有关加拿大害虫防治产品提交前咨询的FAQs
临安科达认证技术咨询服务有限公司 时间：2022-03-11 点击：777 次
我有一种农药想在加拿大出售。我该怎么做？
1. I have a pesticide that I wish to sell in Canada. What do I do?
Before a pesticide can be advertised, sold or used in Canada, Health Canada’s Pest Management Regulatory Agency (PMRA) must ensure that there is no unacceptable risk to using that product in Canada. In most cases, a pre-market assessment of pest control products is required prior to any sale or use in Canada. The pre-market assessment process (or “registration”) requires that the submission of a complete application for registration includes the submission of all of the required forms, fees and scientific data to support the product. Additional information on the registration process can be found in the Registrants and Applicants section or by consulting our various policy and guideline documents.在加拿大广告，出售或使用农药之前，加拿大卫生部害虫管理监管局（PMRA）必须确保在加拿大使用该产品不会有不可接受的风险。在大多数情况下，在加拿大进行任何销售或使用之前，都需要对害虫防治产品进行售前评估。上市前评估流程（或“注册”）要求提交完整的注册申请包括提交所有必需的表格，费用和支持该产品的科学数据。有关注册过程的其他信息可以在``注册人和申请人''部分中找到，也可以参考我们的各种政策和指南文件。If the application for registration is approved, the product will receive a registration number, and will be eligible for advertising, use, distribution or sale in Canada.如果注册申请获得批准，则该产品将获得注册号，并且有资格在加拿大进行广告，使用，发行或销售。
2. What is a pre-submission consultation?
A pre-submission consultation is a no-cost service offered by the PMRA. The purpose of this service is to provide prospective applicants with written guidance to help them to generate and submit a complete, high quality application package to register a new pesticide or to amend the registration of an approved pest control product. After the written guidance has been provided and reviewed by the applicant, a meeting or teleconference can be scheduled should both the PMRA and the applicant determine it to be necessary.提交前咨询是PMRA提供的免费服务。该服务的目的是为准申请人提供书面指导，以帮助他们生成并提交完整的高质量申请包，以注册新农药或修改批准的害虫防治产品的注册。在申请人提供并审查了书面指导之后，如果PMRA和申请人都认为有必要，则可以安排召开会议或电话会议。It is recommended that before you apply for a pre-submission consultation you review applicable policy documents.
3. What is the goal of a pre-submission consultation?
提交前咨询的目的是什么？
While many questions can be answered by consulting our various policy documents, sometimes there are specific concerns regarding the requirements for registration.虽然可以通过查阅我们的各种政策文件来回答许多问题，但是有时对注册要求有特定的关注。In general, a pre-submission consultation will provide guidance on how to submit a complete, high quality application package to register or to amend a registered pest control product, including relevant website links and guidance on fees, application timelines, required forms and data requirements.通常，提交前的咨询将提供有关如何提交完整的高质量申请包以注册或修改已注册的虫害控制产品的指南，包括相关的网站链接以及有关费用，申请时间表，所需表格和数据要求的指南。The pre-submission guidance provided will be based upon the specific product information provided by the applicant. It should be noted that clearly communicated and detailed questions as well as an in-depth knowledge of your product, its uses, formulation and mode of action will help to enhance the guidance provided at the pre-submission consultation. Clearly indicated pest/host combinations proposed for the Canadian market, are vital to the Agency in determining the data requirements. Additional clarifications can be requested by the applicant once the pre-submission guidance is received and any applicable reference documents have been reviewed. All information submitted under a pre-submission consultation is strictly confidential.提供的提交前指南将基于申请人提供的特定产品信息。应该注意的是，清楚传达和详细的问题以及对您的产品，其用途，配方和作用方式的深入了解将有助于增强提交前咨询中提供的指导。为加拿大市场提议的明确指出的有害生物/寄主组合对原子能机构确定数据要求至关重要。一旦收到提交前的指导并且任何适用的参考文件都经过审查，申请人可以要求进行其他澄清。在提交前的咨询中提交的所有信息均严格保密。Please note that a pre-submission consultation is not an application for registration. It’s a mechanism for applicants to seek guidance on how to complete a high quality application package and to answer specific questions. The PMRA cannot make a decision on the acceptability of data or of scientific rationales (i.e., data waivers) under a pre-submission consultation.请注意，提交前的咨询不是注册申请。这是一种供申请人寻求有关如何完成高质量申请程序包并回答特定问题的指导的机制。PMRA无法在提交前的咨询中决定数据或科学依据（即数据豁免）的可接受性。In addition, the pre-submission consultation process is not a mechanism to seek approval of precedent based applications (e.g., Category C type applications), nor to seek information on the data protection status of products.此外，提交前的咨询过程不是寻求基于先例的申请（例如C类申请）或寻求产品数据保护状态信息的机制。
4. Is a pre-submission consultation required?
是否需要提交前咨询？
Pre-submission consultations are only required in the case of registering a microbial product, or if the applicant is requesting a joint review (i.e., a pre-submission request submitted concurrently to Canada and at least one other country).仅在注册微生物产品的情况下，或者如果申请人要求联合审核（即同时向加拿大和至少一个其他国家提交的提交前请求）时，才需要进行提交前咨询。A pre-submission consultation is also recommended for the following applicants, but is not mandatory:· Applicants who have never dealt with the PMRA· Applicants with non-conventional products (see Regulatory Directive (DIR2012-01), Guidelines for the Registration of Non Conventional Pest Control Products)· 拥有非常规产品的申请人（请参阅法规指令（DIR2012-01），非常规害虫防治产品注册指南）· Applicants with specific scientific concerns regarding their product, including questions regarding science protocols· 对其产品有特殊科学关注的申请人，包括有关科学规程的问题For Joint Review Applications, the pre-submission consultation package must be made concurrently to all participating countries. For further guidance on joint review pre-submission consultation requests please contact the Pre-submission Coordinator.对于联合审核申请，必须同时向所有参与国提交提交前咨询包。有关联合审核提交前咨询请求的更多指导，请联系提交前协调员。
5. How can I get the most out of my pre-submission consultation?
如何充分利用提交前的咨询？
A pre-submission consultation is an opportunity to obtain guidance on the registration process and application requirements. However, the specificity of the guidance is dependent upon the questions posed and areas of concern or interest that are identified by the applicant. As such, questions of a general nature will only receive general guidance. The pre-submission consultation guidance will be customized based upon the level of detail provided by the applicant on the proposed product.提交前的咨询是获得有关注册过程和申请要求的指导的机会。但是，指南的具体性取决于提出的问题以及申请人确定的关注或关注领域。因此，一般性问题仅会得到一般性指导。提交前的咨询指南将根据申请人对拟议产品的详细程度进行定制。As stated above, note that clearly communicated and detailed questions as well as an in-depth knowledge of your product, its uses, formulation and mode of action will help to enhance the guidance provided at the pre-submission consultation. Clearly indicated pest/host combinations appropriate in Canada, are vital to the Agency in determining the data requirements. Additional clarifications can be requested by the applicant once the pre-submission guidance is received and any applicable reference documents have been reviewed. All information submitted under a pre-submission consultation are strictly confidential.如上所述，请注意，传达清晰，详细的问题以及对产品，其用途，配方和作用方式的深入了解将有助于加强提交前咨询中提供的指导。明确指出适用于加拿大的有害生物/寄主组合对代理机构确定数据要求至关重要。一旦收到提交前的指导并且任何适用的参考文件都经过审查，申请人可以要求进行其他澄清。在提交前的咨询中提交的所有信息均严格保密。
6. Approximately how many days does it take until I can expect to receive my pre-submission consultation guidance?
大概需要多少天才能收到我的提交前咨询指南？
Pre-submission consultations have an administrative performance target such that 90% of all pre-submission consultation requests are to be processed within 80 days. The timeline starts when a complete pre-submission consultation package is received and concludes when the written guidance is provided to the applicant. This timeline may be extended if additional information is required from the applicant to support their pre-submission request. Therefore, it’s important to provide all of the required pre-submission information when you submit your request.提交前咨询的行政绩效目标是，所有提交前咨询请求中的90％将在80天内处理。时间线在收到完整的提交前咨询包时开始，并在向申请人提供书面指导时结束。如果要求申请人提供其他信息以支持其提交前请求，则可以延长此时间表。因此，在提交请求时必须提供所有必需的提交前信息。Please note that the timeline for a joint review pre-submission consultation will be determined by the regulating authorities involved in the pre-submission request.请注意，联合审核提交前咨询的时间表由提交前请求中涉及的监管机构决定。
7. How do I apply for a pre-submission consultation?
如何申请提交前咨询？
By completing and providing the following:1. A Pre-submission Consultation Request Form;2. A Statement of Product Specification Form (SPSF) (i.e., the recipe of your product formulation). The SPSF must list 100% of the ingredients in your product and their purpose. This information is strictly confidential; and2.《产品规格表声明》（SPSF）（即您产品配方的配方）。SPSF必须列出产品中100％的成分及其用途。此信息严格保密；和3. A draft product label appropriate for the Canadian market. The label must have complete use directions including specific pest/host combinations. For examples of how a label can be drafted, visit the PMRA Label Search Database, which contains approved labels for all currently registered pesticides.3. 适用于加拿大市场的产品标签草案。标签必须具有完整的使用说明，包括特定的有害生物/寄主组合。有关如何起草标签的示例，请访问PMRA标签搜索数据库，该数据库包含已批准的所有当前注册农药的标签。Applicants are encouraged to submit pre-submission requests using the e-Index Builder, to help minimise processing timelines. If, however, you are unfamiliar with submitting an electronic application, you can forward your electronic files in Microsoft Word or Adobe PDF format via email to the Pre-submission Coordinator.我们鼓励申请人使用e-Index Builder提交提交前的请求，以最大程度地缩短处理时间。但是，如果您不熟悉提交电子申请，则可以通过电子邮件将Microsoft Word或Adobe PDF格式的电子文件转发给预提交协调员。
8. I have a specific set of questions about a product I wish to register. Do I need to make a pre-submission consultation request to have these answered?
关于我要注册的产品，我有一组特定的问题。我需要提出提交前的咨询请求才能回答这些问题吗？
If you have a specific product and you want information on how to create a complete application to register or amend a pest control product’s registration, you may request a pre-submission consultation.如果您有特定产品，并且想要有关如何创建完整的申请来注册或修改害虫控制产品注册的信息，则可以请求提交前咨询。Some inquiries may be answered simply by contacting the Pest Management Information Service who will direct your question to the appropriate official. Such inquiries include:只需联系``害虫管理信息服务''即可回答一些查询，后者将把您的问题转给相应的官员。此类查询包括：· Basic inquiries on simple topics such as the registration review timelines· Where to locate application forms· Questions concerning emergency registrations or research authorizations· Questions concerning notification or non-notification· If a product is subject to the Pest Control Products ActNote: The PMRA is unable to answer questions regarding the potential data protection implications for a proposed product or the acceptability of an application to qualify as a Category C type application.注意：PMRA无法回答有关拟议产品的潜在数据保护含义或应用程序是否可被视为C类申请程序的可接受性的问题。
9. My product is already registered in the United States. Does this information impact my application?
我的产品已经在美国注册。这些信息会影响我的申请吗？
No. The Canadian Pest Control Products Act and Regulations are different than the regulations found in the United States. As such, the PMRA would need to conduct an independent evaluation of your product for its registration prior to any marketing, sale or use in Canada. It is however helpful for us to know the registration status of your product. These details can be part of your pre-submission consultation package.不会。加拿大《虫害防治产品法》和法规与美国的法规不同。因此，在加拿大进行任何营销，销售或使用之前，PMRA需要对您的产品进行独立评估以进行注册。但是，这对我们了解您产品的注册状态很有帮助。这些详细信息可以作为提交前咨询包的一部分。While the PMRA will need to assess your product, data requirements can be similar between the United States Environmental Protection Agency and the PMRA. This can be discussed in further detail during a pre-submission consultation. Please take a look at our conventional data requirements.虽然PMRA需要评估您的产品，但EPA和PMRA之间的数据要求可能相似。可以在提交前的咨询中进一步详细讨论。请查看我们的常规数据要求。
10. My product is a pesticide in Canada, but it is on the 25b list with the United States Environmental Protection Agency. Do I require registration in Canada?
我的产品在加拿大是杀虫剂，但在美国环境保护署（EPA）中列于25b。我需要在加拿大注册吗？
Your product would be regulated as a pesticide in Canada. The PMRA does not have a similar list of exempted products based upon the active ingredient(s).您的产品将在加拿大被管制为杀虫剂。PMRA没有基于活性成分的类似豁免产品清单。The PMRA does, however, tier the data requirements for certain types of non-conventional products. Typically, these products require Tier I data to show that there is no unacceptable risk to using the product and that the product has value.但是，PMRA确实对某些类型的非常规产品的数据要求进行了分层。通常，这些产品需要使用Tier I数据来表明使用该产品没有不可接受的风险并且该产品具有价值。
11. I am interested only in information regarding the value requirements for my product. Can I request a value-only pre-submission consultation?
我只对有关产品价值要求的信息感兴趣。我可以要求仅提交价值的咨询吗？
Yes. A value-only pre-submission consultation is possible. If you have specific questions regarding the value requirements for product registration, it is very important to provide the following information:是。可能仅提供值前的咨询。如果您对产品注册的价值要求有特定疑问，提供以下信息非常重要：· the product directions for use (application rate or rate range, timing of initial application and re-application, and maximum number of seasonal applications, if applicable);· 产品使用说明（施用率或施用率范围，初次施用和再施用的时间以及季节性施用的最大数量（如果适用））；· what crops or use sites the product is to be applied on;· what pests it will be used to manage; and· what the expected level of control will be for each of the pests.Additional value-related information can be found in Regulatory Directive (DIR2013-03), Value Assessment of Pest Control Products and in other Guidance Documents found on our website.有关其他与价值有关的信息，请参见我们网站上的《法规指令（DIR2013-03），病虫害防治产品的价值评估》以及其他指导文件。
12. My product is currently under re-evaluation or special review, does this impact my application?
我的产品目前正在重新评估或特殊审查中，这会影响我的申请程序吗？
Yes, the outcome of a re-evaluation or special review may impact your application. For example, as a result of re-evaluation or special review, the uses accepted for continued registration as well as the conditions of use may change.是的，重新评估或特殊审核的结果可能会影响您的申请。例如，由于重新评估或特别审查的结果，继续注册所接受的用途以及使用条件可能会发生变化。Following a re-evaluation or special review, the PMRA publishes the proposed decisions for consultation before making a final decision.
经过重新评估或特别审查后，PMRA会在做出最终决定之前发布建议的决定供咨询。
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