Funding and Fees
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What is Cost Recovery?
Cost recovery is a federal government practice. Health Canada charges fees to recoup a portion, or the entirety, of costs incurred to deliver regulatory programs and ensure businesses pay their fair share. This is common practice amongst international regulators of health products. Starting April 1, 2021, all fees will be adjusted annually by the Consumer Price Index (CPI). Health Canada will consult industry on any fee adjustment beyond the scope of the annual CPI update.
Since the 1990's, Health Canada has been charging fees for certain services and activities related to the regulation of pharmaceuticals, biologic drugs, medical devices and veterinary drugs under the Food and Drugs Act (FDA).
These fees apply to activities such as pre-market regulatory review, compliance and enforcement under our inspection program, and the ongoing surveillance of products once they are on the market. For information on fees as well as relevant guidance documents and forms, please visit the links below:
Health Canada's Notice: Guidance Document Updates to Reflect New Fees and Policies for April 1, 2020 provides a list of guidance documents that have been revised to reflect the updated fees, rules and fee mitigation measures.
Small Business Mitigation
Health Canada's small business fee reduction measures minimize the impact of fees on small businesses. Businesses that qualify will receive reductions of 50% for Pre-market Evaluation fees, and reductions of 25% for Right to Sell fees as well as Establishment Licence fees will be reduced by 25%. For businesses filing their first ever Pre-market product submission in Canada, the fee will be waived. Note that this offer is only valid for companies making their first ever submission to Health Canada; all subsequent submissions will be subject to the fee reductions listed above.
For more information and to learn how to apply for a small business fee reduction, please visit the Small Business Mitigation webpages.
Please visit the Drug and Medical Device Small Business Application to apply for small business status.
Questions regarding small business mitigation should be directed to the Small Business Office at firstname.lastname@example.org.
Questions regarding fee proposals should be directed to the Cost Recovery Policy Inbox at email@example.com.
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