提交前的咨询是加拿大卫生部害虫管理管理机构免费提供的一项服务，在提交注册或修改害虫控制产品的申请之前，向注册人或申请人提供监管指导。提交前过程也可以用作获取研究方案指南的机制。
What is a pre-submission consultation?
什么是提交前咨询？
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.提交前的咨询是加拿大卫生部害虫管理管理机构免费提供的一项服务，在提交注册或修改害虫控制产品的申请之前，向注册人或申请人提供监管指导。提交前过程也可以用作获取研究方案指南的机制。
When should a pre-submission consultation be requested?
什么时候应该要求提交前咨询？
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)· 可能属于低风险生化/非常规农药的产品（例如精油，食品级活性物质）· products that contain active ingredients under re-evaluationPre-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an overview of the Joint Review pre-submission consultation process please refer to the procedures section on the DRAFT Guidance Document on the Planning and Implementation of Joint Reviews of Pesticides.有关联合审查提交前咨询过程的概述，请参阅《关于农药联合审查的计划和实施的DRAFT指导文件》中的程序部分。
Components of a complete pre-submission consultation package are:
完整的提交前咨询包的组成部分包括：
1. Pre-submission Consultation Request Form (form #6117)
提交前咨询请求表（表格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.PMRA提交前咨询请求''说明了提交前请求的目的，并提供了识别特定问题的机会。仅当收到的信息详细时，代理商才能提供有意义的指导。
2. Proposed Product Label
拟议产品标签
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.识别拟议用途所必需的（例如，施用量，施用方法）。用途应非常明确（例如，用于玉米以控制母蓟）。请勿使用通用术语，例如控制昆虫。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.如果使用方式与加拿大建议的使用方式相同，则美国环境保护署（U.S.EPA）注册的产品标签就足够了。3. Statement of Product Specification Form (form 6003)
The Statement of Product Specification Form is required to verify product formulation (active ingredient and formulants).需要《产品规格表声明》来验证产品配方（有效成分和配方）。A U.S. EPA specification form will suffice if the formulation is identical to the proposed Canadian formulation.如果配方与建议的加拿大配方相同，则以美国EPA规格表为准。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微生物：参见法规第3.0节（DIR2001-02），《微生物有害生物防治产品注册指南》Low-Risk/Non-Conventional: refer to section 3.1 of Regulatory Directive (DIR2012-01), Guidelines for the Registration of Non Conventional Pest Control Product.低风险/非常规风险：请参阅法规指令（DIR2012-01）第3.1节，非常规害虫防治产品注册指南。Note: The components outlined above are not required for a protocol review. The only documentation requirement is the actual study protocol.注意：协议概述不需要上述组件。唯一的文件要求是实际的研究方案。
Pre-submission Process Overview/Outcome:
提交前流程概述/结果：
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.可以通过邮件，电子邮件或电子农药监管系统（e-PRS）发送完整的提交前咨询包。一旦指定了提交前的编号，就会将收据的确认发送给申请人。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.提交前的协调员将验证所有组件均已提交，并根据需要向申请人要求提供其他信息或澄清。提交前的协调员还将酌情咨询科学部门。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.然后，提交前协调员将以提交前指导模板的形式准备并发送书面回复给申请人，该模板将解决提交前请求表中概述的所有问题/问题。该指南还将概述提交类别，费用，时间表和数据要求。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.如果申请人在审查了提交前的指南后还有其他说明，可以联系提交前的协调员。可以根据澄清请求的性质安排会议或电话会议。在安排会议或电话会议之前，将需要一个概述具体说明的议程。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.注意：联合审核，微生物和低风险/非常规产品的提交前流程将遵循其各自法规文件中概述的程序。
Caveats:
注意事项：
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.新的法规指令或提案可能会影响到代理机构先前提供的提交前指南。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.
寻求批准数据豁免的申请人必须意识到，所提供的指导是基于豁免中概述的有限信息，并且只能在完整的提交材料包的背景下进行全面评估。
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