Pre-submission Consultations

Help on accessing alternative formats, such as Portable Document Format (PDF), Microsoft Word and PowerPoint (PPT) files, can be obtained in the alternate format help section.

Richard Kenny
A/Section Head
Screening and Pre-submission Consultation Section
Submission and Information Management Division, Registration Directorate

Overview

• Pre-submission Consultation
• When to request a Pre-submission Consultation?
• Complete Pre-submission Consultation Package
• Process and Contacts

Pre-submission Consultation

• An opportunity for a registrant or applicant to request information on the application requirements and process prior to data generation and submission.
• Facilitate progress through the screening and review process.
• A means to obtain advice on a study protocol.
• The objective is to aid the registrant/applicant in preparing a complete, high quality submission package.

When to request a Pre-submission Consultation?

• New Registrants
• Joint Review
  • A pre-submission consultation is mandatory for a Joint Review
• Biopesticides
  • Mandatory for Microbials as per Section 3.0 of DIR2001-02, Guidelines for the Registration of Microbial Pest Control Agents and Products
• Novel Product Types
  • e.g. essential oils, some swimming pool products
• Actives with issues (e.g. Re-evaluation)

Complete Pre-submission Consultations package

• Completed Pre-submission Consultation Form
  • Outlines the purpose of the applicant request and identifies target questions.
  • Will be available on the PMRA website in the future. Currently available upon request.
• Proposed label
  • Required to identify proposed uses, rates, method of application, etc.
• Product Specification Form (Form 6003)
  • Indicates active ingredients.
  • Required to verify formulation and identify any formulant issues.

Process Steps

• Applicant submits a request for a pre-submission consultation with all information.
  • Mail
  • E-mail - pmra-arla_presubs@hc-sc.gc.ca
• The PMRA assigns a pre-submission number for tracking purposes and acknowledges receipt of request.
• Pre-submission Consultation Coordinator verifies all components are present.
• If clarifications are required the applicant is contacted.
• Coordinator screens the request. Consults with Science Review Divisions for advice if necessary.
• A PMRA written advice response is prepared and forwarded to the applicant. The advice is intended to provide a focus for discussion at a subsequent meeting or conference call, if one is necessary.
• The PMRA advice includes the submission category, timelines, fees, DACO tables and science advice.
• Examples of Science advice may include:
  • Identifying additional data requirements
    • Data requirements that are conditionally required may become required.
  • Providing guidance on the number of efficacy trials
• Caveats
  • Advice provided under a pre-submission consultation is valid for a 24-month period. It is recommended that a second request be made if a submission is not provided within the 24-month period.
  • Data Waivers: advice provided is based on the limited information provided. The waiver can only be fully assessed in the context of the subsequent data submission.

Common Issues

• Missing documentation (e.g. application form, label or PSF)
• Incomplete information on forms
  • Active ingredient/formulants missing from PSF
  • Label uses or rates are vague or not specified
• Applicant not providing clear and concise questions
  • Purpose of the pre-submission
  • What type of advice is being requested
    e.g. specific questions for an area of PMRA expertise
• Time delays in clarification responses

Pre-submission Consultation Contacts

Telephone
1-800-267-6315 (in Canada)
613-736-3799 (outside Canada)
613-736 3798 (fax)

E-mail
pmra-arla_pre-subs@hc-sc.gc.ca
pmra_infoserv@hc-sc.gc.ca

Mail
Stéphane Lavigne or Richard Kenny
Screening and Pre-submission Consultation Section
Submission Coordination Division
Pest Management Regulatory Agency
2720 Riverside Drive
Ottawa, Ontario K1A 0K9