On the implementation of the "pesticide registration requirement" to inform on specific issues
Provinces, autonomous regions and municipalities pesticide certification (management) of the (Board, Station), pesticide manufacturers and related test unit:
To better implement the "pesticide registration requirement" a really good job and the processing of applications for registration of pesticides are on the "pesticide registration requirement" on specific issues as follows supplement:
First, the recognition of test reports
In addition to "pesticide registration requirement" demands to be carried out in our pilot project, other projects can use according to China's bilateral or multilateral agreements to determine the jury consider the registration or recognition of test reports issued by foreign institutions. The test report shall be in Chinese or English, the content should be in line with China's relevant provisions of the pesticide registration trial, the report should be attached to Chinese English summary data. GLP test report issued by the agency received GLP certification should also be attached to the relevant evidence.
The trial of a special pesticide, such as the Ministry of Agriculture is currently no approved test unit to check or test unit bearing temporarily do not have the test conditions, manufacturers may agree with the Ministry of Agriculture commissioned a testing capacity of the unit.
Second, the test report of authorized
Information and independently owned businesses to obtain the registration of pesticides, may authorize other companies to use the relevant test data.
(A) Product Toxicology (acute toxicity test data excluded) and the environmental impact of test data can be delegated to the same quality and no significant difference in pesticide products.
(B) single-agent residue trial data can be granted to active ingredients, dosage form, scope and methods using the same active ingredients dose of 1.5 times the single-agent and mixed formulations use; mixed formulations residual data can be licensed to formula , dosage form, scope and methods of using the same active ingredients dose of 1.5 times the use of mixed formulations.
Officially registered more than 6 years remaining product data reduction principles above.
Third, warehousing, preservation, and preservation of pesticide residue testing and health with indoor pesticide formulation screening report mixed formulations
Relatively stable environmental conditions in places (not including protected), such as warehousing, preservation, preservation of the use of pesticides, residues may be a one-year test report. Constant temperature and humidity conditions and products while non-constant temperature and humidity conditions used, it should be, respectively, under the conditions in the corresponding residue test. Residue trials required the same number of "pesticide registration requirement" in Annex 2.
Mixed with pesticide formulations applied health field trials and temporary registration is required to provide "mixed purpose of description and formulation development, indoor screening report or reports."
Fourth, on the official registration renewal
Official registration renewal unless otherwise specified product test data required to provide the products, other products can provide a comprehensive report. Comprehensive report should include toxicology, environmental, residual and other summary data or data and the actual use of the registration period, the effect, resistance, injury, impact on natural enemies, accidents and so on.
Fifth, on the original source of drug registration and proof of original drug
The following circumstances require reduction of the original drug (parent drug) to register or proof of original drug sources, companies can apply for temporary registration by the pesticide Pesticide Registration Evaluation Committee or the Review Committee approval of, you can make the appropriate reduction, but the preparations for the original application Registration required drug test related projects.
(A) microbial pesticides;
(B) plant-pesticides;
(C) biochemical pesticides;
(D) of genetically modified organisms;
(E) biological natural enemies;
(Vi) other industries widely used active ingredients or chemicals;
(Vii) other pesticides is difficult to produce the original drug.
Six other supplementary provisions
Not been returned by the assessment of applications for registration of products, gone through the notice of the applicant within one year with re-apply for registration, you can use the original information provided.
Two ОО April 7, 2009