PMRA Presubmission Consultation Request
Privacy Notice Statement
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 regards to the application and to communicate any decisions and outcomes of the application.
The Privacy Act gives you the rights of access to, correction of and protection of your personal information. For further information about this Privacy statement please contact Health Canada's Access to Information and Privacy Coordinator by email at firstname.lastname@example.org.
- (a) For information on the required elements of a proposed text label refer to sections 22–32 (inclusive) of the Pest Control Products Regulations.
- (b) The PMRA may determine, based on the information provided, that certain requested expertise may not be required.
- (c) Microbial products: The applicant is requested to comply with Section 3.0 of Regulatory Directive DIR2001-02, Guidelines for the Registration of Microbial Pest Control Agents and Products, and submit a presubmission consultation package containing the required Part 1 and Part 2 information elements and other data (e.g. human health and environmental safety), if available, including a proposed DACO table. The PMRA must receive the presubmission package at least 45 days prior to a proposed meeting date.
- (d) For biopesticides other than microbials: The applicant is required to submit a presubmission consultation package of information at least 45 days prior to a proposed meeting date 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 USEPA or other 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.
- (e) Refer to Section 5.3 of Regulatory Directive DIR2002-02, The PMRA Initiative for Reduced-Risk Pesticides, for guidelines on writing a reduced-risk rationale.
- (f) Refer to Section 2.0 of Regulatory Directive DIR2012-01, Guidelines for the Registration of Non-Conventional Pest Control Products, for guidance on preparing a rational requesting non-conventional status. The rationale should be submitted with the pre-submission consultation request.
- (g) Nanomaterials (e.g. silver) must be identified during the pre-submission consultation. Information on Health Canada's working definition for nanomaterials can be found at http://www.hc-sc.gc.ca/sr-sr/consult/_2010/nanomater/draft-ebauche-eng.php
- (h) 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 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.
Applicants should consult the appropriate guidance documents in preparing for their presubmission consultation. Regulatory directive documents are located on the Health Canada website in the Pesticides and Pest Management Reports and Publications section under Policies and Guidelines. Documents are also located along with the form, on the Health Canada website in the Pesticides and Pest Management section under Registrants and Applicants - Forms.
- Statement of Product Specification Form Guidance Document
- Regulatory Directive DIR98-04, Chemistry Requirements for the Registration of a Technical Grade of Active Ingredient or an Integrated System Product
- Regulatory Directive DIR98-03, Chemistry Requirements for the Registration of a Manufacturing Concentrate or an End-Use Product Formulated from Registered Technical Grade of Active Ingredients or Integrated System Products
- Regulatory Directive DIR2006-02, Formulants Policy and Implementation Guidance Document
Please note that a written response will be provided unless the review team determines that a teleconference or meeting is required.
If your company already has a product registered with the PMRA, please submit your pre-submission application with an electronic index using the PMRA's eIndex Builder. The Builder, guidance documents, and where to submit the completed package can be found in the ePRS section of the PMRA's web site.
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