PMRA Guidance Document, Organizing and Formatting a Complete Submission for Pest Control Products

• Health Canada – Pest Management Regulatory Agency
• 10 November 2022

Summary

This guidance document assists applicants in the preparation of a complete, properly formatted and organized application to register a new pest control product or amend an existing registration with Health Canada's Pest Management Regulatory Agency (PMRA). Complete and well-organized submissions are more likely to pass the PMRA's verification, screening and scientific review processes and will contribute to the increased efficiency of the regulatory process.

This document replaces the 2003 edition of Organizing and Formatting a Complete Submission for Pest Control Products (updated 2009), as well as the regulatory note Guidance on Selecting the Correct Category for Pest Control Product Submissions.

The guidance document includes clarifications, updates and additional information related to submission requirements and processing. Further amendments have been made as a result of the updating of the following guidance documents:

• Management of Submissions Policy
• Guidelines for the Registration of Non-Conventional Pest Control Products
• Notification/Non-notification
• Pest Control Products Fees and Charges Regulations
• Memorandum to Applicants and Registrants: Data Protection Submission Review Process

Introduction

In Canada, pest control products are carefully evaluated according to rigorous scientific standards by the PMRA, the branch of Health Canada that administers the Pest Control Products Act on behalf of the Minister of Health. The Organisation for Economic Co-operation and Development (OECD) has established protocols and internationally accepted test guidelines and principles of Good Laboratory Practices that are required by Health Canada to conduct the evaluations.

Companies that want to market a pest control product in Canada must submit a detailed information package to Health Canada for review. Health Canada uses this information to determine if the product meets current standards for protection of human health and the environment and if the product has value. The service standard for Health Canada's evaluations varies depending on the complexity of each submission. The PMRA conducts its own independent review of new active ingredients presented for registration.

Across this spectrum of needs, the PMRA strives to continuously improve its ability to manage and process submissions and ensure that the Canadian pesticide industry continues to adhere to international standards and practices.

This document will focus on:

• The registration process and how to organize a complete submission package;
• Procedural, organizational and formatting improvements;
• Electronic tools available to assist applicants in preparing for submission; and
• An overview of the Pest Control Products Fees and Charges Regulations.

For more information please contact the Pest Management Information Service.