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中英文双语专刊:农药经营许可管理办法

中华人民共和国农业部令2017年第6号

Ministry of Agriculture Order No. 6,2017


农药登记试验管理办法
Measures on the Management of Pesticide Registration Tests


第一章  总则
Chapter I      General


第一条  为了保证农药登记试验数据的完整性、可靠性和真实性,加强农药登记试验管理,根据《农药管理条例》,制定本办法。
  Article 1 To ensure the completeness, reliability and authenticity of pesticide registration tests and strengthen pesticide registration test management, the Measures on the Management of Pesticide Registration Tests (the Measures) is hereby developed in accordance with the Regulations on the Management of Pesticides.


第二条  申请农药登记的,应当按照本办法进行登记试验。
  Article 2 For the application of pesticide registration, registration tests shall be performed according to the Measures.

开展农药登记试验的,申请人应当报试验所在地省级人民政府农业主管部门(以下简称省级农业部门)备案;新农药的登记试验,还应当经农业部审查批准。
  For pesticide registration tests, the applicant shall report to the agricultural authority under the provincial people’s government (hereinafter referred to as agricultural authority at the provincial level) where it is to be put on record; the registration tests for new pesticides shall be additionally subject to review and approval of the Ministry of Agriculture.


第三条  农业部负责新农药登记试验审批、农药登记试验单位认定及登记试验的监督管理,具体工作由农业部所属的负责农药检定工作的机构承担。
  Article 3 The Ministry of Agriculture shall be responsible for approval of new pesticide registration tests, recognition of pesticide registration test entities, supervision and management of registration tests; specific issues shall be handled by the institution responsible for the pesticide examination institute under the Ministry of Agriculture.

省级农业部门负责本行政区域的农药登记试验备案及相关监督管理工作,具体工作由省级农业部门所属的负责农药检定工作的机构承担。
  The agricultural authorities at the provincial level shall be responsible for relevant supervision and management work within their respective administrative areas; and specific issues shall be handled by the institution responsible for the pesticide examination institute under the Ministry of Agriculture.


第四条  省级农业部门应当加强农药登记试验监督管理信息化建设,及时将登记试验备案及登记试验监督管理信息上传至农业部规定的农药管理信息平台。
  Article 4 Agricultural authorities at the provincial level shall further digitalize the supervision and management, of the pesticide registration test, and timely upload the registration test record and supervision information to the pesticide management information platform specified by the Ministry of Agriculture.


第二章  试验单位认定
Chapter II     Recognition of Test Entities


第五条  申请承担农药登记试验的机构,应当具备下列条件:
  Article 5 An entity which applies for undertaking pesticide registration test shall meet all the conditions below:

(一)具有独立的法人资格,或者经法人授权同意申请并承诺承担相应法律责任;
  (I) be an independent legal person, or individual authorized by the legal person to file such an application and commits to assume corresponding legal liabilities;

(二)具有与申请承担登记试验范围相匹配的试验场所、环境设施条件、试验设施和仪器设备、样品及档案保存设施等;
  (II) has its own testing place, suitable environment and facilities, test equipment and instruments, sample and file storage facilities, etc. matching the scope of the registration test for which it applies;

(三)具有与其确立了合法劳动或者录用关系,且与其所申请承担登记试验范围相适应的专业技术和管理人员;
  (III) has professional technicians and management who are in legal labor or an employment relationship with it and able to undertake the registration tests within the scope for which it has applied for;

(四)建立完善的组织管理体系,配备机构负责人、质量保证部门负责人、试验项目负责人、档案管理员、样品管理员和相应的试验与工作人员等;
  (IV) has a sound organization management system as well as persons in charge, a head of quality assurance, test project manager, file clerk, sample managers, corresponding testing personnel and other employees;

(五)符合农药登记试验质量管理规范,并制定了相应的标准操作规程;
  (V) complies with quality management regulations for pesticide registration tests, and corresponding standard operation procedures are established; and

(六)有完成申请试验范围相关的试验经历,并按照农药登记试验质量管理规范运行六个月以上;
  (VI) has sufficient experience in completing the test within the scope for which it applied for, and has been operating for more than 6 months in accordance with quality management regulations for pesticide registration tests;

(七)农业部规定的其他条件。
  (VII) meets other conditions specified by the Ministry of Agriculture.

第六条  申请承担农药登记试验的机构应当向农业部提交以下资料:
  Article 6  The entity which applies for undertaking pesticide registration tests shall submit the following documents to the Ministry of Agriculture:

(一)农药登记试验单位考核认定申请书;
  (I) an application form for examination and recognition of the pesticide registration test entity;

(二)法人资格证明复印件,或者法人授权书;
  (II) a copy of legal person certificate or power of attorney issued by a legal person;

(三)组织机构设置与职责;
  (III) organizational structure setting and responsibilities;

(四)试验机构质量管理体系文件(标准操作规程)清单;
  (IV) list of quality management system documents (standard operation procedures) of the test entity;

(五)试验场所、试验设施、实验室等证明材料以及仪器设备清单;
  (V) supporting evidence for test place, test facilities and labs, and list of instruments and equipment;

(六)专业技术和管理人员名单及相关证明材料;
  (VI) list of professional technicians and management and relevant supporting documents;

(七)按照农药登记试验质量管理规范要求运行情况的说明,典型试验报告及其相关原始记录复印件。
  (VII) statement of operations in compliance with quality management regulations for pesticide registration tests as well as typical test reports and copy of its original record.

申请资料应当同时提交纸质文件和电子文档。
  The application data shall be submitted in both paper and electronic form.


第七条 农业部对申请人提交的资料进行审查,材料不齐全或者不符合法定形式的,应当当场或者在五个工作日内一次告知申请者需要补正的全部内容;申请资料齐全、符合法定形式,或者按照要求提交全部补正资料的,予以受理。
  Article 7 Where the application data submitted by the applicant is not complete or consistent with legal forms upon examination by the Ministry of Agriculture, the applicant shall be informed of all the contents that should be corrected or supplemented once and for all on the spot where the applicant submits his/her application or within five working days; where the application data are complete and consistent with legal forms, and all the supplemented or corrected data are submitted as required, the application shall be accepted.


第八条  农业部对申请资料进行技术评审,所需时间不计算审批期限内,不得超过六个月。
  Article 8  The Ministry of Agriculture shall finish its technical review within six months upon the date of acceptance, excluding the approval period.


第九条  技术评审包括资料审查和现场检查。
  Article 9 The technical review includes data review and field inspections.

资料审查主要审查申请人组织机构、试验条件与能力匹配性、质量管理体系及相关材料的完整性、真实性和适宜性。
  Data review includes the applicant’s organizational structure, test conditions, capacity suitability as well as the completeness, authenticity and suitability of quality management systems and relevant materials.

现场检查主要对申请人质量管理体系运行情况、试验设施设备条件、试验能力等情况进行符合性检查。
  Field inspections include a compliance inspection of the applicant’s implementation of quality management systems, the conditions of test equipment and facilities as well as testing capacities.

具体评审规则由农业部另行制定。
  Detailed review rules shall be separately established by the Ministry of Agriculture.


第十条  农业部根据评审结果在二十个工作日内作出审批决定,符合条件的,颁发农药登记试验单位证书;不符合条件的,书面通知申请人并说明理由。
  Article 10 The Ministry of Agriculture shall within twenty working days state its approval or disapproval based on assessment results. If the conditions are met, the Ministry of Agriculture shall issue the pesticide registration test entity certificate, and if not, give a written notice indicating the reasons to the applicant.


第十一条  农药登记试验单位证书有效期为五年,应当载明试验单位名称、法定代表人(负责人)、住所、实验室地址、试验范围、证书编号、有效期等事项。
  Article 11 The pesticide registration test entity certificate is valid for five years and shall indicate the full name, legal representative (person in charge), domicile, location of laboratory, testing scope, certificate number, validity and other details about the test entity.


第十二条  农药登记试验单位证书有效期内,农药登记试验单位名称、法定代表人(负责人)名称或者住所发生变更的,应当向农业部提出变更申请,并提交变更申请表和相关证明等材料。农业部应当自受理变更申请之日起二十个工作日内作出变更决定。
  Article 12     Within the validity of the pesticide registration test entity certificate, in case of any change to the name of the pesticide registration test entity, the name or domicile of the legal representative (person in charge), an application for such change shall be filed to the Ministry of Agriculture, together with an application form for change and other supporting documents. The Ministry of Agriculture shall approve or disapprove the change within twenty working days upon acceptance of the application.


第十三条  农药登记试验单位证书有效期内,有下列情形之一的,应当向农业部重新申请:
  Article 13 Within the validity of the pesticide registration test entity certificate, in the event of any of the following circumstances, a re-application shall be made to the Ministry of Agriculture:

(一)试验单位机构分设或者合并的;
  (I) the testing entity is divided or merged;

(二)实验室地址发生变化或者设施条件发生重大变化的;
  (II) any changeto the location of the laboratory or any major change to facilities occurs; or

(三)试验范围增加的;
  (III) the test scope is expanded;

(四)其他事项。
  (IV) others.


第十四条  农药登记试验单位证书有效期届满,需要继续从事农药登记试验的,应当在有效期届满六个月前,向农业部重新申请。
  Article 14     Upon expiration of the validity of the pesticide registration test entity certificate, if the test entity intends to continue pesticide registration testing, it shall re-apply to the Ministry of Agriculture at least six months prior to such expiration.


第十五条  农药登记试验单位证书遗失、损坏的,应当说明原因并提供相关证明材料,及时向农业部申请补发。
  Article 15     If the pesticide registration test entity certificate is lost or damaged, the entity shall state the reasons, provide relevant supporting documents, and apply to the Ministry of Agriculture for re-issuance in a timely manner.


第三章  试验备案与审批
Chapter III Test Filing and Approval


第十六条  开展农药登记试验之前,申请人应当向登记试验所在地省级农业部门备案。备案信息包括备案人、产品概述、试验项目、试验地点、试验单位、试验时间、安全防范措施等。
  Article 16     Before any pesticide registration test to be conducted, the test shall be recorded with the agricultural authority at the provincial level where the registration test will be carried out, stating the filer, product description, test items, test site, test entity, test time, safety protection measures, etc.


第十七条  开展新农药登记试验的,应当向农业部提出申请,并提交以下资料:
  Article 17 Where any new pesticide registration test needs to be carried out, an application shall be submitted to the Ministry of Agriculture with the following documents accompanied:

(一)新农药登记试验申请表;
  (I) new pesticide registration test application form;

(二)境内外研发及境外登记情况;
  (II) domestic and foreignR&D and foreign registration;

(三)试验范围、试验地点(试验区域)及相关说明;
  (III) scope of test, test site (test area) and other statements;

(四)产品化学信息及产品质量符合性检验报告;
  (IV) chemical information of product and a product quality conformance inspection report;

(五)毒理学信息;
  (V)  toxicological information;

(六)作物安全性信息;
  (VI) crop safety information;

(七)环境安全信息;
  (VII)  environmental safety information;

(八)试验过程中存在或者可能存在的安全隐患;
  (VIII) existing or potential safety hazards in the test;

(九)试验过程需要采取的安全性防范措施;
  (IX) safety protection measures to be taken in the test;

(十)申请人身份证明文件。
  (X)  identity documents of the applicant.

申请资料应当同时提交纸质文件和电子文档。
  The application data shall be accompanied with paper and electronic files.


第十八条  农业部对申请人提交的申请资料,应当根据下列情况分别作出处理:
  Article 18 Regarding the application data submitted by the applicant, the Ministry of Agriculture shall treat them based on the following circumstances:

(一)农药登记试验不需要批准的,即时告知申请者不予受理;
  (I) where no approval is required for the pesticide registration test, the applicant shall be informed in a timely manner that the application is not accepted;

(二)申请资料存在错误的,允许申请者当场更正;
  (II) where any error is found in the application data, the applicant shall be allowed to make any correction on site;

(三)申请资料不齐全或者不符合法定形式的,应当当场或者在五个工作日内一次告知申请者需要补正的全部内容,逾期不告知的,自收到申请资料之日起即为受理;
  (III)  where the application data is not complete or consistent with legal forms, the applicant shall be informed of all the contents that should be corrected or supplemented once and for all on the spot where the applicant submits his/her application or within five working days; if the applicant is not informed within the aforesaid period, the data is deemed as accepted upon receipt of the application data;

(四)申请资料齐全、符合法定形式,或者申请者按照要求提交全部补正资料的,予以受理。
  (IV) where the application data are complete, consistent with legal forms, or the applicant submits all supplemental or corrected data as required, the application shall be accepted.


第十九条  农业部应当自受理之日起四十个工作日内对试验安全风险及其防范措施进行审查,作出审批决定。符合条件的,准予登记试验,颁发新农药登记试验批准证书;不符合条件的,书面通知申请人并说明理由。
  Article 19 Within forty working days upon acceptance of the application, the Ministry of Agriculture shall examine the test’s safety risks and prevention measures and make a decision on its approval or disapproval. If the conditions are met, the Ministry of Agriculture shall approve the registration test and issue a new pesticide registration test approval certificate, and if not, give a written notice to the applicant indicating the reasons.


第二十条  新农药登记试验批准证书应当载明试验申请人、农药名称、剂型、有效成分及含量、试验范围,试验证书编号及有效期等事项。
  Article 20 The new pesticide registration test approval certificate shall clearly state the name of the test applicant, pesticide name, fomulation type, active ingredients and content, test scope, test certificate number, validity period and others.

新农药登记试验批准证书式样由农业部制定。证书编号规则为“SY+年号+顺序号”,年号为证书核发年份,用四位阿拉伯数字表示;顺序号用三位阿拉伯数字表示。
  The type of new pesticide registration test approval certificate will be determined by the Ministry of Agriculture. The certificate number shall be expressed as “SY + Year + Serial No”; “Year” means the year in which the certificate is issued and shall be expressed by four Arabic numerals; the serial number shall be expressed by three Arabic numerals.

新农药登记试验批准证书有效期五年。五年之内未开展试验的,应当重新申请。
  The new pesticide registration test approval certificate is valid for five years. If no test is carried out within five years, a re-application shall be made.

 

第四章  登记试验基本要求
Chapter IV   Basic Requirements for Registration Tests


第二十一条  农药登记试验样品应当是成熟定型的产品,具有产品鉴别方法、质量控制指标和检测方法。
  Article 21 The sample of the pesticide registration test shall be a sophisticated finished product and accompanied with product identification methods, quality control indicators and testing methods.

申请人应当对试验样品的真实性和一致性负责。
  The applicant shall be responsible for the authenticity and consistency of the test sample.


第二十二条  申请人应当将试验样品提交所在地省级农药检定机构进行封样,提供农药名称、有效成分及其含量、剂型、样品生产日期、规格与数量、储存条件、质量保证期等信息,并附具产品质量符合性检验报告及相关谱图。
  Article 22     The applicant shall submit the test sample to the Provincial Pesticide Examination Institution where it is located for sealing, and provide the pesticide name, active ingredients and contents, dosage form, sample production date, specifications and quantity, storage conditions, warranty period and other information together with a quality consistency test report and relevant spectrogram.


第二十三条  所封试验样品由省级农药检定机构和申请人各留存一份,保存期限不少于两年,其余样品由申请人送至登记试验单位开展试验。
  Article 23 The sealed test samples shall be retained by the Provincial Pesticide Examination Institution and the applicant, one for each, for at least two years, and the remained samples shall be sent to the registration test entity for testing.


第二十四条  封存试验样品不足以满足试验需求或者试验样品已超过保存期限,仍需要进行试验的,申请人应当按本办法规定重新封存样品。
  Article 24 Where the sealed test samples are insufficient for testing needs or the storage life has lapsed for the test samples, if it is still necessary to carry out the test, the applicant shall re-seal the samples according to the Measures.


第二十五条  申请人应当向农药登记试验单位提供试验样品的农药名称、含量、剂型、生产日期、储存条件、质量保证期等信息及安全风险防范措施。属于新农药的,还应当提供新农药登记试验批准证书复印件。
  Article 25 The applicant shall provide the pesticide registration test entity with the information regarding the pesticide test sample’s name, content, dosage form, production date, storage conditions, quality warranty period as well as risk prevention measures. In case of a new pesticide, the copy of a new pesticide registration test approval certificate shall also be provided.

农药登记试验单位应当查验封样完整性、样品信息符合性。
  The pesticide registration test entity shall check for the completeness of sealed samples and the compliance of sample information.


第二十六条  农药登记试验单位接受申请人委托开展登记试验的,应当与申请人签订协议,明确双方权利与义务。
  Article 26 If the pesticide registration test entity is engaged by the applicant to carry out the registration test, the entity shall enter into an agreement with the applicant to define their rights and obligations.


第二十七条  农药登记试验应当按照法定农药登记试验技术准则和方法进行。尚无法定技术准则和方法的,由申请人和登记试验单位协商确定,且应当保证试验的科学性和准确性。
  Article 27 The pesticide registration test shall be carried out according to legal technical standards and methods for pesticide registration tests. In absence of such legal technical standards and methods, they shall be determined by the applicant and the registration test entity through consultation with the scientific soundness and accuracy of the tests guaranteed.

农药登记试验过程出现重大安全风险时,试验单位应当立即停止试验,采取相应措施防止风险进一步扩大,并报告试验所在地省级农业部门,通知申请人。
  In cases where any material safety risks occurs in the process of the pesticide registration test, the test entity shall immediately cease the test and take all reasonable measures to prevent further expansion of risk, report such case to the agricultural authority at the provincial level where it is located, and notify the applicant.


第二十八条  试验结束后,农药登记试验单位应当按照协议约定,向申请人出具规范的试验报告。
  Article 28 Upon completion of the test, the pesticide registration test entity shall issue a standard test report to the applicant as agreed upon in the agreement.


第二十九条  农药登记试验单位应当将试验计划、原始数据、标本、留样被试物和对照物、试验报告及与试验有关的文字材料保存至试验结束后至少七年,期满后可移交申请人保存。申请人应当保存至农药退市后至少五年。
  Article 29 The pesticide registration test entity shall keep the test plan, original data, specimen, tested samples and contrasts, test report and other documentary materials regarding the test for at least seven years after completion of the test, and may hand over the same material to the applicant upon expiry of the period. The applicant shall keep the material for at least five years after the pesticide is withdrawn from the market.

质量容易变化的标本、被试物和对照物留样样品等,其保存期应以能够进行有效评价为期限。
  The storage life of perishable specimen, tested samples, contrast samples, etc. shall be subject to a period of effective evaluation.

试验单位应当长期保存组织机构、人员、质量保证部门检查记录、主计划表、标准操作规程等试验机构运行与质量管理记录。
  The test entity shall keep indefinitely the organizational structure, personnel, quality assurance department check record, master schedule, standard operation instructions and other records regarding operation activities and quality management of the test entity.

 

第五章  监督检查
Chapter V    Supervision and Inspection


第三十条  省级农业部门、农业部对农药登记试验单位和登记试验过程进行监督检查,重点检查以下内容:
  Article 30 The agricultural authority at the provincial level and the Ministry of Agriculture shall supervise and inspect the pesticide registration test entities and the registration test process, and focus on the following items:

(一)试验单位资质条件变化情况;
  (I) change of the qualification conditions of the test entities;

(二)重要试验设备、设施情况;
  (II) important test equipment and facilities;

(三)试验地点、试验项目等备案信息是否相符;
  (III) whether the test site, test items and other recorded information are consistent;

(四)试验过程是否遵循法定的技术准则和方法;
  (IV) whether the test process is consistent with statutory technical rules and methods;

(五)登记试验安全风险及其防范措施的落实情况;
  (V) the safety risks of registration tests and the implementation of their prevention measures;

(六)其他不符合农药登记试验质量管理规范要求或者影响登记试验质量的情况。
  (VI) other circumstances where the quality management specification requirements on pesticide registration tests are not met or the registration test quality is affected.

发现试验过程存在难以控制安全风险的,应当及时责令停止试验或者终止试验,并及时报告农业部。
  In case any uncontrollable safety risk is found in the test process, the test shall be promptly ordered to cease or terminate and a risk report sent to the Ministry of Agriculture.

发现试验单位不再符合规定条件的,应当责令改进或者限期整改,逾期拒不整改或者整改后仍达不到规定条件的,由农业部撤销其试验单位证书。
  In case any test entity is found no longer consistent with the specified conditions, the authority shall call for corrections to be made within a specified period; if the test entity refuses to make the corrections or fails to meet the requirements even after correction, the Ministry of Agriculture will revoke the test entity’s testing certificate.


第三十一条  农药登记试验单位应当每年向农业部报送本年度执行农药登记试验质量管理规范的报告。
  Article 31 The pesticide registration test entities shall submit reports on implementation of quality management regulations for pesticide registration tests to the Ministry of Agriculture each year.


第三十二条  省级以上农业部门应当组织对农药登记试验所封存的农药试验样品的符合性和一致性进行监督检查,并及时将监督检查发现的问题报告农业部。
  Article 32 Agricultural authorities above the provincial level shall arrange for supervision and inspection on the conformity and consistency of pesticide test samples sealed for registration tests, and report any problem found during supervision and inspection to the Ministry of Agriculture.


第三十三条 农药登记试验单位出具虚假登记试验报告的,依照《农药管理条例》第五十一条的规定处罚。
  Article 33 If the pesticide registration test entity issues any false registration test report, it shall be subject to sanctions according to Article 51 of the Regulations on the Management of Pesticides.


第六章  附则
Chapter VI   Supplementary Provisions


第三十四条  现有农药登记试验单位无法承担的试验项目,由农业部指定的单位承担。
  Article 34 Test items in which the existing registration test entities are unable to undertake shall be undertaken by the entity designated by the Ministry of Agriculture.


第三十五条  本办法自2017年8月1日起施行。
  Article 35 The Measures shall be enacted as from August 1, 2017.

在本办法施行前农业部公布的农药登记试验单位,在有效期内可继续从事农药登记试验;有效期届满,需要继续从事登记试验的,应当按照本办法的规定申请试验单位认定。
  The pesticide registration test entities announced publicly by the Ministry of Agriculture prior to the enactment of the Measures may continue pesticide registration tests within their validity terms; where the registration tests need to be continued after the expiration of the validity term, an application for recognition of the test entity shall be filed according to the Measures.

中华人民共和国农业部令2017年第6号

Ministry of Agriculture Order No. 6,2017


农药登记试验管理办法
Measures on the Management of Pesticide Registration Tests


第一章  总则
Chapter I      General


第一条  为了保证农药登记试验数据的完整性、可靠性和真实性,加强农药登记试验管理,根据《农药管理条例》,制定本办法。
  Article 1 To ensure the completeness, reliability and authenticity of pesticide registration tests and strengthen pesticide registration test management, the Measures on the Management of Pesticide Registration Tests (the Measures) is hereby developed in accordance with the Regulations on the Management of Pesticides.


第二条  申请农药登记的,应当按照本办法进行登记试验。
  Article 2 For the application of pesticide registration, registration tests shall be performed according to the Measures.

开展农药登记试验的,申请人应当报试验所在地省级人民政府农业主管部门(以下简称省级农业部门)备案;新农药的登记试验,还应当经农业部审查批准。
  For pesticide registration tests, the applicant shall report to the agricultural authority under the provincial people’s government (hereinafter referred to as agricultural authority at the provincial level) where it is to be put on record; the registration tests for new pesticides shall be additionally subject to review and approval of the Ministry of Agriculture.


第三条  农业部负责新农药登记试验审批、农药登记试验单位认定及登记试验的监督管理,具体工作由农业部所属的负责农药检定工作的机构承担。
  Article 3 The Ministry of Agriculture shall be responsible for approval of new pesticide registration tests, recognition of pesticide registration test entities, supervision and management of registration tests; specific issues shall be handled by the institution responsible for the pesticide examination institute under the Ministry of Agriculture.

省级农业部门负责本行政区域的农药登记试验备案及相关监督管理工作,具体工作由省级农业部门所属的负责农药检定工作的机构承担。
  The agricultural authorities at the provincial level shall be responsible for relevant supervision and management work within their respective administrative areas; and specific issues shall be handled by the institution responsible for the pesticide examination institute under the Ministry of Agriculture.


第四条  省级农业部门应当加强农药登记试验监督管理信息化建设,及时将登记试验备案及登记试验监督管理信息上传至农业部规定的农药管理信息平台。
  Article 4 Agricultural authorities at the provincial level shall further digitalize the supervision and management, of the pesticide registration test, and timely upload the registration test record and supervision information to the pesticide management information platform specified by the Ministry of Agriculture.


第二章  试验单位认定
Chapter II     Recognition of Test Entities


第五条  申请承担农药登记试验的机构,应当具备下列条件:
  Article 5 An entity which applies for undertaking pesticide registration test shall meet all the conditions below:

(一)具有独立的法人资格,或者经法人授权同意申请并承诺承担相应法律责任;
  (I) be an independent legal person, or individual authorized by the legal person to file such an application and commits to assume corresponding legal liabilities;

(二)具有与申请承担登记试验范围相匹配的试验场所、环境设施条件、试验设施和仪器设备、样品及档案保存设施等;
  (II) has its own testing place, suitable environment and facilities, test equipment and instruments, sample and file storage facilities, etc. matching the scope of the registration test for which it applies;

(三)具有与其确立了合法劳动或者录用关系,且与其所申请承担登记试验范围相适应的专业技术和管理人员;
  (III) has professional technicians and management who are in legal labor or an employment relationship with it and able to undertake the registration tests within the scope for which it has applied for;

(四)建立完善的组织管理体系,配备机构负责人、质量保证部门负责人、试验项目负责人、档案管理员、样品管理员和相应的试验与工作人员等;
  (IV) has a sound organization management system as well as persons in charge, a head of quality assurance, test project manager, file clerk, sample managers, corresponding testing personnel and other employees;

(五)符合农药登记试验质量管理规范,并制定了相应的标准操作规程;
  (V) complies with quality management regulations for pesticide registration tests, and corresponding standard operation procedures are established; and

(六)有完成申请试验范围相关的试验经历,并按照农药登记试验质量管理规范运行六个月以上;
  (VI) has sufficient experience in completing the test within the scope for which it applied for, and has been operating for more than 6 months in accordance with quality management regulations for pesticide registration tests;

(七)农业部规定的其他条件。
  (VII) meets other conditions specified by the Ministry of Agriculture.

第六条  申请承担农药登记试验的机构应当向农业部提交以下资料:
  Article 6  The entity which applies for undertaking pesticide registration tests shall submit the following documents to the Ministry of Agriculture:

(一)农药登记试验单位考核认定申请书;
  (I) an application form for examination and recognition of the pesticide registration test entity;

(二)法人资格证明复印件,或者法人授权书;
  (II) a copy of legal person certificate or power of attorney issued by a legal person;

(三)组织机构设置与职责;
  (III) organizational structure setting and responsibilities;

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