based approach to quality oversight prior to the issuance or renewal of licences and determine the full regulatory and operational implications of these options; explore mechanisms to obtain information about which products are available on the market; and take steps to propose user fees to natural health products to offset the costs of licensing and post-market activities.
Recommendation 2.47
Health Canada should develop a risk-based monitoring and inspection program that establishes the scope and frequency of inspections and that considers risks related to products, sites, and problems raised from its follow-up activities.
Health Canada response
Health Canada recognizes that natural health products are the only line of health products for which there is no ability to mandate a recall or to impose terms and conditions to mitigate safety risks associated with these products. The department has completed several compliance monitoring projects to gather information on quality oversight of natural health products and recognizes the need to expand its activities into a more robust inspection program. The department will: implement a pilot program for inspecting the good manufacturing practices of natural health products to promote and verify compliance of the natural health product industry through inspections of licence holders across Canada and take further actions on the basis of the outcome of this pilot; take steps to propose new tools to strengthen the department's ability to deter and address non-compliance, which include moving forward with a proposal to extend to natural health products the use of powers under the Protecting Canadians from Unsafe Drugs Act (Vanessa's Law); establish fully costed options for a risk-based approach to inspections; and take steps to propose the expansion of user fees to natural health products to offset the costs of post-market activities.
Recommendation 2.56
Health Canada should, in cases of products suspected of causing serious health risk, obtain the information it needs to verify and ensure that these products are not available for sale to consumers in Canada.
Health Canada response
In addition to the immediate steps Health Canada already takes to protect the health and safety of Canadians when a serious risk to health is identified, the department will: take steps to propose new tools to strengthen its ability to deter and address non-compliance, which include moving forward with a proposal to extend to natural health products the use of powers under the Protecting Canadians from Unsafe Drugs Act (Vanessa's Law); and take steps to propose the expansion of user fees to natural health products to offset the costs of licensing and post-market activities.
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