Natural health product regulation in Canada: Natural health product cost recovery
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Introducing natural health product (NHP) cost recovery
Health Canada currently relies solely on public funding to fund regulatory services it provides to industry. Regulatory services for other health products are funded through a mix of revenues from fees and public funding.
Health Canada proposed fees for industry to strengthen the NHP program and support its long-term sustainability. The Department’s current focus is on advancing the policy and regulatory changes set out in Health Canada and the Public Health Agency of Canada’s report on red tape reduction which is focused on burden reduction and finding operational efficiencies. We will revisit the cost recovery proposal once the program adjustments have been made as these will impact the NHP program costing model.
Proposed fees for natural health products
On May 12, 2023, Health Canada published its Proposed fees for natural health products.
The proposed fees fell into 3 categories:
- pre-market evaluation
- for the assessment of new products entering the Canadian market, or amendments to existing products
- site licences
- for the assessment of facilities that manufacture, import, label and package natural health products
- right to sell
- for the ability to sell a product or products in Canada
Health Canada undertook public consultations on its fee proposal between May 12 – August 10, 2023, as part of its ongoing commitment to consultation and transparency.
Informed by these consultations, Health Canada made significant revisions to the proposed fees and on March 27, 2024, published these revisions. The revised fees:
- are based on feedback received during consultations with stakeholders
- focus on recovering costs for existing program activities, including costs for the inspection program as it currently exists
- include new costs for the administration of the fee regime
The revisions to the proposed fees will allow the department to continue to:
- advance the program's ability to provide a reliable, risk-based approach to oversight of NHPs for industry
- promote access to safe and effective NHPs for people in Canada
Health Canada provided a comment period from March 27 to May 25, 2024. The input will be considered before the fees for NHPs become final. Final fees will be published in the Canada Gazette, Part II before implementation.