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File a formal application for registration of pesticides

                                                      Date: 2006-05-08

The formal registration of pesticide application information

1 The applicant should be within the agency signed by the provincial pesticide certification views
(2) must provide two copies of the following materials and content should be exactly the same. One should be original, a copy can (but with six copies of application forms and product summary data). Copy of the data product chemistry, toxicology, efficacy, residue, environmental impact, packaging and labeling information should be, respectively, and the application form, the product summary data volumes bound. Application forms, product summary information and product safety data sheets should provide electronic text. Officially registered products for direct application, the applicant shall submit the interim stage of the registration stage and officially registered under the relevant information. Temporary registration period has been provided in the test and inspection data, the official registration of new pesticide application, can provide a copy; apply for other types of formal registration, make a written statement in the case, can no longer be available.
(1) "Application for official registration of pesticides."
(2) new pesticides should provide the following information:
① original drug:
A. Product summary data (origin, product chemistry, toxicology, environmental impact, such as registration information outside of a brief description)
B. Product chemistry data (the active ingredient, the original drug)
C. Toxicological information
D. Environmental impact information
E. The instructions are accompanied by labels or
F. Product Safety Data Sheet (MSDS)
G. Other information on it: in other countries or regions have the toxicology and environmental impact testing and registration information or a combination of query reports.
② Preparation:
A. Product summary data (origin, product chemistry, toxicology, efficacy, residue, environmental impact, such as registration information outside of a brief description)
B. Product chemistry data (except for temporary registration under the product chemistry data, should also provide storage stability at room temperature for more than 3 batches of reports)
C. Toxicological information
D. Efficacy data (two or more regions of different natural conditions, the model test report, the use of temporary registration of the product during the synthesis report)
E. Residual data (in our country for more than 2 years remaining of the test report)
F. Environmental impact information
G. The instructions are accompanied by labels or
H. Product Safety Data Sheet (MSDS)
I. Other information on it: in other countries or regions have the toxicology, efficacy, residue, environmental testing and registration information or a combination of query reports.
(3) Special new pesticide products should provide the following information:
① health use of pesticides (rodenticides, biochemical pesticides, botanical pesticides) TC:
A. Product Summary information (place of origin, product chemistry, toxicology, environmental impact, such as registration information outside of a brief description)
B. Product chemistry data (the active ingredient, the original drug)
C. Toxicological information
D. Environmental impact information
E. The instructions are accompanied by labels or
F. Product Safety Data Sheet (MSDS)
G. Other information: in other countries or regions have the toxicology and environmental impact testing and registration information or a combination of query reports.
② health with pesticide formulations:
A. Product summary data (origin, product chemistry, toxicology, efficacy, residue, environmental impact, such as registration information outside of a brief description)
B. Product chemistry data (except for temporary registration under the product chemistry data, should also provide storage stability at room temperature for more than 3 batches of reports)
C. Toxicological information
D. Efficacy data: two or more different natural conditions, including parts of demonstration test report (the external environment with preparations), the use of temporary registration of the product during the synthesis report.
E. Environmental impact information
F. The instructions are accompanied by labels or
G. Product Safety Data Sheet (MSDS)
H. Other information: in other countries or regions have the toxicology, efficacy, residue, environmental testing and registration information or a combination of query reports.
③ rodenticide formulations:
A. Product summary data (origin, product chemistry, toxicology, efficacy, residue, environmental impact, such as registration information outside of a brief description)
B. Product chemistry data (except for temporary registration under the product chemistry data, should also provide storage stability at room temperature for more than 3 batches of reports)
C. Toxicological information
D. Efficacy data: two or more different natural conditions, including parts of demonstration test report (on farmland, forests and grasslands on the use of rodenticides), the use of temporary registration of the product during the synthesis report.
E. Residual data (full applicator of the rodenticide)
F. Environmental impact information
G. The instructions are accompanied by labels or
H. Product Safety Data Sheet (MSDS)
I. Other information on it: in other countries or regions have the toxicology, efficacy, residue, environmental testing and registration information or a combination of query reports.
④ biochemical pesticide formulations:
A. Product summary data (origin, product chemistry, toxicology, efficacy, residue, environmental impact, such as registration information outside of a brief description)
B. Product chemistry data (except for temporary registration under the product chemistry data, should also provide storage stability at room temperature for more than 3 batches of reports)
C. Toxicological information
D. Efficacy data (two or more regions of different natural conditions, the model test report, the use of temporary registration of the product during the synthesis report)
E. Residual data (depending on the features and use of pesticides, provided in accordance with jury comments)
F. Environmental impact data (acute toxicity test provides silkworm report on the environmental risks of pesticides with special, should also provide additional information on the environmental impact.)
G. The instructions are accompanied by labels or
H. Product Safety Data Sheet (MSDS)
I. Other information: in other countries or regions have the toxicology, efficacy, residue, environmental testing and registration information or a combination of query reports.
⑤ microbial pesticide:
A. Product Summary data (origin, products of chemical and biological properties, toxicology, environmental impact, such as registration information outside of a brief description)
B. Chemical and biological characteristics of the product information (the active ingredient, the original drug)
C. Toxicological data (the active ingredient for confirmation or other mammals are not known pathogens that information; basic toxicological information; additional toxicological information)
D. Environmental impact information
E. The instructions are accompanied by labels or
F. Product Safety Data Sheet (MSDS)
G. Other information: in other countries or regions have the toxicology and environmental impact testing and registration information or a combination of inquiry report; variations in the environment and the risk of release descriptions.
⑥ microbial pesticide formulations:
A. Product summary data (origin, products of chemical and biological properties, toxicology, efficacy, residue, environmental impact, such as registration information outside of a brief description)
B. Chemical and biological characteristics of the product information (except when under the temporary registration of chemical information products, should also provide storage stability at room temperature for more than 3 batches of reports)
C. Toxicological data (the active ingredient for confirmation or other mammals are not known pathogens that information; basic toxicological data)
D. Efficacy data (two or more regions of different natural conditions, the model test report, the use of temporary registration of the product during the synthesis report)
E. Residual data (depending on the features and use of pesticides, provided in accordance with jury comments)
F. Environmental impact data (acute oral toxicity test of birds, fish acute toxicity test, acute oral toxicity test bees, bee acute contact toxicity test, acute toxicity test silkworm)
G. Accompanied by the label or instructions www.aqsiqccc.com
H. Product Safety Data Sheet (MSDS)
I. Other information: in other countries or regions have the toxicology, efficacy, residue, environmental testing and registration information or a combination of inquiry report; variations in the environment and the risk of release descriptions.
⑦ botanical pesticide formulations:
A. Product summary data (origin, product chemistry, toxicology, efficacy, residue, environmental impact, such as registration information outside of a brief description)
B. Product chemistry data (except for temporary registration under the product chemistry data, should also provide storage stability at room temperature for more than 3 batches of reports)
C. Toxicological information
D. Efficacy data (two or more regions of different natural conditions, the model test report, the use of temporary registration of the product during the synthesis report)
E. Residual data
F. Environmental impact information
G. The instructions are accompanied by labels or
H. Product Safety Data Sheet (MSDS)
I. Other information: in other countries or regions have the toxicology, efficacy, residue, environmental testing and registration information or a combination of query reports.
(4) new agents should also provide the following information:
① new dosage form:
A. Product summary data (origin, product chemistry, toxicology, efficacy, residue, environmental impact, such as registration information outside of a brief description)
B. Product chemistry data (except for temporary registration under the product chemistry data, should also provide storage stability at room temperature for more than 3 batches of reports)
C. Toxicological information
D. Efficacy data (the use of temporary registration during the product synthesis report)
E. Residual data
F. Environmental impact information
G. The instructions are accompanied by labels or
H. Product Safety Data Sheet (MSDS)
I. Other information: in other countries or regions have the toxicology, efficacy, residue, environmental testing and registration information or a combination of query reports.
② pesticide formulations minor optimization:
A. Product summary data (origin, product chemistry, toxicology, efficacy, residue, environmental impact, such as registration information outside of a brief description)
B. Product chemistry data (except for temporary registration under the product chemistry data, should also provide storage stability at room temperature for more than 3 batches of reports)
C. Toxicological information
D. Efficacy data (the use of temporary registration during the product synthesis report)
E. Residual data (such as one of the following conditions, our residue test results in the provision of summary information or written statement related to the case, you can remove the residue data requirements: a residual data of the applicants have been in our country have the same active ingredients, dosage forms , and methods of use of officially registered more than 6 years, and the application to optimize product formulations of active ingredients with small amount of active ingredient is the use of 1.5 times; b provide independent with the same active ingredients, formulations, and methods of use of the product information has been left authorized registrants, and the application to optimize product formulations of active ingredients with small amount of active ingredient is the use of 1.5 times.)
F. Environmental impact information
G. The instructions are accompanied by labels or
H. Product Safety Data Sheet (MSDS)
I. Other information: in other countries or regions have the toxicology, efficacy, residue, environmental testing and registration information or a combination of query reports.
③ new mixed formulations, drug fertilizer mixed formulations:
A. Product summary data (origin, product chemistry, toxicology, efficacy, residue, environmental impact, such as registration information outside of a brief description)
B. Product chemistry data (except for temporary registration under the product chemistry data, should also provide storage stability at room temperature for more than 3 batches of reports)
C. Toxicological information
D. Efficacy data (the use of temporary registration during the product synthesis report)
E. Residual data (or natural conditions in our country's provincial administrative regions of different farming systems more than 2 years of residual test report, such as products containing the active ingredients in the following conditions are met, one of our residue test results in the provision of information or related to a written summary Description of the case, you can remove the corresponding residue information requirements: a residual data of the applicants have been in our country have the same active ingredients, formulations, and methods of use of officially registered more than six years and apply for registration of products of mixed formulations The active ingredient is the use of active ingredients used 1.5 times the amount; b provide independent with the same active ingredients, formulations, and methods of use of the information registered by authorized, registered and apply for mixed formulations of the active ingredient in the product use Its active ingredient is 1.5 times the amount used.)
F. Environmental impact information
G. The instructions are accompanied by labels or
H. Product Safety Data Sheet (MSDS)
I. Other information on it: in other countries or regions have the toxicology, efficacy, residue, environmental testing and registration information or a combination of query reports.
④ new content:
A. Product summary data (origin, product chemistry, toxicology, efficacy, residue, environmental impact, such as registration information outside of a brief description)
B. Product chemistry data (except for temporary registration under the product chemistry data, should also provide storage stability at room temperature for more than 3 batches of reports)
C. Toxicological information
D. Efficacy data (the use of temporary registration during the product synthesis report)
E. Residual data (such as one of the following conditions, our residue test results in the provision of summary information or written statement related to the case, you can remove the corresponding residue information requirements: a residual data of the applicants have been in China to achieve the same effective ingredients, formulations, and methods of use of officially registered more than 6 years, and the application for registration of products use the active ingredient is the active ingredient use 1.5 times; b provide independent with the same active ingredients, formulations, and methods of use of information registered by the authority, and the application for registration of the active ingredients of the product is its use of 1.5 times the amount of active ingredient to use the following.)
F. Environmental impact information
G. The instructions are accompanied by labels or
H. Product Safety Data Sheet (MSDS)
I. Other information on it: in other countries or regions have the toxicology, efficacy, residue, environmental testing and registration information or a combination of query reports.

⑤ new penetrant (or synergist) mixed with pesticide formulations
A. The penetrant, synergist common name, chemical name, structure, basic physical and chemical properties, concentration and detection methods, sources, security and other domestic and foreign use
B. The penetrant, synergist indoor formulation screening report
C. Applicants relative to the company's products have been registered active ingredient types and formulations of the same content, but increased the penetrant or synergist product registration, the registration can provide information on new content, other cases should be mixed according to the new formulations or new Mixture registration information.
(4) the same pesticide product shall submit the following information:
① contain active ingredients made in China in the data protection registration and the registration of pesticides during the period, according to a new pesticide registration should be required to provide information.
② contain active ingredients made in China in the data protection registration and the registration period, no significant difference in the quality of the same original drug should provide the following information:
A. Product summary data (origin, product chemistry, toxicology, environmental impact and other information brief)
B. No significant difference in the quality of the original drug found to prove the same: the application products, including no significant difference in the quality of the original drug of the same product name, company name, registration number of pesticides and compared to determine the conclusion, the applicant for evidence related materials.
C. Product chemistry data
D. Toxicological information
E. Environmental impact information
F. The instructions are accompanied by labels or
G. Product Safety Data Sheet (MSDS)
H. Other information it
③ contain active ingredients made in China in the data protection registration and the registration period, no significant difference in the quality of the same preparation should provide the following information:
A. Product summary data (origin, product chemistry, toxicology, efficacy, residue, environmental impact, such as registration information outside of a brief description)
B. No significant difference in the quality of preparations determined to prove the same: the quality of products, including the application of the same preparation no significant difference in the product name, company name, registration number of pesticides and compared to determine the conclusion, the applicant for evidence related materials.
C. Product chemistry data
D. Toxicological information
E. Efficacy data
F. Residual data (such as identified by the same pesticide products registered in China has completed the application for registration of the product residue testing and the use of dose is 1.5 times the original dose, our residue test results in the provision of summary information or written statement related to the case , residues trial data can not provide, such as identified by the same registered pesticide products in China has completed the remaining tests, but the application for registration of products used dose is 1.5 times the original dose of more than provide one year in our country residues above the test report, such as identified by the same pesticide products registered in our residue test has not been completed, providing more than 2 years in our country's residual test report.)
G. Environmental impact information
H. The instructions are accompanied by labels or
I. Product Safety Data Sheet (MSDS)
J. Other information it
④ In addition to the first ①, ②, ③ the same items other than pesticide product, the original new drug by the corresponding specific pesticides or pesticide registration requirements of the new information; single-agent formulations according to the new content of the formal registration requirements and provide information; mixed formulations by New mixed formulations official registration requirements to provide information.
(5) expand the scope, use and change of use to change the dose of pesticide products should also submit the following information:
① expand the scope:
A. Product summary data (efficacy, residue, environmental impact, such as registration information outside of a brief description)
B. Efficacy data (the use of temporary registration during the product synthesis report)
C. Residual data (products applied for registration with the respective types of temporary registration of pesticide residues in the registration requests for information)
D. Environmental impact data (increased use of registration or registration to use the original pesticide product registration information provided does not meet environmental safety assessment requirements, should be added that the environmental impacts associated test data)
E. The instructions are accompanied by labels or
F. Other information
② change to use:
A. Product summary data (efficacy, residue, environmental impact, such as registration information outside of a brief description)
B. Efficacy data (the use of temporary registration during the product synthesis report)
C. Residual data (products applied for registration with the respective types of temporary registration of pesticide residues in the registration requests for information)
D. Environmental impact data (due to changes in use, resulting in the original pesticide product registration information provided does not meet requirements of environmental safety assessment, it should add the relevant environmental impact data)
E. The instructions are accompanied by labels or
F. Other information
③ change the dosage:
A. Product summary (including efficacy, residue and other information brief)
B. Efficacy data (more than 1 year of field plot efficacy trials report)
C. Residual data (dose is 1.5 times the original dose, it should provide more than 1 year in our country's residual test report)
D. The instructions are accompanied by labels or
E. Other

 


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