A pre-submission consultation is a service offered at no cost by the Agency that provides regulatory advice 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 advice on a study protocol.
Pre-submission consultations are recommended for:
Pre-submission consultations are required for:
For an overview of the Joint Review pre-submission consultation process please refer to the procedures section on the DRAFT Guidance Document on the Planning and Implementation of Joint Reviews of Pesticides.
Note: The components outlined above are not required for a protocol review. The only documentation requirement is the actual study protocol.
A complete pre-submission consultation package can be sent via mail or email. 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 advice template, which will address all of the questions/issues outlined on the pre-submission request form. The advice will also outline the submission category, fees, timeline and data requirements.
If the applicant has additional clarifications after reviewing the pre-submission advice 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.
Advice provided under a pre-submission consultation is valid for a 24 month period. It is recommended that a second request be submitted if an applicant wishes to submit an application for registration after the 24 month validity period.
New Regulatory Directives or Proposals may impact the pre-submission advice previously provided by the Agency.
Applicants seeking approval of data waivers must be aware that the advice 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.