Pre-submission Consultations

What is a pre-submission consultation?

A pre-submission consultation is a service offered at no cost by Health Canada's Pest Management Regulatory Agency that provides regulatory guidance to registrants or applicants prior to the submission of an application to register or amend a pest control product. The pre-submission process may also be utilized as a mechanism for obtaining guidance on a study protocol. For additional information on pre-submission consultations, please visit our Frequently Asked Questions.

When should a pre-submission consultation be requested?

Pre-submission consultations are recommended for:

• new registrants with limited experience with the Canadian pesticide regulatory system
• products that may qualify as Low-Risk Biochemical / Non-Conventional Pesticides (e.g., essential oils, food grade actives)
• products that contain active ingredients under re-evaluation

Pre-submission consultations are required for:

• Joint Review requests
• Microbial applications

For an overview of the Joint Review pre-submission consultation process please refer to the procedures section on the DRAFT Guidance Document on the Planning and Implementation of Joint Reviews of Pesticides.

Components of a complete pre-submission consultation package are:

1. Pre-submission Consultation Request Form (form #6117)
   
   The PMRA Pre-submission Consultation Request captures the purpose of the pre-submission request and provides an opportunity to identify specific questions or issues. The agency can only provide meaningful guidance if the information received is detailed.
2. Proposed Product Label

   Required to identify the proposed uses (e.g., application rates, method of application). The uses should be very specific (e.g., for use on corn to control sow-thistle). Do not use generic terms such as controls insects.

   A United States Environmental Protection Agency (U.S. EPA) registered product label will suffice if the use pattern is the same as proposed for use in Canada.
3. Statement of Product Specification Form (form 6003)

   The Statement of Product Specification Form is required to verify product formulation (active ingredient and formulants).

   A U.S. EPA specification form will suffice if the formulation is identical to the proposed Canadian formulation.
4. Additional information as required for Microbial and Low-Risk/Non-Conventional products:

   Microbials: refer to section 3.0 of Regulatory Directive (DIR2001-02), Guidelines for the Registration of Microbial Pest Control Products

   Low-Risk/Non-Conventional: refer to section 3.1 of Regulatory Directive (DIR2012-01), Guidelines for the Registration of Non Conventional Pest Control Product.

Note: The components outlined above are not required for a protocol review. The only documentation requirement is the actual study protocol.

Pre-submission Process Overview/Outcome:

A complete pre-submission consultation package can be sent via mail, email or via the Electronic Pesticide Regulatory System (e-PRS). Once a pre-submission number is assigned an acknowledgment of receipt will be sent to the applicant.

The pre-submission coordinator will then verify that all components have been submitted and request additional information or clarifications from the applicant as required. The pre-submission coordinator will also consult the science divisions as appropriate.

The pre-submission coordinator will then prepare and send a written response to the applicant, in the form of a pre-submission guidance template, which will address all of the questions/issues outlined on the pre-submission request form. The guidance will also outline the submission category, fees, timeline and data requirements.

If the applicant has additional clarifications after reviewing the pre-submission guidance they may contact the pre-submission coordinator. A meeting or teleconference may be scheduled depending upon the nature of the clarification request. An agenda outlining the specific clarifications will be required before a meeting or teleconference is scheduled.

Note: The pre-submission process for Joint Reviews, Microbials and Low-Risk/Non-Conventional products will follow the procedures outlined in their respective Regulatory Documents.

Caveats:

Guidance provided under a pre-submission consultation is valid for a 24 month period.

New Regulatory Directives or Proposals may impact the pre-submission guidance previously provided by the Agency.

Applicants seeking approval of data waivers must be aware that the guidance provided is based upon the limited information outlined in the waiver and can only be fully assessed under the context of the complete submission package.

For further information, please contact the Screening and Pre-submission Consultation Section.