巴拉圭登记要求.doc

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1、DocumentsneededforregistrationofpesticideinParaguay巴拉圭登记要求原药的登记要求序号英文原文中文翻译1LetterofAuthorization.（Noneedtobelegalized）授权信（无需使馆认证）2Registrationcertificate（LegalizedbyEmbassyofParaguay）登记证（ICAMA）(使馆认证)3Identity基本信息1)Applicant2)Manufacturer3)Commonname:a

2、cceptedbyISO,orproposed,initsorder,byBSI,ANSI,WSSAorthemanufacturer,untilitsacceptanceordenominationbyISO.4)Synonymous5)ChemicalnameacceptedorproposedbyIUPAC6)NumberCAS7)Empiricalformula8)Structuralformula9)Numberofexperimentalcode10)Chemical(s)group(s

3、)11)Schematicdiagramofthemanufactureprocess12)Minimumcontentofactiveingredient13)Isomers14)Maximumlimitofeachpresentimpuritywhosecontentisequalorsuperiorto1g/kg(basedonthedataofanalysisoffivelotslikeminimum).Theimpuritiesmustbeidentifiedandbequantified

4、.Theidentifiedfractionoftheactivesubstancechemicaltechnicaldegreedoesnothavetosurpassthe20g/kg.15)Maximumlimitofeachexcellentimpuritywhosecontentisinferiorto1g/kg16)Additives(ej.:estabilizantes)1)申请人2)制造商3)通用名4)同义的名称5)IUPAC命名6)CAS号7)经验式8)化学式9)实验代码10)化学

5、组11)生产工艺的原理图12)活性成分的最低含量13)异构体14)含量大于等于1g/kg的杂质的最大含量15)含量小于1g/kg的杂质的最大含量16)添加剂4GPSPositionOfTheMufacture工厂的地理坐标5Fivebatchreport5批次报告6Certificateofanalysis.分析单7Compositioncertificatesignedbytheresponsibleofthemanufacturercompany组成8Manufacturingprocess生产

6、工艺1)Nameandaddressofthemanufacturer.2)Generalcharacterizationoftheprocess.3)Diagramofmanufacturewiththedifferent1)生产商的名称和地址2)工艺的一般特征3)chemicalreactionsthatarehappeningduringtheprocess.1)Identificationoftheusedmaterialsfortheproductionoftheproduct.2)Des

7、criptionoftheusedequipment.3)Generaldescriptionoftheconditions(forexample:temperature,pressure,pH,humidity)thatarecontrolledduringtheprocess.4)Descriptionofpossiblereactionaftertheformulationprocessbetweenactiveingredientsobetweenthisandotherscomponent

8、softheformulationorthepackage.Possiblemigrationsofmaterialsofthepackageandtheproduct.生产工艺流程图（化学反应式）1)生产原料的鉴定2)设备的描述3)工艺中的各条件4)生产中的副反应及材料和产品的可能性迁移。9MSDSMSDS10ANALYTICALMETHOD（Analyticalmethodsforthecuali-quantitativedeterminationoftheact