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Privacy notice statement

Health Canada

Collection and use of personal information in this application is in accordance with the federal Privacy Act.

The personal information you provide is collected under the authority of section 6(1)(a) of the Pest Control Product Regulations for the purpose of contacting the applicant in regard to the application and to communicate any decisions and outcomes of the application.

Why are we collecting your personal information?: We require your personal information for the purpose of contacting the applicant in regards to the application and to communicate any decisions or outcomes of the application.
Will we use or share your personal information for any other reason?: Company names are disclosed after the Pest Management Regulatory Agency (PMRA) makes a decision or outcome on an application.
What are your rights?: The Privacy Act gives you the rights of access to, correction of and protection of your personal information. You have a right complain to the Privacy Commissioner of Canada if you feel your personal information has been handled improperly. For more information about these rights, or about how we handle your personal information, please contact the PMRA Information Service.

Security notice: up to Protected B only

This site is not approved by Health Canada/Public Health Agency of Canada for storage above Protected B information. Only up to Protected B information may be stored on this site.

Instructions

About this online form

Applicants should consult the appropriate guidance documents in preparing for their pre-submission consultation. Regulatory documents are located on the Health Canada - Pesticides and Pest Management Reports and Publications website under Policies and Guidelines. Forms and their associated documents are located on the Health Canada - Pesticides and Pest Management website under For registrants and applicants - General information - Forms.

For information on the required elements of a proposed text label refer to sections 22–32 (inclusive) of the Pest Control Products Regulations.

The PMRA may determine, based on the information provided, that certain requested expertise may not be required.

Please note that a written response in the form of guidance will be provided. Meetings with pre-submission consultation applicants will not be considered until the written guidance has been provided by the PMRA. If upon review of the guidance, further technical questions arise, a meeting can be considered. Please submit your Pre-submission Consultation Request form to the pmra.presubs-prealables.arla@hc-sc.gc.ca.

How to work with this online form

When working with this online form, you can save it to your computer at any time by clicking the 'Save Draft' button at the bottom of the form. This will generate a draft XML file.

You can continue to work on the form in subsequent sessions by loading a draft XML file in the "Load a draft XML file" section, at the top of the form.

Once you have completed the form, click the 'Save Final' button at the bottom of the form to generate a Microsoft Word file.

Instructions for completing sections of this online form

Instruction 1

Microbial products: The applicant is requested to comply with Section 4.0 of the Guidance for the registration of microbial pest control agents and products [2021], and submit a pre-submission consultation package containing the required Part 1 and Part 2 information elements and other data (e.g. human health and environmental safety) as per Data Code (DACO) table in Appendix II, if available.

For biopesticides other than microbials: The applicant is required to submit a pre-submission consultation package of information containing the following, as appropriate: draft label, product specification and Chemical Abstracts Service (CAS) numbers for all active ingredients, formulants and impurities; product profile, proposed use pattern and international regulatory status; short summaries of available information regarding efficacy, manufacturing processes, product specifications, safety to the environment and human health; scientific rationales to support proposed data waivers that the proponent would like to include in the formal submission, and index of data and waivers submitted to the Unites States Environmental Protection Agency (USEPA) or other Organization of Economic Cooperation and Development (OECD) country, if relevant; whether the active ingredient meets the CODEX criteria for a food grade chemical. This will allow the PMRA to determine whether a reduced data set is possible.

Refer to Section 5.3 of the Regulatory Directive DIR2002-02, The PMRA Initiative for Reduced-Risk Pesticides for guidelines on preparing a reduced-risk rationale. The rationale should be submitted with the pre-submission consultation request.

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Instruction 2

Refer to Section 2.0 of the PMRA Guidance Document, Registration of Non-Conventional Pest Control Products [2023], for guidelines on preparing a rational requesting non-conventional status. The rationale should be submitted with the pre-submission consultation request.

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Instruction 3

Nanomaterials (e.g. silver) must be identified during the pre-submission consultation. Information on Health Canada's working definition for nanomaterials can be found under Section 4.1 of the Policy Statement on Health Canada's Working Definition for Nanomaterial.

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Instruction 4

To be eligible for a joint review, concurrent applications must be made to all participating regulatory authorities. For new active ingredients, the source of the Technical Grade Active Ingredient (TGAI) must be the same in each jurisdiction and at least one end-use product must have the same formulation. If the TGAI is already registered in all participating countries, a second-entry joint review application can be made if the formulation is the same and proposed new uses are the same.

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Form 6117 - Presubmission consultation request