Pre-submission Consultation - Frequently Asked Questions
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- I have a pesticide that I wish to sell in Canada. What do I do?
- What is a pre-submission consultation?
- What is the goal of a pre-submission consultation?
- Is a pre-submission consultation required?
- How can I get the most out of my pre-submission consultation?
- Approximately how many days does it take until I can expect to receive my pre-submission consultation guidance?
- How do I apply for a pre-submission consultation?
- 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?
- My product is already registered in the United States. Does this information impact my application?
- 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?
- I am interested only in information regarding the value requirements for my product. Can I request a value-only pre-submission consultation?
- My product is currently under re-evaluation or special review, does this impact my application?
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 Canadas 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.
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.
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.
The pre-submission guidance provided by the PMRA will build upon information found in the PMRAs Online Decision Tree.
It is recommended that before you apply for a pre-submission consultation you review the Online Decision Tree and any applicable policy documents.
What is the goal of a pre-submission consultation?
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.
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.
Please note that a pre-submission consultation is not an application for registration. Its 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.
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.
Is a pre-submission consultation required?
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).
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)
- Applicants with specific scientific concerns regarding their product, including questions regarding science protocols
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.
How can I get the most out of my pre-submission consultation?
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.
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.
Approximately how many days does it take until I can expect to receive my pre-submission consultation guidance?
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, its important to provide all of the required pre-submission information when you submit your request.
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.
How do I apply for a pre-submission consultation?
By completing and providing the following:
- A Pre-submission Consultation Request Form;
- 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; and
- 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.
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.
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?
If you have a specific product and you want information on how to create a complete application to register or amend a pest control products registration, you may request a pre-submission consultation.
Some inquiries may be answered simply by either visiting the Online Decision Tree, or contacting the Pest Management Information Service who will direct your question to the appropriate official. Such inquiries include:
- 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 Act
Note: 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.
My product is already registered in the United States. Does this information impact my application?
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.
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, or please feel free to use our Online Decision Tree and look at our conventional data requirements.
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?
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).
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.
I am interested only in information regarding the value requirements for my product. Can I request a value-only pre-submission consultation?
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:
- 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);
- 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.
My product is currently under re-evaluation or special review, does this impact my application?
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.
More information on re-evaluation and special reviews are included in the following documents:
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