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中英文双语专刊:农药生产许可管理办法

中华人民共和国农业部令2017年第4号

Ministry of Agriculture Order No. 4,2017


农药生产许可管理办法
Measures on the Management of the Pesticide Production License


第一章 总  则
Chapter I      General


第一条  为了规范农药生产行为,加强农药生产管理,保证农药产品质量,根据《农药管理条例》,制定本办法。
  Article 1 To regulate pesticide production practices, strengthen pesticide production management and ensure the quality of pesticides, the Measures on the Management of the Pesticide Production License (the Measures) is hereby developed in accordance with the Regulations on the Management of Pesticides.


第二条  本办法所称农药生产,包括农药原药(母药)生产、制剂加工或者分装。
  Article 2  The pesticide production referred to in the Measures includes the production of the TC (TK), formulation processing or repackaging.


第三条  农药生产许可的申请、审查、核发和监督管理,适用本办法。
  Article 3 The Measures shall apply to the application, review, issuance, supervision and management of a pesticide production license.


第四条  农业部负责监督指导全国农药生产许可管理工作,制定生产条件要求和审查细则。
  Article 4 The Ministry of Agriculture shall be responsible for the nationwide supervision and guidance regarding the management of a pesticide production license and establishment of production condition requirements and review rules.

省级人民政府农业主管部门(以下简称省级农业部门)负责受理申请、审查并核发农药生产许可证。
  The agricultural authorities under the provincial people’s government (hereinafter referred to as the agricultural authorities at the provincial level) shall be responsible for accepting, reviewing applications and issuing a pesticide production license.

县级以上地方农业部门应当加强本行政区域内的农药生产监督管理工作。
  Local agricultural authorities above the county level shall strengthen the supervision and management of a pesticide production license within their respective administrative areas.


第五条  农药生产许可实行一企一证管理,一个农药生产企业只核发一个农药生产许可证。
  Article 5  The pesticide production license shall be managed on the principle of one license for one enterprise, and a pesticide producer will be granted only one pesticide production license.


第六条  农药生产应当符合国家产业政策,不得生产国家淘汰的产品,不得采用国家淘汰的工艺、装置、原材料从事农药生产,不得新增国家限制生产的产品或者国家限制的工艺、装置、原材料从事农药生产。
  Article 6 Pesticide production shall comply with national industrial policies, and pesticide producers shall not produce products considered obsolete by the state, or use any technology, equipment or raw materials considered obsolete by the state during pesticide production, and shall not add the production of products restricted by the state, or add any technology, equipment or raw materials restricted by the state for the purpose of pesticide production.


第七条  各级农业部门应当加强农药生产许可信息化建设。农业部加快建设全国统一的农药管理信息平台,逐步实现农药生产许可证的申请、受理、审核、核发和打印在农药管理信息平台统一进行。地方农业部门应当及时上传、更新农药生产许可、监督管理等信息。
  Article 7 Agricultural authorities at all levels shall strengthen information-based management of a pesticide production license. The Ministry of Agriculture shall accelerate the creation of a uniform national pesticide management information platform, and gradually realize the uniform handling of pesticide production license applications, acceptances, reviews, issuances and printing through the pesticide management information platform. Local agricultural authorities shall timely upload and update pesticide production licenses, and details pertaining to supervision and management and other information in a timely manner.

 

第二章 申请与审查
Chapter II     Application and Review


第八条  从事农药生产的企业,应当具备下列条件:
  Article 8 Enterprises engaged in pesticide production shall meet the following requirements:

(一)符合国家产业政策;
  (I) comply with national industrial policies;

(二)有符合生产工艺要求的管理、技术、操作、检验等人员;
  (II) have in place management, technology, operations, inspection and special post personnel, etc. meeting the requirements of the production process;

(三)有固定的生产厂址;
  (III)  have in place a permanent production site;

(四)有布局合理的厂房,新设立化学农药生产企业或者非化学农药生产企业新增化学农药生产范围的,应当在省级以上化工园区内建厂;新设立非化学农药生产企业、家用卫生杀虫剂企业或者化学农药生产企业新增原药(母药)生产范围的,应当进入地市级以上化工园区或者工业园区;
  (IV) have in place reasonably arranged plants, and where a newly established chemical pesticide producer or non-chemical pesticide producer expands the production scope of chemical pesticide, it shall establish factories in a chemical industry park above the provincial level; where a newly established non-chemical pesticide producer, household hygienic insecticide producer or chemical pesticide producer increases the production scope of the TC (TK), they shall be located in a chemical industry park or industry park above the municipal level;

(五)有与生产农药相适应的自动化生产设备、设施,有利用产品可追溯电子信息码从事生产、销售的设施;
  (V) have in place automation production equipment and facilities suitable for the pesticide it produces, as well as the facilities used in production and sales with traceable product electronic information codes;

(六)有专门的质量检验机构,齐全的质量检验仪器和设备,完整的质量保证体系和技术标准;
  (VI) have in place a specialized quality testing organization, complete testing instruments and equipment, and integrated quality assurance system and technical standards;

(七)有完备的管理制度,包括原材料采购、工艺设备、质量控制、产品销售、产品召回、产品储存与运输、安全生产、职业卫生、环境保护、农药废弃物回收与处置、人员培训、文件与记录等管理制度;
  (VII) have in place a complete management system, including raw material procurement, processing equipment, quality control, product sales, product recall, product storage and transportation, production safety, occupational health, environmental protection, pesticide waste collection and disposal, staff training, documenting and recording, and other management systems.

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

安全生产、环境保护等法律、法规对企业生产条件有其他规定的,农药生产企业还应当遵守其规定,并主动接受相关管理部门监管。
  Where there are other requirements on the production conditions of enterprises regarding work safety and environmental protection laws and regulations, the pesticide producers shall comply with the requirements and consciously accept the supervision of relevant management authorities.


第九条  申请农药生产许可证的,应当向生产所在地省级农业部门提交以下材料:
  Article 9 The following materials shall be submitted to the local agricultural authority at the provincial level in the application for a pesticide production license:

(一)农药生产许可证申请书;
  (I) an application form for a pesticide production license;

(二)企业营业执照复印件;
  (II) a copy of the enterprise’s business license;

(三)法定代表人(负责人)身份证明及基本情况;
  (III) identity certificates and basic information of the legal representative (person in charge);

(四)主要管理人员、技术人员、检验人员简介及资质证件复印件,以及从事农药生产相关人员基本情况;
  (IV) copies of resumes and qualification certificates of main management personnel, technical personnel and inspection personnel, as well as basic information of relevant personnel engaged in pesticide production;

(五)生产厂址所在区域的说明及生产布局平面图、土地使用权证或者租赁证明;
  (V)  floor plan layout, land use or lease certificate of the production site;

(六)所申请生产农药原药(母药)或者制剂剂型的生产装置工艺流程图、生产装置平面布置图、生产工艺流程图和工艺说明,以及相对应的主要厂房、设备、设施和保障正常运转的辅助设施等名称、数量、照片;
  (VI) process charts for production devices of the TC (TK) or formulation types of the pesticides to be produced in the application, floor layout of production devices, process chart and process specification, as well as the name, quantity and pictures of the corresponding main plant, equipment and facilities and ancillary facilities ensuring normal operation;

(七)所申请生产农药原药(母药)或者制剂剂型的产品质量标准及主要检验仪器设备清单;
  (VII) product quality standards and the list of main test instruments and equipment for the TC (TK) or formulation types to be produced in the application;

(八)产品质量保证体系文件和管理制度;
  (VIII) product quality assurance files and files pertaining to the management system;

(九)按照产品质量保证体系文件和管理制度要求,所申请农药的三批次试生产运行原始记录;
  (IX) primary records of three batches of pesticides manufactured in a trial production and for which the application is made, in accordance with the requirements found in the product quality assurance documents and the management system;

(十)申请材料真实性、合法性声明;
  (X) authenticity and legitimacy statements for application data;

(十一)农业部规定的其他材料。
  (XI) other data specified by the Ministry of Agriculture.

申请材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 forms.


第十条  省级农业部门对申请人提交的申请材料,应当根据下列情况分别作出处理:
  Article 10 For the application data submitted by the applicant, the agricultural authorities at the provincial level shall treat them respectively based on the following circumstances:

(一)不需要取得农药生产许可的,即时告知申请者不予受理;
  (I) where no pesticide production license is required, the applicant shall be timely informed that the application is not accepted;

(二)申请材料存在错误的,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 correct it on site;

(三)申请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,逾期不告知的,自收到申请材料之日起即为受理;
  (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 site or within five working days; if the applicant is not informed within the aforesaid period, the application shall be deemed as accepted upon receipt of the application data;

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


第十一条  省级农业部门应当对申请材料书面审查和技术评审,必要时应当进行实地核查,自受理申请之日起二十个工作日内作出是否核发生产许可证的决定。符合条件的,核发农药生产许可证;不符合条件的,书面通知申请人并说明理由。
  Article 11 The agricultural authorities at the provincial level shall review in writing and conduct a technical assessment of the application data, and if necessary, carry out an on-the-spot investigation. The agricultural authorities shall make a decision on whether the production license should be issued within twenty working days upon acceptance. If the conditions are met, the pesticide production license shall be issued; if not, written notice indicating the reasons to the applicant shall be given.

技术评审可以组织农药管理、生产、质量控制等方面的专业人员进行,所需时间不计算许可期限内,不得超过九十日。
  The technical assessment may be conducted by professionals in the fields of pesticide management, production, quality control, etc., and the time needed is not included in the license term and shall not exceed ninety days.


第十二条  农药生产许可证式样及相关表格格式由农业部统一制定。
  Article 12 The pesticide production license pattern and the format of the forms will be uniformly determined by the Ministry of Agriculture.

农药生产许可证应当载明许可证编号、生产企业名称、统一社会信用代码、住所、法定代表人(负责人)、生产范围、生产地址、有效期等事项。
  The pesticide production license shall clearly indicate the license number, name of the producer, uniform social credit code, domicile, legal representative (person in charge), scope of production, production address, validity period, etc.

农药生产许可证编号规则为:农药生许+省份简称+顺序号(四位数)。
  The numbering format of the pesticide production license: pesticide production license + abbreviation of province + serial number (four numerals).

农药生产许可证的生产范围按照下列规定进行标注:
  The production scope of the pesticide production license shall be marked according to the following regulations:

(一)原药(母药)品种;
  (I) category of the TC (TK);

(二)制剂剂型,同时区分化学农药或者非化学农药。
  (II) formulation type, with the chemical pesticides and non-chemical pesticides distinguished.


第三章  变更与延续
Chapter III    Alteration and Renewal


第十三条  农药生产许可证有效期为五年。农药生产许可证有效期内,企业名称、住所、法定代表人(负责人)发生变化或者缩小生产范围的,应当自发生变化之日起三十日内向省级农业部门提出变更申请,并提交变更申请表和相关证明等材料。
  Article 13 The pesticide production license is valid for five years. In case of any change of name, domicile, legal representative (person in charge) of a pesticide producer or narrowing of production scope, an application for change shall be filed to the agricultural authority at the provincial level within thirty days from the date of change and related proof of materials shall also be submitted.

省级农业部门应当自受理申请之日起二十个工作日内作出审批决定。符合条件的,予以变更;不符合条件的,书面通知申请人并说明理由。
  The agricultural authority at the provincial level shall approve or disapprove an application for change upon acceptance within twenty working days. If the application is qualified, the change will be approved; if not, a written notice indicating the reasons will be given to the applicant.


第十四条  农药生产企业扩大生产范围或者改变生产地址的,应当按照本办法的规定重新申请农药生产许可证。化学农药生产企业改变生产地址的,还应当进入市级以上化工园区或者工业园区。
  Article 14 In case a pesticide producer expands the production scope or changes the production site, he or she shall apply for a new pesticide production license according to the Measures. In case of relocation, chemical pesticide producers shall be relocated into a chemical industry park or industrial park above the municipal level.

新增生产地址的,按新设立农药生产企业要求办理。

For a newly increased production site, it shall be subject to the requirements on newly established pesticide producers.


第十五条  农药生产许可证有效期届满,需要继续生产农药的,农药生产企业应当在有效期届满九十日前向省级农业部门申请延续。
  Article 15 If the production of a pesticide needs to continue upon expiration of the period of validity, the pesticide producer shall apply to the agricultural authority at the provincial level for renewal ninety days before the expiration.


第十六条  申请农药生产许可证延续的,应当提交申请书、生产情况报告等材料。省级农业部门对申请材料进行审查,未在规定期限内提交申请或者不符合农药生产企业条件要求的,不予延续。
  Article 16 For the application of a pesticide production license renewal, the producer shall submit the application form, production report and other materials. The agricultural authorities shall review the application data. Where the application is not filed within the specified time limit, or the conditions are not met, the renewal will not be approved.


第十七条  农药生产许可证遗失、损坏的,应当说明原因并提供相关证明材料,及时向所在地省级农业部门申请补发。
  Article 17 In case of loss or damage of the pesticide production license, the pesticide producer shall state the reasons and provide relevant supporting documents, as well as apply to a local agricultural authority at the provincial level for re-issuance.


第四章 监督检查
Chapter IV   Supervision and Inspection


第十八条  农药生产企业应当按照产品质量标准和生产许可证的规定组织生产,确保农药产品与登记农药一致,对农药产品质量负责。
  Article 18 Pesticide producers shall organize production in accordance with the product quality standards and provisions of the production license, ensue the pesticide products are consistent with those registered, and be responsible for the quality of pesticides they produce.

农药生产企业在其农药生产许可范围内,依据《农药管理条例》第十九条的规定,可以接受新农药研制者和其他农药生产企业的委托,加工或者分装农药;也可以接受向中国出口农药的企业委托,分装农药。
  Within the pesticide production license scope, pesticide producers may accept the entrustment of new pesticide developers and other pesticide producers to toll or repack pesticides, as well as the entrustment of enterprises exporting pesticide to China to repack pesticides according to Article 19 of the Regulations on the Management of Pesticides.


第十九条  农药生产企业应当在每季度结束之日起十五日内,将上季度生产销售数据上传至农业部规定的农药管理信息平台。委托加工、分装农药的,由委托方报送。
  Article 19 Pesticide producers shall upload production and sales data of the last quarter within fifteen days upon the end of each quarter to the pesticide management information platform specified by the Ministry of Agriculture. In case of tolling or subpacking of pesticides, the entrusting party shall be responsible for such reporting.


第二十条  县级以上地方农业部门应当加强对农药生产企业的监督检查,定期调查统计农药生产情况,建立农药生产诚信档案并予以公布。
  Article 20 The local agricultural authority above the county level shall strengthen the supervision and inspection of pesticide producers, conduct regular surveys and statistics on pesticide production, and establish pesticide production credit files and publish them.


第二十一条  有下列情形之一的,由省级农业部门依法吊销农药生产许可证:
  Article 21 Agricultural authorities at the provincial level shall withdraw a pesticide production license according to law, in the event of any of the following circumstances:

(一)生产假农药的;
  (I) a fake pesticide is produced;

(二)生产劣质农药情节严重的;
  (II) a sub-standard pesticide is produced (considered a severe circumstance);

(三)不再符合农药生产许可条件继续生产农药且逾期拒不整改或者整改后仍不符合要求的; 
  (III) the continued production of pesticides when no longer meeting the requirements of a pesticide production license, and refusal to rectify or still fail to satisfy the requirements after rectification;

(四)违反《农药管理条例》第五十三条、五十四条规定情形的;
  (IV) a violation of regulations specified in Article 53 and Article 54 of the Regulations on the Management of Pesticides;

(五)转让、出租、出借农药生产许可证的;
  (V)  due to a transfer, lease or loan of the pesticide production license;

(六)招用《农药管理条例》第六十三条第一款规定人员从事农药生产活动的;
  (VI) due to the employment of any personnel specified in Paragraph I, Article 63 of the Regulations on the Management of Pesticides for pesticide production activities;

(七)依法应当吊销农药生产许可证的其他情形。
  (VII) other circumstances where the pesticide production license shall be revoked according to law.


第二十二条  有下列情形之一的,由省级农业部门依法撤销农药生产许可证:
  Article 22 Agricultural authorities at the provincial level shall revoke a pesticide production license according to law, in the event of any of the following circumstances:

(一)发证机关工作人员滥用职权、玩忽职守作出准予农药生产许可决定的;
  (I) the decision of granting the pesticide production license is made by the personnel of the issuing authority through an abuse of powers or a neglect of their duties;

(二)发证机关违反法定程序作出准予农药生产许可决定的;
  (II) the decision for granting the pesticide production license is made by the issuing authority against legal procedures;

(三)发证机关对不具备申请资格或者不符合法定条件的申请人准予农药生产许可的;
  (III) the pesticide production license is granted by the issuing authority to an applicant who is unqualified or does not conform to the statutory requirements;

(四)申请人以欺骗、贿赂等不正当手段取得农药生产许可的;
  (IV) the applicant obtained the pesticide production license by fraud, bribery and other improper means;

(五)依法应当撤销农药生产许可的其他情形。
  (V) other circumstances where the pesticide production license shall be revoked according to law.


第二十三条  有下列情形之一的,由省级农业部门依法注销农药生产许可证:
  Article 23 In the event of any of the following circumstances, the original issuing authority shall cancel its pesticide production license according to law:

(一)企业申请注销的;
  (I) if the enterprise applies for cancellation;

(二)企业主体资格依法终止的;
  (II) if the qualifications of the subject are terminated according to law;

(三)农药生产许可有效期届满未申请延续的;
  (III) if the application for renewal is not filed upon expiration of the term of validity of the pesticide production license;

(四)农药生产许可依法被撤回、撤销、吊销的;
  (IV) if the pesticide production license is withdrawn, canceled or revoked according to law;

(五)依法应当注销的其他情形。
  (V) based on other circumstances where the license shall be canceled according to law.


第二十四条  有下列情形之一的,按未取得农药生产许可证处理:
  Article 24 Any pesticide producer shall be deemed as not validly holding a pesticide production license under any of the following circumstances:

(一)超过农药生产许可证有效期继续生产农药的;
  (I) if the continued production of pesticides is beyond the term of validity of the pesticide production license;

(二)超过农药生产许可范围生产农药的;
  (II) if the production of pesticides is beyond the scope of the pesticide production license;

(三)未经批准擅自改变生产地址生产农药的;
  (III) if the production of pesticides in other places is carried out without approval;

(四)委托已取得农药生产许可证的企业超过农药生产许可范围加工或者分装农药的;
  (IV) if an enterprise which has obtained the pesticide production license is entrusted to process or sub-package pesticides beyond the scope of the license;

(五)应当按照未取得农药生产许可证处理的其他情形。
  (V) other circumstances where the pesticide production license is deemed not obtained.


第二十五条  农业部加强对省级农业部门实施农药生产许可的监督检查,及时纠正农药生产许可审批中的违规行为。发现有关工作人员有违规行为的,应当责令改正;依法应当给予处分的,向其任免机关或者监察机关提出处分建议。
  Article 25 The Ministry of Agriculture shall strengthen supervision and inspection of pesticide business licensing management by agricultural authorities at the provincial level, and if any personnel is found violating rules, the personnel shall be ordered to correct such a violation, and if punishment shall be imposed according to the law, suggestions for punishment shall be made to the personnel’s appointment and removal agency or supervision agency.


第二十六条  县级以上农业部门及其工作人员有下列行为之一的,责令改正;对负有责任的领导人员和直接责任人员调查处理;依法给予处分;构成犯罪的,依法追究刑事责任:
  Article 26 Agricultural authorities above the county level and their personnel shall be ordered to remedy any of the following actions below. Those who bare such direct responsibility for any such actions shall be investigated. Punishment shall be meted out according to the law, and if the actions constitute a crime, they shall be held criminally liable. The actions include:

(一)不履行农药生产监督管理职责,所辖行政区域的违法农药生产活动造成重大损失或者恶劣社会影响;
  (I) a failure to perform pesticide production supervision and management duties, and if illegal pesticide production activities in their administrative region caused material loss or adverse social influence;

(二)对不符合条件的申请人准予生产许可或者对符合条件的申请人拒不准予生产许可;
  (II) granting a production license to any unqualified applicant, or withholding a production license to any qualified applicant;

(三)参与农药生产、经营活动;
  (III) being engaged in pesticide production and operation activities;

(四)有其他徇私舞弊、滥用职权、玩忽职守行为。
  (IV) playing favoritism and committing irregularities, abusing powers and neglecting duties.


第二十七条  任何单位和个人发现违法从事农药生产活动的,有权向农业部门举报,农业部门应当及时核实、处理,严格为举报人保密。经查证属实,并对生产安全起到积极作用或者挽回损失较大的,按照国家有关规定予以表彰或者奖励。
  Article 27 If any unit or individual finds any one is engaged in pesticide production activities in violation of the law, it has the right to report the violation to the agricultural authority, and the agricultural authority shall verify such reporting, deal with the issue in a timely manner, and keep confidential the information of the informer. If the case is verified to be true and plays an active role in production safety or saves great loss, a reward or award shall be given according to relevant national regulations.


第二十八条  农药生产企业违法从事农药生产活动的,按照《农药管理条例》的规定处罚;构成犯罪的,依法追究刑事责任。
  Article 28 If a pesticide producer is engaged in illegal pesticide production activities, it shall be punished according to the stipulations in the Regulations on the Management of Pesticides; if the aforesaid activities constitute a crime, the pesticide producer shall he held criminally liable according to law.


第五章  附则
Chapter V    Supplementary Provisions


第二十九条  本办法中化学农药是指利用化学物质人工合成的农药。
  Article 29 Chemical pesticides mentioned in the Measures refer to pesticides artificially synthesized with chemical substances.


第三十条  本办法自2017年8月1日起实施。
  Article 30 The Measures will come into force from August 1, 2017.

在本办法实施前已取得农药生产批准证书或者农药生产许可证的农药生产企业,可以在有效期内继续生产相应的农药产品。有效期届满,需要继续生产农药的,农药生产企业应当在有效期届满九十日前,按照本办法的规定,向省级农业部门申请农药生产许可证。
  If any pesticide producer has obtained a production approval certificate or license before the Measures come into effect, it is allowed to continue such production of corresponding pesticides within the validity term. Where the production of pesticides needs to continue upon expiration of the term of validity, the pesticide producer shall apply for a new pesticide production license at the agricultural authority of the provincial level ninety days before expiration of the term of validity in accordance with the Measures.

在本办法实施前已取得农药登记证但未取得农药生产批准证书或者农药生产许可证,需要继续生产农药的,应当在本办法实施之日起两年内取得农药生产许可证。

If any pesticide producer which has obtained a pesticide registration certificate, but not the approval certificate for pesticide production or a pesticide production license before the implementation of the Measures and needs to continue the production of pesticides, it shall obtain a pesticide production license within two years after the implementation of the Measures.

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