Guidance on evaluation fees for biocides: Invoicing, fee payment and mitigation measures

On this page

• Fee section template
• Fee payment schedule
• Mitigation measures
• Credit for missed performance standard

Fee section template

Applicants must complete the fee section of the Biocides Application Form (BAF) template. Please consult the BAF user guide for more information. Be sure this is included in your application.

The BAF outlines the fees and includes sections on fee mitigation measures. When filing your submission, do not include payment.

When Health Canada receives the required documents, we will conduct a preliminary examination. We will verify and adjust the fee if required and issue an invoice.

For most applications, we will issue an invoice when the application is accepted into the Review 1 stage. However, for applications that do not enter Review 1 (applications filed under comparison - administrative, monograph, or any major and minor changes), we will issue an invoice when we make our final decision. Payment is due 30 days from the date of the invoice.

If we reject an application during the preliminary examination period (the application is considered deficient at the time of screening), we will issue a Screening Deficiency Notice. We will also issue an invoice for 10% of the applicable fee at this time.

If an application is withdrawn after a Screening Deficiency Notice has been issued, we will issue an acknowledgement of cancellation. We will also issue an invoice of 10% of the applicable fee.

The full fee will be invoiced if an application is withdrawn after we have either:

• issued a Screening Acceptance Letter or
• reached a decision on an application filed under comparison - administrative, monograph, or any major and minor change

Fee payment schedule

The following fee payment schedule applies:

• 0% before acceptance into review and no Screening Deficiency Notice has been issued
• 10% before acceptance into review but after a Screening Deficiency Notice has been issued
• 100% after a decision is made to issue a screening acceptance letter, or a final review decision is made for an application filed under comparison - administrative, monograph, or any major and minor change

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 payable to the "Receiver General for Canada."

Mitigation measures

Requests can be made to waive or reduce fees for 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

Applicants must apply for mitigation when they file by indicating the type of mitigation being requested in the fee section of the BAF template.

Small business

The small business mitigation approach to drugs and medical devices is being maintained for biocides to align cost recovery practices across health products.

Applicants will be required to register as a small business and ensure that their registration information is up to date. Applicants already registered as a small business for drugs and/or medical devices will not be required to re-register.

Applicants who meet the criteria of a small business will be invoiced at the reduced fee (see below). However, if we determine that the applicant does not qualify as a small business, then the full fee will be due. In this case, we will issue an additional invoice for the difference between the full fee payable and the original invoice. For an application that was reviewed for free, we will issue an invoice for the full amount.

A small business is any business, including its affiliates, that has:

• fewer than 100 employees or
• 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.

Applicants must indicate on the BAF template that they are requesting small business mitigation. They must also indicate if this is their first application ever filed under the Regulations or the Food and Drug Regulations (FDR).

Types of mitigation

Applicants that meet the above definition are eligible for:

• A 50% reduction on all biocide applications;
• A "one-time only" waiving of fees for their very first application for any human or veterinary drug or biocides product filed with Health Canada.

Applicants who have previously filed a disinfectant submission under the Food and Drug Regulations are not eligible to receive a free biocide application.

If a first application is withdrawn before the final decision is made or receives a negative decision, it is still considered to be the first filed application. This means that future applications will not be reviewed for free.

Applying for small business status

Before submitting an application, applicants must first apply for small business status through the Drug and Medical Device Small Business Application process. Those who have not been granted small business status at the time of filing will be charged the full fee.

When registering, please provide the following information:

• name of company
• annual gross revenue for last completed fiscal year
• number of full-time or equivalent employees for last completed fiscal year
• previous fiscal year-end date
• affiliate status
• breakdown of the above information for each affiliated company
• contact information for all companies listed

Affiliated companies are those that:

• are controlled by the applicant's company, which holds 50% or more of the affiliate's votes or shares
• control the applicant's company, where the affiliate holds 50% or more of the applicant's company's votes or shares
• share a parent company with the applicant, where they are controlled by the same company that controls the applicant'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 applicant's fiscal year-end date has passed to verify their small business status.

At any time, Health Canada may ask the applicant 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 or management organization charts
• other official documents issued or certified by a business registration authority

Publicly funded health care institutions

Fees will be waived for all biocide applications filed by publicly funded health care institutions.

A publicly funded institution is an institution that is funded by the Government of Canada or a provincial/territorial government and is either:

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

Government organizations

Fees will be waived for applications filed by a branch or agency of the Government of Canada or of a province/territory. For example, the Department of National Defence or the Public Health Agency of Canada will not have to pay fees.

Credit for missed performance standard

Performance for all applications will be tracked individually.

The Performance Standards for Fees in Respect of Drugs and Medical Devices Order defines the applicable standard for each activity and fee. Most standards reflect the time to complete Review 1, Iteration 1, which is "the period from date of acceptance to date of first decision", not including any review clock pauses.

In the event that the review clock has been paused, the duration of the pause will be deducted from the total review time when calculating performance. In other words, the days during which the clock is paused will not count when measuring performance. Please see the Management of Biocide Applications guidance document for more information on pausing the clock during the review period.

If an application is not reviewed within the established performance standard, applicants will be credited 25% of the fee originally paid. Health Canada will credit the applicant's account within 30 days.

For an application filed under comparison - administrative, monograph, or any major and minor change, the 25% credit will be applied automatically to the invoice. In other words, an invoice will be issued for 75% of the applicable fee.