Management of Biocide Applications: Pre-submission information

On this page

• Guidance and policy documents
• Product classification
• Verification of a biocide's ingredients
• Filing of information to Health Canada
• Pre-submission advice meeting requests
• Meeting requests
• Meeting packages
• Post-meeting requirements

Guidance and policy documents

Health Canada has developed comprehensive guidance and policies to assist you in preparing your biocide application. These documents are meant to be read in conjunction with the management of biocide applications guidance.

These guidance documents include:

• Guidance on biocides introduction (provides definitions for commonly used vocabulary)
• Application pathways and general requirements
• Labelling requirements
• Safety requirements
• Efficacy requirements
• Quality requirements
• Biocide application form user guide
• Post-authorization changes
• Biocide evaluation fees
• Safety monitoring and reporting requirements
• Drug, natural health product, and biocide recall guide
• Transition of disinfectants and surface sanitizers to the biocides framework

Further guidance about electronic filing requirements is linked throughout this document.

Product classification

We recommend applicants consult the list of product classifications to verify whether their proposed product is classified as biocide. If you are unsure if a proposed product would be regulated as a biocide in accordance with the Regulations, we invite you to submit a classification request by e-mail at nnhpd-dpsnso@hc-sc.gc.ca. Further guidance on product classification requests is available in the guidance on biocides introduction.

Verification of a biocide's ingredients

Before submitting a biocide application, we recommend that you verify that the ingredients in the proposed product are appropriate for inclusion in a biocide. Ingredients can be verified in the Biocides Ingredients Database (BID), which is a regularly updated repository of active ingredients and formulants for use in biocides.

Note that a biocide's ingredients do not need to be listed in the database before filing an application, except for applications filed through the monograph pathway.

Inclusion of an ingredient and corresponding purpose in the database does not mean that it is safe or effective or guaranteed to be approved for use in a biocide. Depending on the application pathway, you are required to submit evidence to us to support the safety, efficacy and quality of the biocide. This review includes determining whether the ingredients (both active and formulants) meet the requirements for a market authorization to be issued.

Before filing an application, you should verify compliance of substances in the proposed biocide with the Canadian Environmental Protection Act, 1999 (CEPA 1999).

For further guidance on the BID, and compliance with CEPA 1999, consult the application pathways and general requirements guidance.

If an ingredient is not listed in the BID, and/or you are unsure if an ingredient is appropriate for inclusion in a biocide, we invite you to submit an ingredient inquiry by e-mail at nnhpd-dpsnso@hc-sc.gc.ca.

To request the addition of a new ingredient or modifications to the information found in the BID, email us at ingredient_support@hc-sc.gc.ca with a completed change request form. You must include at least 1 piece of supporting evidence in your request.

Filing of information to Health Canada

Before submitting a biocide application, you will need to understand the electronic filing requirements. You should ensure that your application contains the information needed to satisfy the regulatory requirements of the Regulations. You should also be aware that Health Canada charges evaluation fees for biocide applications. These fees vary across application pathways. For more details on the applicable fees, refer to the evaluation fees for biocides.

For sales related information such as first sale, permanent discontinuance of sale, and the biocide annual confirmation of marketing status, consult the biocide application form user guide.

The following sections outline the electronic filing requirements and provide additional resources to help you to prepare and file information to Health Canada.

For more information on the required application contents of each application pathway, refer to the Guidance on application pathways and general requirements.

Company ID

If it is your company's first time submitting an application to Health Canada, you will need to complete company enrolment and obtain a "company Identifier (ID)" by using the Company (CO) template.

Once we process your Company ID request, we will assign your company a unique 5-digit number. This assigned number must be used to submit all biocide applications and will be required for completing the Biocide Application Form (BAF).

If you have previously submitted an application to Health Canada, you already have a valid Company ID and it must be used to submit your biocide application. Should any of the information provided on the company file change in the future (for example, company address or contact information), you must complete a company amendment by updating the latest CO file.

The company enrolment/amendment process and the information collected using the CO template are managed independently from the biocide applications filed for review. It can take up to one week to obtain your company ID or amend your company data once you have provided all the necessary information.

For more information on the company enrolment and amendment process, refer to the Guidance Document The Regulatory Enrolment Process (REP): Drugs for Human/ Veterinary Use, disinfectants and biocides.

For information on processing company information, contact the Client Information Unit at client.information@hc-sc.gc.ca.

Dossier ID

A dossier is a collection of biocide product(s) under one biocide market authorization for a given market authorization holder. The dossier Identifier (ID) is assigned by Health Canada to uniquely identify the dossier.

Before submitting your first application for your biocide, you will need to request a Dossier ID.

Once we process your Dossier ID request, we will assign a dossier ID that includes a lowercase letter "q" followed by six unique numbers, which will be required for completing the Biocide Application Form (BAF).

Format for filing an application

The non-eCTD Format is the mandatory format for filing a biocide application. All applications that are filed and any subsequent information submitted (solicited and unsolicited) should be prepared using the requirements provided in the Guidance Document – Preparation of Regulatory Activities in Non-eCTD Format. For more information on the folder structure for biocide applications, refer to the folder structure and document placement section.

A biocide application is considered a regulatory activity, and any information package that you send to us as part of this application is referred to as a regulatory transaction.

Folder structure and Document Placement

Documents must be organized and placed within a specific folder structure to file a biocide application. To facilitate their application preparation, applicants can download a zip file of the folder structure for biocides and place their files in the appropriate subfolders.

The tables in the folder structure and document placement section contain the list of modules and section/subfolders, along with the list of possible documents that must be placed in the sections/subfolders when provided as part of regulatory transaction to Health Canada.

Biocide Application Form (BAF)

A biocide application form (BAF) must be completed and submitted for all biocide applications filed and any subsequent information submitted (solicited and unsolicited). The BAF collects information related to the biocide and includes relevant attestations for each application type.

For more information on how to fill out the BAF, refer to the biocide application form user guide. If you require help filling out the BAF, submit questions by e-mail to nnhpd-dpsnso@hc-sc.gc.ca.

If the contact for the regulatory activity is a third party acting on behalf of the market authorization holder, then a third-party authorization letter is required (refer to the Third-Party Authorization Template).

Cover letter

All applications that are filed and any subsequent information submitted (solicited and unsolicited) must be accompanied by a cover letter that indicates the reason for filing the information, the application pathway being used, and the date filed. You should provide a new cover letter for each transaction to ensure that the application and subsequent information are appropriately processed.

Validation of the non-eCTD transaction

Before filing your biocide application, you should understand the validation rules to provide a valid electronic transaction. For more information on the validation of the non-eCTD transaction, refer to the Validation Rules for regulatory transactions in non-eCTD format.

Method of transmission

All biocide applications must be submitted through the Electronic Submissions Gateway (ESG).

If you require help with setting up a new ESG account, submit your questions by e-mail to ereview@hc-sc.gc.ca.

Pre-submission advice and meeting requests

You may request pre-submission advice prior to filing a biocide application, by e-mail at nnhpd-dpsnso@hc-sc.gc.ca.

Your request will be triaged and assigned for response. For routine inquiries, we aim to respond within 15-calendar days; however, technical inquiries may require consultation with one or more subject matter expert(s), which may result in their response time exceeding this service standard.

You may also request a pre-submission meeting before filing an application with us. A pre-submission meeting may not be beneficial for all biocide applicants. In many cases, written guidance can be provided instead. As indicated in the application pathways and general requirements guidance, you are encouraged to contact NNHPD at nnhpd-dpsnso@hc-sc.gc.ca prior to submitting a formal pre-submission meeting request.

Meeting requests

You may request a pre-submission meeting at least one month prior to the proposed meeting date. Your pre-submission meeting request must be submitted as per the filing of information to Health Canada section.

Submit your meeting request in a separate document (not in the cover letter) and include the following information:

• the purpose of the meeting
• a brief description of the biocide to be discussed (e.g., active ingredient, physical form, method of application, and conditions of use)
• three proposed dates for the meeting
• preference for a meeting by teleconference or in person at the NNHPD workplace

If we determine a meeting is warranted, we will contact you to discuss the request. This discussion will include possible meeting dates, the overall content of the pre-submission package and confirmation of the number of meeting participants.

We may decline the meeting request if you don't include the information listed above.

If we consider that a formal meeting is not required, we will provide a response and rationale within a reasonable time period.

For more information on pre-submission meeting requirements, we invite you to consult the guidance on application pathways and general requirements.

Meeting packages

Once we have accepted the pre-submission meeting request and informed you of the date and time, you should submit the pre-submission meeting information package at least two weeks in advance of the meeting (refer to filing of information to Health Canada). If the information package includes a presentation, the slide deck should be submitted one week prior to the meeting. Pre-submission meeting packages should be as concise as possible and contain only the information listed below, where applicable:

• a cover letter
• the control number associated with the meeting
• a proposed meeting agenda
• a list of participants and their titles/roles
• a brief summary of the biocide, including the conditions of use for which approval will be sought, such as the physical form, intended use or purpose, and intended settings for use
• a list of the active ingredients and formulants of the biocide
• brief summaries of the safety, efficacy, and quality information (chemistry and manufacturing) relating to the biocide
• an overview of the market history of the biocide, including the foreign regulatory status of the biocide
• a list of specific issues or questions the applicant would like to discuss or have addressed
• the projected application filing date

Post-meeting requirements

It is the applicant's responsibility to take meeting minutes during a pre-submission meeting. These meeting minutes are to be provided to NNHPD within two weeks of the meeting for review and concurrence. We will provide you with our revisions, where applicable, within a reasonable time period. You should submit the final meeting minutes as per the filing of information to Health Canada section.

When filing a biocide application, you should indicate within the cover letter whether a pre-submission meeting was held, and the control number associated with that meeting.