Guidance on biocide annual confirmation and fees for the right to sell biocides: Guidance

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• Regulatory requirements
• Invoicing and fee payment
• Mitigation measures
• Missed performance standards
• Applicable Fees
• Transition to Biocides Regulations

This section provides detailed information on regulatory requirements, invoicing and fee payment, mitigation measures, missed performance standards, and applicable fees.

Regulatory requirements

Once an applicant has been issued a market authorization by Health Canada, the biocide is considered to be authorized for sale in Canada. However, market authorization holders must submit a complete Biocide Application Form (BAF) within 30 days after commencing sale of the biocide in Canada. For more information on how to fill out the First Sale part of the Sales-Related Information section in the BAF, please consult the BAF user guide.

Annual notification

Before October 1 of each year, biocide market authorization holders must confirm whether they are selling the biocide in Canada or have sold it in Canada in the 12 months preceding that date. In June of every year, Health Canada sends each market authorization holder the following information:

• A Biocide Annual Confirmation of Marketing Status, listing biocides with a market authorization and their respective identification numbers that, according to Health Canada records as of the date of printing, have been authorized for sale in Canada
• Instructions on how to complete the annual confirmation
• Instructions on how to apply for small business fee mitigation
• Any other information deemed necessary

Market authorization holders should submit the completed Biocide Annual Confirmation of Marketing Status and any other applicable documents by mid-August to allow Health Canada sufficient time to update information in its regulatory and financial databases prior to issuing invoices on October 1st.

Note that payment is only due upon receipt of an invoice. See section on Invoicing and fee payment for further details.

Permanent discontinuance of sale

Products deemed discontinued as of October 1, resulting from a permanent discontinuance of sale, will not be subject to Right to Sell fees. If the sale of a product has been permanently discontinued and Health Canada has not been informed before October 1, the market authorization holder is still liable for payment of the right to sell fee. For more information on how to fill out the Permanence Discontinuance of Sale part of the Sales-Related Information section in the BAF, please refer to the BAF user guide.

Invoicing and fee payment

Every October 1, Health Canada sends invoices for the upcoming year based on the information market authorization holders have provided in the Biocide Annual Confirmation of Marketing Status. The person on record as holding the market authorization when the invoice is issued is responsible for payment. The invoice and any subsequent monthly statements list the market authorization holder, and they are sent to the regulatory affairs section of the company or address identified as the billing address for the market authorization holder on the returned Biocide Annual Confirmation of Marketing Status. Payment is due 30 days from date of issuance.

Instructions on the payment of fees are further outlined in the document How to Pay Health Canada Fees. All payments must be in Canadian funds. Cheques must be made payable to the "Receiver General for Canada".

Mitigation measures

Biocide right to sell fees can be requested to be waived or reduced for submissions or applications filed by:

• a small business
• a publicly funded health care institution
• any branch or agency of the Government of Canada or of a province or territory

To be considered for mitigation, market authorization holders must apply by indicating the type of mitigation requested on the Biocide Annual Confirmation of Marketing Status. In the case of small businesses, market authorization holders will be required to register as a small business and ensure that their registration information is kept up to date.

Small business

Market authorization holders who meet the criteria of a small business will be invoiced at the reduced fees described below. However, should Health Canada subsequently determine that the market authorization holder does not qualify as a small business, the full fee is then due. Therefore, an additional invoice will be issued for the difference between the full fee payable and the original invoice.

A small business is defined as any business, including its affiliates that:

• has fewer than 100 employees OR
• has between $30,000 and $5 million (CAD) in annual gross revenues

Note that the definition is an OR statement so you must meet one of the 2 qualifications. The annual gross revenues must also include all revenues and are not limited to the biocides being authorized for sale.

Market authorization holders that meet the above definition are eligible for a 25% reduction of the applicable right to sell a biocide fee.

Every year, market authorization holders must indicate that they are requesting small business mitigation on the Biocide Annual Confirmation of Marketing Status. Market authorization holders who have not registered as a small business will be charged the full fee. Market authorization holders must provide the following information when registering as a small business prior to submitting a Biocide Annual Confirmation of Marketing Status:

• Annual gross revenue for their last completed fiscal year
• Number of full-time or equivalent employees for their last completed fiscal year
• Fiscal year end date
• Breakdown of the above information for each affiliated company
• Contact information for all companies listed

Affiliated companies are those that:

• Are controlled by the market authorization holder's company whereby the market authorization holder's company holds 50% or more of the affiliate's votes or shares
• Control the market authorization holder's company whereby the affiliate holds 50% or more of the market authorization holder's company's votes or shares
• Share a parent company with the market authorization holder's whereby they are controlled by the same company that controls the market authorization holder's company

A company that has not yet completed a full fiscal year may estimate or project their annual gross revenue and number of employees. In these cases, Health Canada will follow up once the market authorization holder's fiscal year-end date has passed to verify their small business status.

At any time, Health Canada may ask the market authorization holder for additional information in order to verify their small business status. Information may include:

• Records that identify the number of persons employed for the previous fiscal year
• Financial statements
• Tax returns
• Corporate and/or management organization charts
• Other official documents issued or certified by a business registration authority

More information on small business mitigation can be found here.

Publicly funded health care institutions

Biocides right to sell fees will be waived for all publicly funded health care institutions.

A publicly funding institution is defined as an institution that is funded by the Government of Canada or a provincial government, and is:

1. licensed, approved or designated by a province in accordance with the laws of the province to provide care or treatment to persons or animals suffering from any form of disease or illness; or
2. owned or operated by the Government of Canada or a province and/or territory and provides health services.

Government organizations

Right to sell fees will be waived for branches or agencies of the Government of Canada or of a province or territory. For example, the Department of National Defence or the Public Health Agency of Canada will not have to pay a right to sell fee.

Missed performance standards

Performance for processing the Biocide Annual Confirmation of Marketing Status is tracked individually. In the event that Health Canada's Biocides Tracking System is not updated within 20 calendar days following receipt of a complete Biocide Annual Confirmation of Marketing Status, a 25% credit will be reflected on the invoice issued to the market authorization holder.

Applicable Fees

The biocide right to sell fee is an annual fee for the right to maintain a biocide product on the Canadian market. The applicable fee is given in section 58.1 (1) of the Fees in Respect of Drugs and Medical Devices Order. The fee is payable by the market authorization holder if they have sold the biocide in the 12 months preceding October 1. Beginning on April 1, 2026, fees will increase annually to keep up with inflation by an amount equivalent to the Consumer Price Index from the previous year. Health Canada will publish a Notice of Intent in Canada Gazette every fall specifying the fee amounts that will take effect the following April 1. Health Canada's web site will be updated accordingly.

Transition to Biocides Regulations

Products that are currently regulated under the Food and Drug Regulations (FDR) or Pest Control Products Act (PCPA) may transition to the Biocides Regulations at any time up to four years following the coming-into-force date (by May 31, 2029).

Food and Drug Regulations

All applicable fees will continue to be charged during the transition period. A disinfectant with a Drug Identification Number (DIN) assigned under the FDR will continue to be charged a Drug Right to Sell - Disinfectant fee until it is transitioned to the Biocides Regulations, at which point it will be charged the Biocides Right to Sell fee.

On June 1, 2029, the day following the transition period, all DINs for disinfectants that have not transitioned to the Biocides Regulations will be canceled.

Pest Control Products Act

A pest control product with both surface sanitizer and pesticide-related claims will continue to be subject to the annual charge during the transition period until it is transitioned to the Biocides Regulations. Following transition to the Biocides Regulations, it will be charged the Biocides Right to Sell fee.

Once transferred to the Biocides Regulations, or otherwise at the end of the transition period (on June 1, 2029), registered surface sanitizers with no remaining pesticide-related claims will be discontinued under the Pest Control Products Act, and will no longer be subject to the Pest Control Products Act.