Guidance on biocide annual confirmation and fees for the right to sell biocides: Introduction
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Once a biocide is authorized for sale in Canada, industry must pay an annual fee to retain the right to sell the biocide in Canada. Health Canada has charged fees since 1995 to recover some of the associated costs with post-market regulatory activities such as assessing safety signals and trends and communicating about risks.
Objective
This document provides guidance on how fees for the right to sell biocides will be administered in accordance with the Food and Drugs Act and as stipulated in the Fees in Respect of Drugs and Medical Devices Order.
Policy statements
A market authorization holder will be charged a fee for the right to sell a biocide each year that the biocide is on the market in Canada. For the purposes of this document, a market authorization holder is any entity or person who holds a market authorization issued for a biocide under section 11 of the Biocides Regulations. Fees are charged for a 12-month period which begins October 1 and ends September 30 of the following year.
Unpaid fees are subject to collection procedures in accordance with the federal government's directive on public money and receivables. Health Canada has the authority to withhold services, approvals or rights and privileges for unpaid fees.
As of May 31, 2025, new fees for biocides will be in effect. See section on Applicable fees for further details. Further, as of May 31, 2025, Health Canada:
- Will offer fee mitigation in specific circumstances. Fees may be waived or reduced for small businesses, publicly funded health care institutions and those owned by federal, provincial or territorial governments. See Section on Mitigation measures for further details.
- Will charge a reduced fee in the event that a performance standard is missed. See Section on Missed performance standards for further details.
Scope and application
This guidance document applies to all biocides for which a market authorization is issued and the sale of the biocide has commenced in Canada.