Guidance on Management of Biocide Applications: Overview

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• Purpose
• Biocide application pathways

Purpose

This guidance outlines how the Natural and Non-prescription Health Products Directorate (NNHPD) manages biocide applications submitted in accordance with the Food and Drugs Act (FDA) and the Biocides Regulations (also referred to as the Regulations in this guidance). This guidance document also outlines the responsibilities and expectations of biocide applicants throughout the application process.

This guidance is intended to aid applicants in navigating the biocide application process and should be used in conjunction with associated guidance documents linked throughout this document.

This guidance is also available in PDF format upon request. To receive a copy, contact NNHPD at nnhpd-dpsnso@hc-sc.gc.ca with 'Guidance on Management of Biocide Applications' in the subject line.

For information on the regulatory frameworks and application pathways for products that are not in the scope of the Regulations such as cleaners, medical devices and pest control products, refer to the general information on different product classes section of the guidance on biocides introduction.

Post-market vigilance monitoring submissions

Note: Post-market vigilance monitoring submissions are not within the scope of this guidance. These include, for example:

• Advertising ad-hoc post-market requests
• Issue-related reports
• Notification of significant safety issues
• Post-authorization commitments
• Risk communications

If you have any questions specific to post-market vigilance monitoring, please contact the Marketed Health Products Directorate's Regulatory Project Management Office at bbrs.rpm-gpr.bbra@hc-sc.gc.ca.

Biocide application pathways

This guidance applies to all biocide market authorization and post-authorization application pathways available through the Regulations. There are ten different biocide application pathways, each described below.

Full review application (Tier I, Tier II, Tier III)

A biocide full review application includes evidence to support the safety, efficacy and quality of the biocide when used in accordance with its conditions of use and requires a scientific review.

Full review – novel biocide application

A full review - novel biocide application is for biocides that contain a novel active ingredient, a novel combination of active ingredients, or a novel use or purpose (claim), physical form, or method of application. Additional information is required within a novel biocide application compared to a biocide full review application.

Monograph application

A biocide monograph application is for biocides with a use or purpose (claim), active ingredients and conditions of use that meet those outlined in a biocide monograph. This application pathway requires supporting information for aspects of the biocide that are outside the parameters of the monograph.

Comparison - administrative application

A biocide comparison - administrative application is a type of application based on comparison to an authorized biocide. This application pathway is for biocides with all aspects identical to those of the comparison product, except for the brand name(s) and/or applicant's name.

Comparison - labelling only application

A biocide comparison - labelling only application is a type of application based on comparison to an authorized biocide. This application pathway is for biocides that require an assessment of their labelling as part of their application due to acceptable differences in labelling from the comparison biocide.

Use of foreign decisions (UFD) application

A biocide UFD application is a type of application based on comparison to a biocide that is authorized for sale by a foreign regulatory authority. The biocide and application must meet the criteria outlined in section 26 of the Regulations to be eligible through this pathway.

Major change – monograph

A biocide major change – monograph application is for biocides initially authorized through the monograph pathway that have major changes which are within the parameters of the monograph that do not impact their quality, or risks. An updated market authorization is needed prior to selling a biocide when making a major change.

Major change application – quality and risks

A biocide major change – quality and risks application is for biocides that have major changes to the quality and risk information previously provided to Health Canada relating to the biocide. Scientific information is needed to support the major change application. An updated market authorization is needed prior to selling a biocide when making a major change. Changes that impact efficacy data are not permitted through this pathway.

Minor change notification

A biocide minor change notification is used when there are minor changes to the information provided to Health Canada relating to a biocide. No data are needed to support the change.

Transition application

A biocide transition application is used to transition existing biocides to the Regulations. The transitioning biocide must remain identical to the product authorized or registered under the Food and Drugs Regulations (FDR) or the Pest Control Products Act (PCPA), except the brand name. Transitioning sanitizers registered under the PCPA also require changes to their product label(s) to comply with the Regulations. No fees or performance standards are associated with a transition application.

For more information on these application pathways, see the guidance on biocides application pathways and general requirements and the biocides post-authorization changes guidance.

For information on how to transition disinfectants authorized under the FDR, sanitizers subject to the PCPA and surface sanitizers for use in food premises subject to the FDA, see the transition of disinfectant and sanitizers to the Biocides Regulations guidance.

Note that existing drug identification number (DIN) holders seeking to file applications to change their authorized disinfectant in accordance with the FDR during the 4-year transition period should consult the management of drug submissions and applications guidance.

For existing registrants intending to submit applications under the PCPR (Pest Control Products Regulations) to amend the registration of their surface sanitizer during the 4-year transition, refer to the Pest Management Regulatory Agency's Category C Application Guidance Document for further details, or contact the PMRA at pmra.info-arla@hc-sc.gc.ca.