Guidance on evaluation fees for biocides: Application fees and fee categories
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Applicable fees
The applicable fees are laid out in Schedule 2.1 of the Fees in Respect of Drugs and Medical Devices Order. Fees will be adjusted once a year to keep up with inflation. The annual adjustment will be equivalent to the change in the Consumer Price Index measured in April of the previous year.
Every fall, Health Canada will publish a notice of intent in the Canada Gazette specifying the fee amounts that will take effect the following April 1. We will also update the Canada.ca web site.
The fee is based on when the application was filed. This is the date that Health Canada considers the application has been completed to our standards. The filing date and the date that we receive the application are the same if the application is accepted for preliminary examination as is, with no adjustments required.
However, the filing date will lag behind the date of receipt if we find that the application is incomplete, and the applicant needs to provide additional information. This can impact on the fee that is charged. For example, we receive an application on March 15, 2026, but adjustments are required, and the filing date is April 5, 2026. In this case, the application would be charged the fee that is in effect as of April 5.
Note: Applications are considered received on the next business day if they come in:
- after 5 pm Eastern Standard Time
- on a weekend
- on a statutory holiday
The fee structure for a biocide application review is hierarchical. Only the highest of all the possible applicable fees applies and will be charged. For example, an application for a major change with efficacy (for example, adding a claim) and a minor change (for example, removing an alternate formulation) would only be charged the fee for major change with efficacy.
Fee categories
Descriptions of each fee category are given below. For more details, please consult the Management of Biocide Applications guidance document and the Guidance on biocide application pathways and general requirements.
Full review - novel biocide application
These are applications in support of a biocide that has one or more of the following:
- A novel active ingredient or combination of active ingredients
- A novel physical form
- A novel use or purpose
- A novel method of application
Full review application
These are applications for products containing reports of tests and studies with respect to efficacy data in support of a biocide. These fees would also apply for products seeking a post-authorization change, if those applications include additional reports of tests and studies with respect to efficacy data to what had been provided to Health Canada in the original application.
There are three tiers of biocide full review, each with its own fee, depending on the amount of supporting data:
- Tier I: 25 or fewer reports of tests and studies with respect to efficacy data
- Tier II: Between 26 and 50 reports of tests and studies with respect to efficacy data
- Tier III: 51 or more reports of tests and studies with respect to efficacy data
Use of foreign decisions (UFD) application
This is an expedited pathway for applications in support of a biocide based on a comparison to a foreign biocide approved for sale by a foreign regulatory authority listed on the List of Foreign Regulatory Authorities for Biocides and meets the criteria outlined in section 26 of the Regulations.
Health Canada will provide updates as modifications are made to the list of foreign regulatory authorities for biocides.
Monograph application
These are applications for a market authorization for biocides with a use or purpose (claim), active ingredients and conditions of use that meet those outlined in the biocide monograph.
Previously, under the Food and Drug Regulations FDR, these applications would have been filed under the Labelling Standard fee category.
Comparison - labelling only application
These are applications based on comparison to another biocide supporting a change in the market authorization holder's name and brand name that requires a review of labelling material due to deviations from the comparison biocide's labelling.
A biocide applying for a market authorization through the biocide labelling only pathway can deviate from the comparison biocide in terms of:
- removal of cross-promotion
- change to the packaging material or type
- change to the net quantity of the biocide in the package
- removal of intended uses or purposes and associated directions for use
- removal of methods of application and associated directions for use
- removal of settings in which the biocide is intended to be used
- inclusion of only certain alternate formulations in the application, if the comparison product has been authorized for more than one formulation
Comparison - administrative application
These are applications for a market authorization based on comparison to an authorized biocide through a licensing agreement. This application pathway is for biocides with all aspects identical to those of the comparison biocide, except for the brand name(s) and/or applicant's name.
No other changes to the biocide from the comparison biocide, including changes to labelling material, can be made through this application pathway. Any such changes should be filed using the labelling only pathway (if applicable) or one of the major or minor change pathways.
Major change application - quality and risks
These are post-authorization applications for a notice of acceptance for a change to an authorized biocide that is reasonably expected to have a major impact on the quality of the biocide, the risks associated with the biocide or the uncertainties related to the risks, with no additional pieces of efficacy data.
Any post-authorization changes which include additional efficacy data are required to be filed as a full review, and are not eligible for this pathway. Please consult the Management of Biocide Applications guidance document for more information.
Examples include:
- Revising the directions for storage
- Removal of risk information
- Revisions to the biocide's shelf life if certain conditions are met
Major change application - monograph
These are post-authorization applications for a product initially authorized through the monograph pathway seeking a major change that is supported by the monograph (for example, adding a claim from the monograph). If you are already filing major changes through this pathway, you may also make minor changes related to product or company information. The biocide must continue to meet the monograph parameters.
Any post-authorization changes which include additional efficacy data are required to be filed as a full review, and are not eligible for this pathway. Please consult the Management of Biocide Applications guidance document for more information.
Changes acceptable through this pathway include:
- Changes that are not related to safety or quality (such as, addition of/revision to a claim from the monograph for a biocide that meets the monograph parameters) and
- Major changes to a product that impact efficacy (if initially authorized through the monograph pathway and continues to meet the monograph parameters)
Minor change notification
For this post-authorization pathway, applicants are to submit a written description of a change to an authorized biocide that reasonably has a minor impact on the quality of the biocide, the benefits or risks associated with the biocide or the uncertainties related to the benefits and risks.
Examples include:
- Addition of a brand name
- Removal of an alternate formulation
- Addition of risk information
Transition to Biocides Regulations
Biocides that are currently regulated under the FDR or PCPA may transition under the Biocides Regulations at any time up to four years following the coming-into-force date of May 31, 2025. No fee will be charged for this transition when using a transition application, and no performance standard will be associated with these applications.
However, all applicable fees for applications for a market authorization or notice of acceptance or written descriptions will continue to be charged during the transition period. Post-authorization submissions for products which have not been transitioned will be charged fees under the fee structure for drugs, while applications for transitioned products will be charged under the new fee structure for biocides.