Management of Biocide Applications: Additional resources

Definitions

Control Number (may also appear as application number)

The number assigned to applications for tracking.

Dossier

A collection of biocide product(s) under one biocide market authorization for a given market authorization holder.

Dossier Identifier (Dossier ID)

A number created by Health Canada to uniquely identify the dossier composed of a lowercase letter "q" followed by six unique digits. It is required for completing the biocide application form as well as creating the top-level folder name.

Drug

Defined in section 2 of the Food and Drug Act (FDA), a drug includes any substance or mixture of substances manufactured, sold or represented for use in

the diagnosis, treatment, mitigation or prevention of a disease, disorder, or abnormal physical state, or its symptoms, in human beings or animals,
restoring, correcting or modifying organic functions in human beings or animals, or
disinfection in premises where food is manufactured, prepared or kept.

Filing Date

Refers to the date that the application is deemed administratively complete by Health Canada. For example, the application contains all necessary forms (BAF), and the cost-recovery sections have been filled out. This date may differ from the date of original receipt should the application be considered administratively incomplete at that time.

Note: An application received after 5:00 pm Eastern Standard Time, during a weekend, or on a statutory holiday is considered to be received on the next Health Canada business day.

Market authorization holder/Applicant

For biocides, the market authorization holder/applicant is the person whose name the biocide application is filed under and, the person who holds the market authorization for a biocide issued under the regulations. The name and contact information of the market authorization holder must be included on the product label. Note that the applicant is not necessarily the company that fabricates the biocide.

Regulatory Activity

A collection of all regulatory transactions throughout the process of a specific activity such as a market authorization application or post-authorization change.

Contact us

Natural and Non-prescription Health Products Directorate (NNHPD)

For information on the pre-market authorization requirements for biocides:

E-mail: nnhpd-dpsnso@hc-sc.gc.ca

eReview within the Business Facilitation and Modernization Directorate (BFMD)

For information on filing applications electronically:

E-mail: ereview@hc-sc.gc.ca

Marketed Health Products Directorate (MHPD)

For sales-related information (first sale and discontinuance of sale):

E-mail: osip-bppi@hc-sc.gc.ca

For questions related to the biocide annual confirmation of marketing status:

E-mail: annual-biocides-annuelle@hc-sc.gc.ca

For information on post-market safety monitoring and reporting obligations:

E-mail: bbrs.rpm-gpr.bbra@hc-sc.gc.ca

Performance standards for biocide applications

Processing

All biocide applications are subject to a 10-calendar day processing period following receipt and prior to initiation of the regulatory screening of the application by NNHPD (refer to the Processing of an application section).

Eligibility for Screening 1 Period

For some application pathways below, NNHPD completes the entire assessment during the Screening 1 period. For others, we conduct a 45-calendar day preliminary screening (i.e., Screening 1) before the application is accepted into Review 1.

Application Pathway	Performance Standard (in calendar days)
Application Pathway	Screening 1 (including response to NOD)	Review 1 (including response to NOD)	Cost Recovery (CR) Review^{Footnote 1}	Screening 2 Response to NON	Review 2 Response to NON
Full Review – Novel Biocide	45	300	300	45	150
Full Review – Tier I	45	180	180	45	90
Full Review – Tier II	45	195	195	45	90
Full Review – Tier III	45	210	210	45	90
Comparison – Labelling Only	45	90	90	45	45
Comparison – Administrative	45		45	N/A	N/A
Use of Foreign Decision (UFD)	45	90	90	45	45
Monograph	60		60	N/A	N/A
Major Change - Monograph	30		30	N/A	N/A
Major Change – Quality and Risks	60		60	N/A	N/A
Minor Change	30		30	N/A	N/A
Transition^{Footnote 2}	90		N/A	N/A	N/A
Footnote 1 The cost recovery (CR) review column defines the applicable performance standard associated with each application pathway per the Performance Standards for Fees in Respect of Drugs and Medical Devices Order. For application pathways that do not enter Review 1, the CR performance standard is the period from the date of acceptance of an administratively complete application within NNHPD to the date of first decision. For application pathways with a preliminary screen (i.e., Screening 1 period) before acceptance into Review 1, the CR performance standard is the period from the date of acceptance into Review 1 to the date of first decision, not including any review clock pauses. In the event that a biocide application is not reviewed within the established CR performance standard, we will credit you 25% of the original fee. See the Guidance on evaluations fees for biocides. Return to footnote 1 referrer Footnote 2 Existing DIN holders or registrants for biocides authorized or registered under the FDR or PCPA may file a transition application or a new application during the transition period to transition their biocides to the regulations. A transition application is an abbreviated application because you do not need to include all the information required in a new application for a biocide market authorization. No fees or performance standards are associated with transition applications. The performance standard provided in this table is an estimate only. Transition applications are only active during the transition period, from May 31, 2025 to May 31, 2029 (4 years, starting at Coming into force (CIF)). Return to footnote 2 referrer

Time to Respond to a Clarification Request

The table below shows the response times according to each application pathway's performance standard.
Performance standards	Time to respond
180-300 days	15 calendar days
31-90 days	7 calendar days
0-30 days	2 calendar days

While the type of application generally guides the response time, these timelines are guidelines and NNHPD can adjust them to be longer or shorter based on the complexity of the request or circumstances of the screening or review.

For response timelines falling on a weekend or statutory holiday, we will accept the response on the next Health Canada business day.

Status requests

If you have questions about the status of your biocide application, you should contact NNHPD by e-mail at nnhpd-dpsnso@hc-sc.gc.ca.

Folder structure and document placement

Module 1 – Administrative and Product Information
Number	Title	List of Documents (not exhaustive)	Description
1.0	Correspondence	Do not include any documents in this section, documents should only be included in the subsections.	No description
1.0.1	Cover Letter	Cover Letter	Must be provided with every transaction. Refer to the application pathways and general requirements guidance for detailed information regarding the Cover Letter requirements. Do not include: Scientific information Summary response in a question-and-answer format Response to request for additional information
1.0.2	Copy of Health Canada issued correspondence	The copy of the original request issued by Health Canada, such as (but is not limited to): Request for Clarification (during processing, screening or review) Notice of Deficiency (NOD) Notice of Non-Compliance (NON) Not Satisfactory Notice (NSN) No Objection Letter (NOL) Screening Deficiency Notice (SDN) Request Letter from the Marketed Health Products Directorate (MHPD) Informal email communications	The copy of the issued request must be provided when filing any type of response. This helps Health Canada to process responses more accurately and with no delays.
1.0.3	Health Canada Solicited Information	Itemized response in a question-and-answer format	The itemized response in a question-and-answer format: should summarize the response and cross-reference the supporting data placed in the appropriate Module of the regulatory activity is in response to questions posed by any division at Health Canada should be a single document that answers all questions Do not include: Supporting data; example: revised specifications, additional stability data, Certificate of Analysis, Letter of Authorization, payment document, efficacy study data
1.0.4	Meeting Information	Any meeting related information and documentation such as: Meeting request Meeting information package¹ Brief slide presentation Sign-In Sheet Meeting minutes Written consultation request	The items listed should be provided as separate documents ¹Meeting Information package should be provided as one single file
1.0.5	Request for Reconsideration Documentation	Letter of Intent Request for Reconsideration Other Reconsideration related Information (such as presentations, background documents, draft questions)	No description
1.0.6	General Note to Reviewer	· Note to Reviewer¹	¹Notes to reviewers are not a requirement. However, applicants may choose to include them; therefore, the following guidelines are provided to promote a consistent approach to their naming and placement within the regulatory activity. A Note to Reviewer that addresses the regulatory activity as a whole should be in this section. A Note to Reviewer that is specific to a section should be filed as document in that section. For example, a Note to Reviewer that addresses the product's label text should be filed under the m1.2.1 Inner and Outer Labels heading.
1.1	Administrative Information	Do not include any documents in this section, documents should only be included in the subsections.	No description
1.1.1	Application Forms	Biocide Application Form HTML file¹ Third-Party Authorization letter (for applicable regulatory activities)²	¹Must be provided in each transaction ²Authorization to be provided within a regulatory transaction only if the party signing the regulatory activity is a third party acting on behalf of the applicant. A separate authorization is required for each regulatory activity. Refer to Third-Party Authorization template.
1.1.2	Authorization for Sharing Information	Letters of confirmation support of an application based on comparison¹ Letters authorizing a change in product ownership or merger/buyout² Certificate of amalgamation	· ¹Must attest that the comparison biocide market authorization holder has provided you with the master formula for the other biocide and mention the other biocide's brand names and identification number. · ²Must be signed by the divesting market authorization holder and must confirm that ownership of the product is being transferred from the divesting market authorization holder to the acquiring market authorization holder
1.1.3	International Information	Information on the product application, approved indications and marketing status in other countries/regions. Contextual information should be provided in this section when requested. Depending upon the application type this may include, but is not limited to, the following: International registration, review and/or marketing status, including date of filing, approval of product or post-authorization changes in other jurisdictions, information regarding the discontinuation, stop of sale and/or market recall¹ Foreign regulatory refusals Foreign review attestations Confirmation of filing with a foreign regulator or the date(s) of approval or withdrawal Foreign review reports, including Question and Answer (Q and A) documents (upon request only)¹ Meeting minutes from other jurisdictions (upon request only)¹.	¹A copy of the information received from other regulatory agencies (for example, US Environmental Protection Agency (US EPA)). For Use of Foreign Decision (UFD) applications, the following documents must be included: o US EPA Confidential Statement of Formula (CSF) for the foreign biocide o US EPA Form 8570-25 Data Matrix for the foreign biocide o US EPA Pesticide Registration Notice for the foreign biocide o evidence that the authorization for the foreign biocide has not been suspended (for example, a screen shot of the foreign biocide registration status in the US EPA Pesticide Product and Label System database)
1.1.4	Post- Authorization Information	Sales related information-First sale ^{1, 2} ^·Sales related information- Permanent Discontinuance of Sale ³ ^·Post-Authorization Commitments⁴	¹As per section 45 of the Biocides Regulations, market authorization holders are required to notify Health Canada of the date of first sale of a biocide along with further related information ² This should not be confused with the Biocide Annual Confirmation of Marketing Status, which is not included in the scope of this document. ³As per section 47 of the Biocides Regulations, market authorization holders are required to notify Health Canada of the date of permanent discontinuance of a biocide, along with further related information. ⁴Commitments may be made by applicants to provide additional information to Health Canada in order to further support the approved regulatory activity, and when terms and conditions have been imposed on a market authorization. Some examples include (but are not limited to) the following: additional stability data; additional efficacy data; additional safety data You should track regulatory activities with post-authorization commitments by including the following table in section 1.1.4 Post-Authorization Information. Summary of Commitment Date of No Objection Letter/ Notice of Acceptance Control # Date Outstanding Information Provided Date of commitment closure by Health Canada Once the commitment has been closed off by Health Canada, it should remain in the table for at least one subsequent regulatory activity, after which it can be removed. If there are no open commitments, a statement confirming there are no outstanding commitments should be provided.
1.2	Product Information	Do not include any documents in this section, documents should only be included in the subsections.	No description
1.2.1	Inner and Outer Labels	Inner and outer labels Package inserts Any supplementary information on the use of the biocide that is to be provided to users on request (e.g. Technical Data Sheet)	Include the proposed label text When seeking label amendments, both an annotated version and a clean version of the revised label text should be placed in this section.
1.2.2	Non-Canadian Labelling	Copy of approved labelling from other regulatory jurisdictions.	If the biocide has been marketed outside Canada, you should supply the label and package inserts approved in other jurisdictions, clearly identifying them by country or region. For Use of Foreign Decision (UFD) applications, the following documents must be included: US EPA Approved Label text for the foreign biocide.
1.2.3	Comparison Product Labelling	Comparison product labels (for licensing agreements)	If the biocide is cross-referencing another Health Canada-approved label, you should supply the label and package inserts approved for the parent product. This is not a requirement but may facilitate the review.

Module 2 – Efficacy Information
Number	Title	List of Documents (not exhaustive)	Description
2.0	Efficacy	Do not include any documents in this section, documents should only be included in the subsections.	No description
2.0.1	Efficacy Summary	A summary of the biocide's efficacy when used in accordance with the conditions of use	This summary is intended to provide an overview of the efficacy data submitted, and not to address all of the information captured within an efficacy data report. We recommend that you summarize the information in a table. The efficacy summary should include descriptions of the formulated test product, the product's intended general uses or purposes, the product's intended specific efficacy claims and of the submitted efficacy data used to support each of these claims, etc. The efficacy summary should include descriptions of confirmatory testing, if applicable, and the purpose for conducting this testing (e.g., formulation changes, contact time changes, etc.).
2.0.2	Disinfection - Bacteria	Complete efficacy test reports to support disinfection claims against bacteria	No description
2.0.3	Disinfection - Fungi	Complete efficacy test reports to support disinfection claims against fungi	No description
2.0.4	Disinfection - Viruses	Complete efficacy test reports to support disinfection claims against viruses	No description
2.0.5	Disinfection - Mycobacteria	Complete efficacy test reports to support disinfection claims against mycobacteria	No description
2.0.6	Disinfection - Spores	Complete efficacy test reports to support disinfection claims against spores	No description
2.0.7	Non-food contact sanitization	Complete efficacy test reports to support sanitization claims on non-food contact surfaces	No description
2.0.8	Food contact sanitization	Complete efficacy test reports to support sanitization claims on food contact surfaces	No description
2.0.9	Supplemental Efficacy Information	Wetness tests Scientific rationales	Documents other than those listed in folders 2.0.1 – 2.0.8, that provide additional evidence to support the biocide's efficacy.
2.1	Confirmatory Efficacy	Do not include any documents in this section, documents should only be included in the subsections.	No description
2.1.1	Disinfection - Bacteria	Complete efficacy test reports to support disinfection claims against bacteria	No description
2.1.2	Disinfection - Fungi	Complete efficacy test reports to support disinfection claims against fungi	No description
2.1.3	Disinfection - Viruses	Complete efficacy test reports to support disinfection claims against viruses	No description
2.1.4	Disinfection - Mycobacteria	Complete efficacy test reports to support disinfection claims against mycobacteria	No description
2.1.5	Disinfection - Spores	Complete efficacy test reports to support disinfection claims against spores	No description
2.1.6	Non-food contact sanitization	Complete efficacy test reports to support sanitization claims on non-food contact surfaces	No description
2.1.7	Food contact sanitization	Complete efficacy test reports to support sanitization claims on food contact surfaces	No description
2.1.8	Supplemental Efficacy Information	Wetness tests Scientific rationales	Documents other than those listed in folders 2.1.1 – 2.1.7, that provide additional evidence to support the biocide's efficacy.

Module 3 – Safety Information
Number	Title	List of Documents (not exhaustive)	Description
3.0	Safety	Do not include any documents in this section, documents should only be included in the subsections.	No description
3.1	Safety Summary	A summary of the biocide's safety when used in accordance with the conditions of use	The safety summary should include the: residue information, hazard profile and classification system being used, potential safety hazards and toxicity end points, proposed precautionary and hazard statements, etc.
3.2	Safety Data Sheets	safety data sheet for the end-use biocide safety data sheet(s) for the active ingredient and/or formulants	The SDS should include: end-point toxicities information on the biocide's safety profile physical and chemical properties and hazards (such as pH, boiling point, flammability, flash point, flame projection)
3.3	Acute Toxicity Studies	Acute Oral Toxicity Acute Dermal Toxicity Acute Inhalation Toxicity Acute Dermal Irritation/Corrosion Acute Eye Irritation/Corrosion Skin Sensitization	This is referred to as the acute "6-pack" studies. Complete test reports should be submitted, based on the short-term exposure endpoints test protocols.
3.4	Chronic Toxicity Studies	Genotoxicity Carcinogenicity Reproductive/developmental toxicity Metabolism (metabolic impacts) and pharmacokinetics, etc.	No description
3.5	Supplemental Safety Information	Scientific literature Wavers for toxicity testing Scientific rationales	Documents other than those listed in folders 3.1-3.4, that provide additional evidence to support the biocide's hazard profile and safety hazard labelling.

Module 4 – Quality Information
Number	Title	List of Documents (not exhaustive)	Description
4.0	Quality	Do not include any documents in this section, documents should only be included in the subsections.	No description
4.1	Quality Summary	A summary of the biocide's quality when used in accordance with the conditions of use	The summary should summarize your biocide's specifications and stability/shelf-life results. The following additional information may also be required in the summary, as applicable (for example, for novel biocides and sterile products): a detailed description of the manufacturing process and controls, a list/concentration/analysis of residues, degradation products and substances of concerns, a summary of factors that could affect the stability of the product, etc.
4.2	Product Specifications	Documents including statements of all properties and qualities of the biocide and its ingredients, test methods, and tolerance limits	The product specifications should describe the: physical and chemical properties of your biocide and its' ingredients, formulation (including purity, potency, ingredient information, etc.), and test methods and tolerance limits.
4.3	Stability Studies	Stability testing reports to support the biocide's proposed shelf life	No description
4.4	Sterile Biocide Information	Document containing additional requirements for biocides that are sterile	This additional information should include validation of the sterilization technique, a detailed description of the sterilization process used in manufacture, scientific justification for the sterilization method used, etc.
4.5	Supplemental Quality Information	Scientific Literature Scientific Rationales Additional quality and/or stability testing	Documents other than those listed in folders 4.1-4.4, that provide additional evidence to support the biocide's quality.

Module 5 – Post-Market Safety Information
Number	Title	List of Documents (not exhaustive)	Description
5.0	Post-Market Safety Information	Do not include any documents in this section, documents should only be included in the subsections.	No description
5.1	Significant Safety Issue	· Notification of Significant Safety Issue	No description
5.1.1	Compiled safety information	· Notable incidents, serious incidents, serious unexpected incidents and other safety information that you gathered as part of your safety monitoring activities Documentation of measures taken outside of Canada to address significant safety issues Documentation of review activities, including your findings Safety monitoring systems and procedures	No description
5.1.2	Supplemental safety information	· Study reports	No description
5.2	Issue-related report	· Issue-related report	No description
5.2.1	Supplemental Issue-Related Report information	Cumulative safety reviews Reports of post-marketing experience Results from post-authorization studies	No description
5.3	Assessment Order	Response to Assessment order	No description
5.4	Test and Studies Order	Response to Test and Studies order	No description
5.5	Terms and Conditions	Response to Terms and Conditions commitment	No description
5.6	Supplemental Post-Market Safety Information	Scientific literature Individual safety reports Proposals for discontinuation of continued monitoring strategies Plans for risk mitigation activities in other jurisdictions Request to amend T&Cs	Documents other than those listed in folders 5.1-5.5 that provide additional evidence to support the biocide's post-market safety profile
5.7	Advertising	Advertising Complaint Request for information	No description
5.8	Risk Communications	Dear Health Care Professional Letter Dissemination lists Proposed dissemination strategy Risk Communication Document/Final Risk Communication Document	No description

Third-party authorization template

Section A: Authorization

Market authorization holder contact's first and last name:

Third-party individual:

Third-party company name:

Primary brand name of product:

Market authorization holder name:

☐ By checking this box, I authorize the third-party individual to file a regulatory activity for
this product on behalf of the market authorization holder.

Section B: Signature

First and last name:

Title: