Currently in Canada, there are no Health Canada fees charged in relation to Natural Health Products (NHPs). In May 2023, Health Canada proposed implementing cost recovery fees to enhance regulatory oversight and streamline the approval processes for NHPs. The proposed fees are designed to offset the expenses associated with product evaluations, assessments, and ongoing monitoring, which fall under Health Canada’s regulatory purview.
The proposed fees mimic those currently in place for drugs and medical devices sold in Canada and will apply to product licence owners, manufacturers, packagers, labellers and importers of NHPs in Canada. The proposed NHP fees and performance standards can be found here. Industry will also be required to pay an annual fee for the right to sell NHPs in Canada, which is proposed as $542 per NPN.
The introduction of cost recovery fees has raised huge concerns within the industry. Manufacturers and brand owners argue that the fees could be financially burdensome, particularly for small businesses. Health Canada is proposing small business fee reduction measures to minimize the impact of fees on small businesses. However, industry fears that the additional costs may impede innovation and limit consumer access to NHPs due to price hikes.
Health Canada expects the newly proposed fee structure to become effective on April 1, 2025. The proposal is open for consultation until August 10, 2023. We strongly advise individuals or organizations working with NHPs in Canada to promptly offer feedback and express any concerns they may have regarding the fee proposal through an online comment form.
If you would like to know more about the proposed fee structure, how it may impact your business, whether you are eligible for the small business fee reduction, and more, please contact us.
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