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What matters should be paid attention to when applying for pesticide registration application method change?
- Categories:Industry News
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- Time of issue:2021-02-25 14:20
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(Summary description)In the process of pesticide registration, there are 7 types of registration changes, including expanding the scope of use, changing the method of use, increasing the dosage, reducing the dosage, the quality specification or composition of the original drug (parent drug), and the formulation quality specification or composition change.
What matters should be paid attention to when applying for pesticide registration application method change?
(Summary description)In the process of pesticide registration, there are 7 types of registration changes, including expanding the scope of use, changing the method of use, increasing the dosage, reducing the dosage, the quality specification or composition of the original drug (parent drug), and the formulation quality specification or composition change.
- Categories:Industry News
- Author:
- Origin:
- Time of issue:2021-02-25 14:20
- Views:
1. Information to be submitted for changes in usage
1.1 General information
① Application form; ② Declaration of the applicant; ③ Copy of the registration certificate; ④ Explanation and reason for the change; ⑤ Label and manual; ⑥ Other materials related to the registration change.
2. Toxicology
① High-level test data required for health risk assessment (if the primary health risk assessment shows that pesticides pose an unacceptable health risk to humans, the corresponding high-level test data can be provided, including but not limited to field exposure test of pesticide applicator, residents Exposure simulation test); ②Health risk assessment report (submit the applicator's health risk assessment report or residents' health risk assessment report).
3. Efficacy
3.1 Field trials
Note: Biochemical pesticides, microbial pesticides and plant-derived pesticide preparations involve new use methods for products, please refer to the registration requirements of pesticide preparations for biochemical pesticides, microbial pesticides and plant-derived pesticide preparations for category I (new use methods) respectively; Products that do not involve new methods of use can be provided for 1 year and 3 places (forestry drugs, crops grown in local areas, or diseases, pests, and weeds in local areas), 1 year and 4 places (insecticides, fungicides) or 1 year 5 (herbicide, plant growth regulator) field efficacy test report; sanitary pesticide preparations shall refer to category I (new use method) in the registration data requirements of sanitary pesticide preparations; rodenticide preparations shall refer to rodenticide pesticides Type I (new use method) in the preparation registration data request provides data.
3.2 Other information
If necessary, provide instructions on the selection of field trials; the impact on the main predatory and parasitic natural enemies in the field; the impact on the neighboring crops; the registered use of the crop or the control object abroad; the product features and precautions for use; others related to this Information about pesticide varieties and scope of use, etc.
3.3 Comprehensive evaluation report (summary summary of drug efficacy data).
4. Residue
① Pesticide residue test data in crops; ② Residue analysis method data; ③ Dietary risk assessment report. Note: Non-edible crops and non-feed crops, sanitary insecticides and rodenticides do not need to be provided.
5. Environmental impact
① Supplement environmental impact data; ②Environmental risk assessment report.
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