易制毒化学品管理条例
总理 温家宝
二00五年八月二十六日
易制毒化学品管理条例
第一章 总 则
第一条 为了加强易制毒化学品管理，规范易制毒化学品的生产、经营、购买、运输和进口、出口行为，防止易制毒化学品被用于制造毒品，维护经济和社会秩序，制定本条例。
第二条 国家对易制毒化学品的生产、经营、购买、运输和进口、出口实行分类管理和许可制度。
易制毒化学品分为三类。第一类是可以用于制毒的主要原料，第二类、第三类是可以用于制毒的化学配剂。易制毒化学品的具体分类和品种，由本条例附表列示。
易制毒化学品的分类和品种需要调整的，由国务院公安部门会同国务院食品药品监督管理部门、安全生产监督管理部门、商务主管部门、卫生主管部门和海关总署提出方案，报国务院批准。
省、自治区、直辖市人民政府认为有必要在本行政区域内调整分类或者增加本条例规定以外的品种的，应当向国务院公安部门提出，由国务院公安部门会同国务院有关行政主管部门提出方案，报国务院批准。
第三条 国务院公安部门、食品药品监督管理部门、安全生产监督管理部门、商务主管部门、卫生主管部门、海关总署、价格主管部门、铁路主管部门、交通主管部门、工商行政管理部门、环境保护主管部门在各自的职责范围内，负责全国的易制毒化学品有关管理工作；县级以上地方各级人民政府有关行政主管部门在各自的职责范围内，负责本行政区域内的易制毒化学品有关管理工作。
县级以上地方各级人民政府应当加强对易制毒化学品管理工作的领导，及时协调解决易制毒化学品管理工作中的问题。
第四条 易制毒化学品的产品包装和使用说明书，应当标明产品的名称（含学名和通用名）、化学分子式和成分。
第五条 易制毒化学品的生产、经营、购买、运输和进口、出口，除应当遵守本条例的规定外，属于药品和危险化学品的，还应当遵守法律、其他行政法规对药品和危险化学品的有关规定。
禁止走私或者非法生产、经营、购买、转让、运输易制毒化学品。
禁止使用现金或者实物进行易制毒化学品交易。但是，个人合法购买第一类中的药品类易制毒化学品药品制剂和第三类易制毒化学品的除外。
生产、经营、购买、运输和进口、出口易制毒化学品的单位，应当建立单位内部易制毒化学品管理制度。
第六条 国家鼓励向公安机关等有关行政主管部门举报涉及易制毒化学品的违法行为。接到举报的部门应当为举报者保密。对举报属实的，县级以上人民政府及有关行政主管部门应当给予奖励。
第二章 生产、经营管理
第七条 申请生产第一类易制毒化学品，应当具备下列条件，并经本条例第八条规定的行政主管部门审批，取得生产许可证后，方可进行生产：
（一）属依法登记的化工产品生产企业或者药品生产企业；
（二）有符合国家标准的生产设备、仓储设施和污染物处理设施；
（三）有严格的安全生产管理制度和环境突发事件应急预案；
（四）企业法定代表人和技术、管理人员具有安全生产和易制毒化学品的有关知识，无毒品犯罪记录；
（五）法律、法规、规章规定的其他条件。
申请生产第一类中的药品类易制毒化学品，还应当在仓储场所等重点区域设置电视监控设施以及与公安机关联网的报警装置。
第八条 申请生产第一类中的药品类易制毒化学品的，由国务院食品药品监督管理部门审批；申请生产第一类中的非药品类易制毒化学品的，由省、自治区、直辖市人民政府安全生产监督管理部门审批。
前款规定的行政主管部门应当自收到申请之日起60日内，对申请人提交的申请材料进行审查。对符合规定的，发给生产许可证，或者在企业已经取得的有关生产许可证件上标注；不予许可的，应当书面说明理由。
审查第一类易制毒化学品生产许可申请材料时，根据需要，可以进行实地核查和专家评审。
第九条 申请经营第一类易制毒化学品，应当具备下列条件，并经本条例第十条规定的行政主管部门审批，取得经营许可证后，方可进行经营：
（一）属依法登记的化工产品经营企业或者药品经营企业；
（二）有符合国家规定的经营场所，需要储存、保管易制毒化学品的，还应当有符合国家技术标准的仓储设施；
（三）有易制毒化学品的经营管理制度和健全的销售网络；
（四）企业法定代表人和销售、管理人员具有易制毒化学品的有关知识，无毒品犯罪记录；
（五）法律、法规、规章规定的其他条件。
第十条 申请经营第一类中的药品类易制毒化学品的，由国务院食品药品监督管理部门审批；申请经营第一类中的非药品类易制毒化学品的，由省、自治区、直辖市人民政府安全生产监督管理部门审批。
前款规定的行政主管部门应当自收到申请之日起30日内，对申请人提交的申请材料进行审查。对符合规定的，发给经营许可证，或者在企业已经取得的有关经营许可证件上标注；不予许可的，应当书面说明理由。
审查第一类易制毒化学品经营许可申请材料时，根据需要，可以进行实地核查。
第十一条 取得第一类易制毒化学品生产许可或者依照本条例第十三条第一款规定已经履行第二类、第三类易制毒化学品备案手续的生产企业，可以经销自产的易制毒化学品。但是，在厂外设立销售网点经销第一类易制毒化学品的，应当依照本条例的规定取得经营许可。第一类中的药品类易制毒化学品药品单方制剂，由麻醉药品定点经营企业经销，且不得零售。
第十二条 取得第一类易制毒化学品生产、经营许可的企业，应当凭生产、经营许可证到工商行政管理部门办理经营范围变更登记。未经变更登记，不得进行第一类易制毒化学品的生产、经营。第一类易制毒化学品生产、经营许可证被依法吊销的，行政主管部门应当自作出吊销决定之日起5日内通知工商行政管理部门；被吊销许可证的企业，应当及时到工商行政管理部门办理经营范围变更或者企业注销登记。
第十三条 生产第二类、第三类易制毒化学品的，应当自生产之日起30日内，将生产的品种、数量等情况，向所在地的设区的市级人民政府安全生产监督管理部门备案。
经营第二类易制毒化学品的，应当自经营之日起30日内，将经营的品种、数量、主要流向等情况，向所在地的设区的市级人民政府安全生产监督管理部门备案；经营第三类易制毒化学品的，应当自经营之日起30日内，将经营的品种、数量、主要流向等情况，向所在地的县级人民政府安全生产监督管理部门备案。前两款规定的行政主管部门应当于收到备案材料的当日发给备案证明。
第三章 购买管理
第十四条 申请购买第一类易制毒化学品，应当提交下列证件，经本条例第十五条规定的行政主管部门审批，取得购买许可证：
（一）经营企业提交企业营业执照和合法使用需要证明；
（二）其他组织提交登记证书（成立批准文件）和合法使用需要证明。
第十五条 申请购买第一类中的药品类易制毒化学品的，由所在地的省、自治区、直辖市人民政府食品药品监督管理部门审批；申请购买第一类中的非药品类易制毒化学品的，由所在地的省、自治区、直辖市人民政府公安机关审批。
前款规定的行政主管部门应当自收到申请之日起10日内，对申请人提交的申请材料和证件进行审查。对符合规定的，发给购买许可证；不予许可的，应当书面说明理由。
审查第一类易制毒化学品购买许可申请材料时，根据需要，可以进行实地核查。
第十六条 持有麻醉药品、第一类精神药品购买印鉴卡的医疗机构购买第一类中的药品类易制毒化学品的，无须申请第一类易制毒化学品购买许可证。
个人不得购买第一类、第二类易制毒化学品。
第十七条 购买第二类、第三类易制毒化学品的，应当在购买前将所需购买的品种、数量，向所在地的县级人民政府公安机关备案。个人自用购买少量高锰酸钾的，无须备案。
第十八条 经营单位销售第一类易制毒化学品时，应当查验购买许可证和经办人的身份证明。对委托代购的，还应当查验购买人持有的委托文书。
经营单位在查验无误、留存上述证明材料的复印件后，方可出售第一类易制毒化学品；发现可疑情况的，应当立即向当地公安机关报告。
第十九条 经营单位应当建立易制毒化学品销售台账，如实记录销售的品种、数量、日期、购买方等情况。销售台账和证明材料复印件应当保存2年备查。第一类易制毒化学品的销售情况，应当自销售之日起5日内报当地公安机关备案；第一类易制毒化学品的使用单位，应当建立使用台账，并保存2年备查。第二类、第三类易制毒化学品的销售情况，应当自销售之日起30日内报当地公安机关备案。
第四章 运输管理
第二十条 跨设区的市级行政区域（直辖市为跨市界）或者在国务院公安部门确定的禁毒形势严峻的重点地区跨县级行政区域运输第一类易制毒化学品的，由运出地的设区的市级人民政府公安机关审批；运输第二类易制毒化学品的，由运出地的县级人民政府公安机关审批。经审批取得易制毒化学品运输许可证后，方可运输。
运输第三类易制毒化学品的，应当在运输前向运出地的县级人民政府公安机关备案。公安机关应当于收到备案材料的当日发给备案证明。
第二十一条 申请易制毒化学品运输许可，应当提交易制毒化学品的购销合同，货主是企业的，应当提交营业执照；货主是其他组织的，应当提交登记证书（成立批准文件）；货主是个人的，应当提交其个人身份证明。经办人还应当提交本人的身份证明。
公安机关应当自收到第一类易制毒化学品运输许可申请之日起10日内，收到第二类易制毒化学品运输许可申请之日起3日内，对申请人提交的申请材料进行审查。对符合规定的，发给运输许可证；不予许可的，应当书面说明理由。审查第一类易制毒化学品运输许可申请材料时，根据需要，可以进行实地核查。
第二十二条 对许可运输第一类易制毒化学品的，发给一次有效的运输许可证。
对许可运输第二类易制毒化学品的，发给3个月有效的运输许可证；6个月内运输安全状况良好的，发给12个月有效的运输许可证。
易制毒化学品运输许可证应当载明拟运输的易制毒化学品的品种、数量、运入地、货主及收货人、承运人情况以及运输许可证种类。
第二十三条 运输供教学、科研使用的100克以下的麻黄素样品和供医疗机构制剂配方使用的小包装麻黄素以及医疗机构或者麻醉药品经营企业购买麻黄素片剂6万片以下、注射剂l.5万支以下，货主或者承运人持有依法取得的购买许可证明或者麻醉药品调拨单的，无须申请易制毒化学品运输许可。
第二十四条 接受货主委托运输的，承运人应当查验货主提供的运输许可证或者备案证明，并查验所运货物与运输许可证或者备案证明载明的易制毒化学品品种等情况是否相符；不相符的，不得承运。
运输易制毒化学品，运输人员应当自启运起全程携带运输许可证或者备案证明。公安机关应当在易制毒化学品的运输过程中进行检查。
运输易制毒化学品，应当遵守国家有关货物运输的规定。
第二十五条 因治疗疾病需要，患者、患者近亲属或者患者委托的人凭医疗机构出具的医疗诊断书和本人的身份证明，可以随身携带第一类中的药品类易制毒化学品药品制剂，但是不得超过医用单张处方的最大剂量。
医用单张处方最大剂量，由国务院卫生主管部门规定、公布。
第五章 进口、出口管理
第二十六条 申请进口或者出口易制毒化学品，应当提交下列材料，经国务院商务主管部门或者其委托的省、自治区、直辖市人民政府商务主管部门审批，取得进口或者出口许可证后，方可从事进口、出口活动：
（一）对外贸易经营者备案登记证明（外商投资企业联合年检合格证书）复印件；
（二）营业执照副本；
（三）易制毒化学品生产、经营、购买许可证或者备案证明；
（四）进口或者出口合同（协议）副本；
（五）经办人的身份证明。
申请易制毒化学品出口许可的，还应当提交进口方政府主管部门出具的合法使用易制毒化学品的证明或者进口方合法使用的保证文件。
第二十七条 受理易制毒化学品进口、出口申请的商务主管部门应当自收到申请材料之日起20日内，对申请材料进行审查，必要时可以进行实地核查。对符合规定的，发给进口或者出口许可证；不予许可的，应当书面说明理由。
对进口第一类中的药品类易制毒化学品的，有关的商务主管部门在作出许可决定前，应当征得国务院食品药品监督管理部门的同意。
第二十八条 麻黄素等属于重点监控物品范围的易制毒化学品，由国务院商务主管部门会同国务院有关部门核定的企业进口、出口。
第二十九条 国家对易制毒化学品的进口、出口实行国际核查制度。易制毒化学品国际核查目录及核查的具体办法，由国务院商务主管部门会同国务院公安部门规定、公布。
国际核查所用时间不计算在许可期限之内。
对向毒品制造、贩运情形严重的国家或者地区出口易制毒化学品以及本条例规定品种以外的化学品的，可以在国际核查措施以外实施其他管制措施，具体办法由国务院商务主管部门会同国务院公安部门、海关总署等有关部门规定、公布。
第三十条 进口、出口或者过境、转运、通运易制毒化学品的，应当如实向海关申报，并提交进口或者出口许可证。海关凭许可证办理通关手续。
易制毒化学品在境外与保税区、出口加工区等海关特殊监管区域、保税场所之间进出的，适用前款规定。
易制毒化学品在境内与保税区、出口加工区等海关特殊监管区域、保税场所之间进出的，或者在上述海关特殊监管区域、保税场所之间进出的，无须申请易制毒化学品进口或者出口许可证。
进口第一类中的药品类易制毒化学品，还应当提交食品药品监督管理部门出具的进口药品通关单。
第三十一条 进出境人员随身携带第一类中的药品类易制毒化学品药品制剂和高锰酸钾，应当以自用且数量合理为限，并接受海关监管。
进出境人员不得随身携带前款规定以外的易制毒化学品。
第六章 监督检查
第三十二条 县级以上人民政府公安机关、食品药品监督管理部门、安全生产监督管理部门、商务主管部门、卫生主管部门、价格主管部门、铁路主管部门、交通主管部门、工商行政管理部门、环境保护主管部门和海关，应当依照本条例和有关法律、行政法规的规定，在各自的职责范围内，加强对易制毒化学品生产、经营、购买、运输、价格以及进口、出口的监督检查；对非法生产、经营、购买、运输易制毒化学品，或者走私易制毒化学品的行为，依法予以查处。
前款规定的行政主管部门在进行易制毒化学品监督检查时，可以依法查看现场、查阅和复制有关资料、记录有关情况、扣押相关的证据材料和违法物品；必要时，可以临时查封有关场所。
被检查的单位或者个人应当如实提供有关情况和材料、物品，不得拒绝或者隐匿。
第三十三条 对依法收缴、查获的易制毒化学品，应当在省、自治区、直辖市或者设区的市级人民政府公安机关、海关或者环境保护主管部门的监督下，区别易制毒化学品的不同情况进行保管、回收，或者依照环境保护法律、行政法规的有关规定，由有资质的单位在环境保护主管部门的监督下销毁。其中，对收缴、查获的第一类中的药品类易制毒化学品，一律销毁。
易制毒化学品违法单位或者个人无力提供保管、回收或者销毁费用的，保管、回收或者销毁的费用在回收所得中开支，或者在有关行政主管部门的禁毒经费中列支。
第三十四条 易制毒化学品丢失、被盗、被抢的，发案单位应当立即向当地公安机关报告，并同时报告当地的县级人民政府食品药品监督管理部门、安全生产监督管理部门、商务主管部门或者卫生主管部门。接到报案的公安机关应当及时立案查处，并向上级公安机关报告；有关行政主管部门应当逐级上报并配合公安机关的查处。
第三十五条 有关行政主管部门应当将易制毒化学品许可以及依法吊销许可的情况通报有关公安机关和工商行政管理部门；工商行政管理部门应当将生产、经营易制毒化学品企业依法变更或者注销登记的情况通报有关公安机关和行政主管部门。
第三十六条 生产、经营、购买、运输或者进口、出口易制毒化学品的单位，应当于每年3月31日前向许可或者备案的行政主管部门和公安机关报告本单位上年度易制毒化学品的生产、经营、购买、运输或者进口、出口情况；有条件的生产、经营、购买、运输或者进口、出口单位，可以与有关行政主管部门建立计算机联网，及时通报有关经营情况。
第三十七条 县级以上人民政府有关行政主管部门应当加强协调合作，建立易制毒化学品管理情况、监督检查情况以及案件处理情况的通报、交流机制。
第七章 法律责任
第三十八条 违反本条例规定，未经许可或者备案擅自生产、经营、购买、运输易制毒化学品，伪造申请材料骗取易制毒化学品生产、经营、购买或者运输许可证，使用他人的或者伪造、变造、失效的许可证生产、经营、购买、运输易制毒化学品的，由公安机关没收非法生产、经营、购买或者运输的易制毒化学品、用于非法生产易制毒化学品的原料以及非法生产、经营、购买或者运输易制毒化学品的设备、工具，处非法生产、经营、购买或者运输的易制毒化学品货值10倍以上20倍以下的罚款，货值的20倍不足1万元的，按1万元罚款；有违法所得的，没收违法所得；有营业执照的，由工商行政管理部门吊销营业执照；构成犯罪的，依法追究刑事责任。
对有前款规定违法行为的单位或者个人，有关行政主管部门可以自作出行政处罚决定之日起3年内，停止受理其易制毒化学品生产、经营、购买、运输或者进口、出口许可申请。
第三十九条 违反本条例规定，走私易制毒化学品的，由海关没收走私的易制毒化学品；有违法所得的，没收违法所得，并依照海关法律、行政法规给予行政处罚；构成犯罪的，依法追究刑事责任。
第四十条 违反本条例规定，有下列行为之一的，由负有监督管理职责的行政主管部门给予警告，责令限期改正，处1万元以上5万元以下的罚款；对违反规定生产、经营、购买的易制毒化学品可以予以没收；逾期不改正的，责令限期停产停业整顿；逾期整顿不合格的，吊销相应的许可证：
（一）易制毒化学品生产、经营、购买、运输或者进口、出口单位未按规定建立安全管理制度的；
（二）将许可证或者备案证明转借他人使用的；
（三）超出许可的品种、数量生产、经营、购买易制毒化学品的；
（四）生产、经营、购买单位不记录或者不如实记录交易情况、不按规定保存交易记录或者不如实、不及时向公安机关和有关行政主管部门备案销售情况的；
（五）易制毒化学品丢失、被盗、被抢后未及时报告，造成严重后果的；
（六）除个人合法购买第一类中的药品类易制毒化学品药品制剂以及第三类易制毒化学品外，使用现金或者实物进行易制毒化学品交易的；
（七）易制毒化学品的产品包装和使用说明书不符合本条例规定要求的；
（八）生产、经营易制毒化学品的单位不如实或者不按时向有关行政主管部门和公安机关报告年度生产、经销和库存等情况的。
企业的易制毒化学品生产经营许可被依法吊销后，未及时到工商行政管理部门办理经营范围变更或者企业注销登记的，依照前款规定，对易制毒化学品予以没收，并处罚款。
第四十一条 运输的易制毒化学品与易制毒化学品运输许可证或者备案证明载明的品种、数量、运入地、货主及收货人、承运人等情况不符，运输许可证种类不当，或者运输人员未全程携带运输许可证或者备案证明的，由公安机关责令停运整改，处5000元以上5万元以下的罚款；有危险物品运输资质的，运输主管部门可以依法吊销其运输资质。
个人携带易制毒化学品不符合品种、数量规定的，没收易制毒化学品，处1000元以上5000元以下的罚款。
第四十二条 生产、经营、购买、运输或者进口、出口易制毒化学品的单位或者个人拒不接受有关行政主管部门监督检查的，由负有监督管理职责的行政主管部门责令改正，对直接负责的主管人员以及其他直接责任人员给予警告；情节严重的，对单位处1万元以上5万元以下的罚款，对直接负责的主管人员以及其他直接责任人员处1000元以上5000元以下的罚款；有违反治安管理行为的，依法给予治安管理处罚；构成犯罪的，依法追究刑事责任。
第四十三条 易制毒化学品行政主管部门工作人员在管理工作中有应当许可而不许可、不应当许可而滥许可，不依法受理备案，以及其他滥用职权、玩忽职守、徇私舞弊行为的，依法给予行政处分；构成犯罪的，依法追究刑事责任。
第八章 附 则
第四十四条 易制毒化学品生产、经营、购买、运输和进口、出口许可证，由国务院有关行政主管部门根据各自的职责规定式样并监制。
第四十五条 本条例自2005年11月1日起施行。
本条例施行前已经从事易制毒化学品生产、经营、购买、运输或者进口、出口业务的，应当自本条例施行之日起6个月内，依照本条例的规定重新申请许可。
附表：易制毒化学品的分类和品种目录
第一类
1．1－苯基－2－丙酮
2．3，4－亚甲基二氧苯基－2－丙酮
3．胡椒醛
4．黄樟素
5．黄樟油
6．异黄樟素
7. N－乙酰邻氨基苯酸
8．邻氨基苯甲酸
9．麦角酸＊
10．麦角胺＊
11．麦角新碱＊
12．麻黄素、伪麻黄素、消旋麻黄素、去甲麻黄素、甲基麻黄素、麻黄浸膏、麻黄浸膏粉等麻黄素类物质＊
第二类
1．苯乙酸
2．醋酸酐
3．三氯甲烷
4．乙醚
5．哌啶
第三类
1．甲苯
2．丙酮
3．甲基乙基酮
4．高锰酸钾
5．硫酸
6．盐酸
说明：
一、第一类、第二类所列物质可能存在的盐类，也纳入管制。
二、带有＊标记的品种为第一类中的药品类易制毒化学品，第一类中的药品类易制毒化学品包括原料药及其单方制剂。（完）
Regulations for Administration of Precursors and Chemicals used in Production of Narcotic Drugs and Psychotropic Substances
Order of the State Council
Order No. 445
The Regulations on the Administration of Precursor Chemicals, which were adopted at the 102nd executive meeting of the State Council on August 17th, 2005, are hereby promulgated and shall go into effect as of November 1st, 2005.
the Premier Wen Jiabao
August 26, 2005
Regulations on the Administration of Precursor Chemicals
Chapter I General Provisions
Article 1 For the purpose of strengthening the administration of precursor chemicals, regulating the production, distribution, purchase, transportation and import and export of precursor chemicals, preventing precursor chemicals from being used in manufacturing drugs and maintaining the economic and social order, the present Regulations are formulated.
Article 2 The state adopts the classified administration and licensing system to the production, distribution, purchase, transportation and import and export of precursor chemicals.
The precursor chemicals are classified into three categories. Category I includes the major materials that can be used for producing drugs. Categories II and III include the chemical agents that can be used for producing drugs. The detailed classification and types of precursor chemicals are shown in the annex of the present Regulation.
In case the classification or types of precursor chemicals need to be adjusted, the public security department of the State Council shall, in conjunction with the supervisory and administrative department of food and drugs, the supervisory and administrative department of safe production, the competent commerce department, the competent health department of the State Council and the General Administration of Customs, put forward a proposal and report it to the State Council for approval.
In case the people's government of the province, autonomous region or municipality directly under the Central Government deems it necessary to adjust the classification of precursor chemicals or to add any other type other than those as prescribed in the present Regulations within its administrative jurisdiction, it shall propose this to the public security department of the State Council. The public security department of the State Council shall put forward a proposal, and shall, in conjunction with the relevant competent administrative departments of the State Council, report it to the State Council for approval.
Article 3 The public security department, the supervisory and administrative department of food and drugs, the supervisory and administrative department of safe production, the competent commerce department, the competent health department, the General Administration of Customs, the competent pricing department, the competent railway department, the competent communications department, the administrative department for industry and commerce and the competent environmental protection department of the State Council shall, within the scope of their respective authority, be responsible for the relevant administration of precursor chemicals throughout the country. The relevant competent administrative departments of all the people's governments at or above the county level shall, within the scope of their respective authority, be responsible for the relevant administration of the precursor chemicals within their respective administrative jurisdictions.
All the people's governments at or above the county level shall strengthen their leadership in the administration of precursor chemicals, and coordinate to timely solve the problems arising from the administration of precursor chemicals.
Article 4 The product name （including the scientific name and the common name）, chemical molecular formula and ingredients of the chemical liable to producing drugs shall be clearly indicated on it packaging and instructions.
Article 5 The production, distribution, purchase, transportation and import and export of precursor chemicals shall comply with the relevant provisions of the present Regulations. And if the precursor chemicals belong to pharmaceuticals or dangerous chemicals, the relevant provisions of the laws and other administrative regulations on pharmaceuticals and dangerous chemicals shall be complied with as well.
It's prohibited to smuggle or illegally produce, operate, purchase, transfer or transport any chemical liable to producing drugs.
It's prohibited to trade precursor chemicals in cash or kind, however, an individual may legally purchases the pharmaceutical preparations of precursor chemicals under the item of pharmaceuticals in Category I or the precursor chemicals in Category III.
An entity that produces, distributes, purchases, transports, imports or exports the precursor chemicals shall establish an internal management system for precursor chemicals.
Article 6 The state encourages informants to inform the relevant competent administrative departments, such as the public security organs, of any illegal activities related to precursor chemicals. The department that receives a tip-off shall keep secret the relevant informant. If the tip-off turns out to be true, the people's government at or above the county level and the relevant competent administrative department shall award the relevant informant.
Chapter II Management of Production and Distribution
Article 7 An entity that applies for production of precursor chemicals in Category I, shall satisfy the following conditions and may start production only after it has obtained the production license upon the examination and approval of the competent administrative department as prescribed in Article 8 of the present Regulations :
（1） Having been legally registered as a production enterprise of chemical products or pharmaceuticals;
（2） Having the production equipments, warehouse facilities and pollutant disposal facilities that conform to the state standards;
（3） Having a strict safe production management system and a prepared plan for environmental emergencies;
（4） The legal representative and the technical and management personnel of the enterprise having the relevant knowledge of safe production and precursor chemicals, and having no record of drug-related crimes.
（5） Other conditions as prescribed by laws, regulations and rules.
An entity that applies for production of precursor chemicals under the item of pharmaceuticals in Category I shall not only satisfy the above-mentioned conditions, but also install, in key areas such as warehousing places, the video monitors and the alarm devices networked with the public security organ.
Article 8 An application for the production of precursor chemicals under the item of pharmaceuticals in Category I shall be subject to the examination and approval of the supervisory and administrative department of food and drugs of the State Council. An application for the production of precursor chemicals under any item in Category I other than pharmaceuticals shall be subject to the examination and approval of the supervisory and administrative department of safe production of the people's government of the province, autonomous region or municipality directly under the Central Government.
The competent administrative departments as prescribed in the preceding paragraph shall, within 60 days as of the day of receipt of an application, examine the application materials as submitted by the applicant. If the applicant satisfies the relevant provisions, it shall issue a production license to the applicant or give an indication on the relevant production license obtained by the relevant enterprise. In the case of disapproval, it shall notify, in writing, the applicant of the reasons therefore.
When examining the application materials for the production license of precursor chemicals in Category I, the competent administrative departments may, where necessary, organize an on-site inspection and expert review.
Article 9 An entity that applies for the distribution of precursor chemicals in Category I, shall satisfy the following conditions and may starts business operation only after it has obtained the distribution license upon the examination and approval of the competent administrative department as prescribed in Article 10 of the present Regulations:
（1） Having been legally registered as a distribution enterprise of chemical products or pharmaceuticals;
（2） Having a business place that conforms to the provisions of the state, and if the precursor chemicals need be stored or kept, having the warehouse facilities that conform to the technical standards of the state as well;
（3） Having an management system and a sound sales network for the distribution of precursor chemicals;
（4） The legal representative and the technical and management personnel of the enterprise having the relevant knowledge of precursor chemicals and having no record of drug-related crimes; and
（5） Other conditions as prescribed by laws, regulations and rules.
Article 10 An application for the distribution of the precursor chemicals under the item of pharmaceuticals in Category I shall be subject to the examination and approval of the supervisory and administrative department of food and drugs of the State Council. An application for the distribution of the precursor chemicals under any item in Category I other than pharmaceuticals shall be subject to the examination and approval of the supervisory and administrative department of safe production of the people's government of the province, autonomous region or municipality directly under the Central Government.
The competent administrative departments as prescribed in the preceding paragraph shall, within 30 days as of the day of receipt of an application, examine the application materials as submitted by the applicant. Where the applicant satisfies the relevant provisions, it shall issue a distribution license to the applicant or give an indication on the relevant business license that has been obtained by the relevant enterprise. In the case of disapproval, it shall notify, in writing, the applicant of the reasons therefore.
When conduct an examination on the application materials for distribution license for the precursor chemicals in Category I, the competent administrative departments may, where necessary, organize an on-site inspection.
Article 11 A production enterprise, which has obtained the production license for precursor chemicals in Category I or has gone through the record-keeping formalities for the production of precursor chemicals in Category II or III under the provisions of paragraph 1 of Article 13 of the present Regulations, may distribute the precursor chemicals it produces. However, where an enterprise is to establish sales outlets outside its factory for the distribution of precursor chemicals in Category I, it shall obtain the distribution license in accordance with the provisions of the present Regulations. The single preparations of precursor chemicals under the item of pharmaceuticals in Category I shall be distributed by the designated distribution enterprise of narcotic drugs and may not be retailed.
Article 12 An enterprise that has obtained the production or distribution license for precursor chemicals in Category I shall, upon the strength of its production or distribution license, register the alteration of its business scope with the administrative department for industry and commerce . No enterprise may produce or distribute the precursor chemicals in Category I unless the alteration of business scope has been registered. Where the production or distribution license for precursor chemicals in Category I is revoked pursuant to the law, the competent administrative department shall, within 5 days after making the decision on revocation, inform the administrative department for industry and commerce. The enterprise whose license has been revoked shall timely register the alteration of its business scope or nullify its registration with the administrative department for industry and commerce.
Article 13 An enterprise that produces the precursor chemicals in Category II or III shall, within 30 days as of the day of starting production, file such information as the type and quantity for record, with the supervisory and administrative department of safe production of the municipal people's government of the districted city where it is located.
An enterprise that distributes the precursor chemicals in Category II shall, within 30 days as of the day of starting distribution, file such information as the type, quantity and major flow direction for record, with the supervisory and administrative department of safe production of the municipal people's government of the districted city where it is located. An enterprise that distributes the precursor chemicals in Category III shall, within 30 days as of the day of starting distribution, file such information as the type, quantity and major flow direction for record, with the supervisory and administrative department of safe production of local people's government of the county where it is located. The competent administrative departments as prescribed in the preceding two paragraphs shall issue the record-keeping certification on the very day when it receives the materials submitted for record.
Chapter III Administration of Purchase
Article 14 An entity that applies for purchasing the precursor chemicals in Category I shall submit the following certificates to the competent administrative department as prescribed in Article 15 of the present Regulations for examination and approval, and obtain the purchase license therefrom upon approval:
（1） As for a distribution enterprise, the business license and the certification of its need for legal use and ;
（2） As for other organizations, the certificate of registration （approval document of establishment） and the certification of its need for legal use .
Article 15 With regard to the application for purchasing precursor chemicals under the item of pharmaceuticals in Category I, it shall be subject to the examination and approval of the supervisory and administrative department of food and drugs of the people's government of the province, autonomous region or municipality directly under the Central Government where the applicant is located. With regard to the application for purchasing precursor chemicals under any item in Category I other than pharmaceuticals, it shall be subject to the examination and approval of the public security organ of the people's government of the province, autonomous region or municipality directly under the Central Government where the applicant is located.
The competent administrative departments as prescribed in the preceding paragraph shall, within 10 days as of the day of receipt of an application, examine the application materials and certificates as submitted by the applicant. Where the applicant satisfies the relevant provisions, it shall issue a purchase license to the applicant; in the case of disapproval, it shall notify, in writing, the applicant of the reasons therefore.
When examining the application materials for purchasing precursor chemicals in Category I, the competent administrative departments may, where necessary, conduct an on-site inspection.
Article 16 Where a medical institution, which holds the seal card for purchasing narcotic and psychotropic pharmaceuticals in Category I, purchases the precursor chemicals under the item of pharmaceuticals in Category I, it need not apply for the purchase license for precursor chemicals in Category I.
No individual may purchase any chemical liable to producing drugs in Category I or II.
Article 17 An entity that is to purchase any chemical liable to producing drugs in Category II or III shall, prior to the purchase, file an information about the type and quantity in demand for record, with the public security organ of the local people's government at the county level. Any purchase of potassium permanganate of small quantity by an individual for self-use need not be put on record.
Article 18 A distribution entity, when selling the precursor chemicals in Category I, shall examine the purchase license and the proof of identity of the handling person. In the case of an entrusted purchase, it shall examine the power of attorney as held by the purchaser as well. A distribution entity may sell the precursor chemicals in Category I only if no error is found through the examination and after the photocopies of the above-mentioned materials are kept. Upon discovery of any suspicious circumstance, it shall immediately report it to the local public security organ.
Article 19 A distribution entity shall maintain a ledger for the sale of precursor chemicals and faithfully record the varieties, quantities, date and purchasers on the precursor chemicals sold. The sales ledger and photocopies of certification materials shall be preserved for 2 years for future reference and inspection. The sales information of precursor chemicals in Category I shall be submitted, within 5 days as of the day of sale, to the local public security organ for record. An entity that uses the precursor chemicals in Category I shall maintain a use ledger and preserve it for 2 years for future reference and inspection. The sales information of precursor chemicals in Category II or III shall be submitted, within 30 days as of the day of sale, to the local public security organ for record.
Chapter IV Administration of Transportation
Article 20 Where the transportation of precursor chemicals in Category I is across two or more the administrative areas at the level of districted cities （or across boundaries of a municipality in the case of municipalities directly under the Central Government） or across two or more administrative areas at the level of counties within the key areas where the anti-drug situation is severe, which are determined by the public security department of the State Council, it shall be subject to the examination and approval of the public security organ of the municipal people's government of the departure city which is divided into districts. The transportation of precursor chemicals in Category II shall be subject to the examination and approval of the public security organ of the people's government at the level of the departure county. No transportation may be conducted until the transportation license for precursor chemicals is granted upon examination.
The transportation of precursor chemicals in Category III shall, prior to departure, be flied for record with the local public security organ of the people's government at the level of county where the transportation starts; and the public security organ shall issue the record-keeping certification at the very day when it receives the materials submitted for record.
Article 21 As for an application for the transportation of precursor chemicals, the contract on purchase and sale of precursor chemicals shall be submitted. If the owner is an enterprise, its business license shall be submitted. If the owner is any other organization, the certificate of registration （approval document of establishment） shall be submitted. If the owner is an individual, his identity certificate shall be submitted. The individual who directly carries out the transportation shall submit his identity certificate.
The public security organ shall, within 10 days as of the day of receipt of the application for the transportation license for precursor chemicals in Category I, or within 3 days as of the day of receipt of the application for the transportation license for precursor chemicals in Category II, examine the application materials submitted by an applicant. If the applicant satisfies the relevant provisions, it shall issue the transportation license to the applicant. In the case of disapproval, it shall notify, in writing, the applicant of the reasons therefore. When necessary, an on-site examination may be conducted in examining the application materials for the transportation license for precursor chemicals in Category I .
Article 22 Where the transportation of precursor chemicals in Category I is approved, a transportation license valid for once shall be issued.
Where the transportation of precursor chemicals in Category II is approved, a transportation license valid for 3 months shall be issued; and where the transportation condition is safe and sound for 6 months, a transportation license valid for 12 months shall be issued.
Such matters as the type, quantity, destination, owner and consignee, and the carrier of the precursor chemicals to be transported as well as the type of the transportation license shall be clearly indicated in the transportation license for precursor chemicals.
Article 23 For the transportation of the ephedrine samples of less than 100g for the purpose of teaching or scientific research, or the small package ephedrine as used by medical institutions for the preparation and prescription, or the ephedrine of not more than 60, 000 pills or 15, 000 injection preparations as purchased by a medical institution or an narcotic drugs distributor, where the owner or carrier holds the purchase license or the allocating list of narcotic drugs as obtained according to law, it need not apply for the transportation license for precursor chemicals.
Article 24 When accepting the consignment from a owner, a carrier shall examine the transportation license or record-keeping certification provided by the owner, and verify whether or not the freight is consistent with the type of precursor chemicals and other information that are specified in the transportation license or the record-keeping certification. If it is found to be inconsistent, no goods may be transported.
In the transportation of precursor chemicals, the transportation personnel shall carry with them the transportation license or the record-keeping certification throughout the transportation period from the departure. The public security organ shall conduct inspections during the course of transportation of precursor chemicals.
The transportation of precursor chemicals shall comply with the provisions of the State on freight transportation.
Article 25 For the need of treatment of diseases, a patient, his near relative or the person as entrusted by the patient may, upon the strength of the medical diagnosis issued by a medical institution and his proof of identity, carry with him the medical preparation of precursor chemicals under the item of pharmaceuticals in Category I, provided it does not exceed the maximum dosage in a single medical prescription.
Chapter V Administration of Import and Export
Article 26 Anyone who applies for the import or export of precursor chemicals shall submit the following materials and may engage in the import or export of precursor chemicals only after it has obtained the import or export license upon the examination and approval of the competent commerce department of the State Council or the competent commerce department of the province, autonomous region or the municipality directly under the Central Government as authorized thereby:
（1） The photocopy of the registration certification of the foreign trade operator （the certification of annual joint examination for foreign-funded enterprises）;
（2） The duplicate of the business license;
（3） The licenses or the record-keeping certification for production, distribution, or purchase of precursor chemicals;
（4） The duplicate of the import or export contract （agreement）; and
（5） The identity certificate of the handling person.
Anyone who applies for the export license of precursor chemicals shall, in addition, submit the certification of legal use of precursor chemicals as issued by the competent governmental department of the region where the importer is located or the guaranty documents as provided by the importer on the legal use of precursor chemicals.
Article 27 The competent commerce department that accepts the application for the import and export of precursor chemicals shall, within 20 days as of the day of receipt of the application materials, examine the application materials and may, when necessary, conduct on-site inspection. If the applicant satisfies the relevant provisions, the competent commerce department shall issue the import or export license. If no license is granted, it shall notify, in writing, the applicant of the reasons therefore.
As for the import of precursor chemicals under the item of pharmaceuticals in Category I, the relevant competent commerce department shall obtain the consent of the supervisory and administrative department of food and drugs of the State Council before making any decision on licensing,.
Article 28 Ephedrine and other precursor chemicals falling within the scope of special control shall be imported or exported only by the enterprises as jointly verified by the competent commerce department of the State Council and the relevant departments of the State Council.
Article 29 The state adopts an international check-up system to the import and export of precursor chemicals. The catalogue of precursor chemicals subject to international check-up and the specific measures for check-up shall be formulated and promulgated by the competent commerce department of the State Council in conjunction with the public security department of the State Council.
The time used for the international examination may not be included into the time limit for licensing.
For the export of precursor chemicals and the chemicals other than those as provided by the present Regulations to a country or area where the illicit manufacture or trafficking of drugs is severe, other control measures may be taken in addition to the international check-up measures. The concrete measures shall be formulated and promulgated by the competent commerce department of the State Council in conjunction with the public security department of the State Council, the General Administration of Customs and other relevant departments.
Article 30 As for the import, export, transition, transshipment or through transportation of precursor chemicals, declaration shall be faithfully made to the customs and the import or export license shall be submitted thereto. The customs shall handle the clearance formalities according to the relevant license.
The provisions of the preceding paragraph shall be applicable to the import and export of precursor chemicals between overseas areas and the areas under special supervision of the customs or bonded areas, such as bonded zones and export processing zones.
As for the import and export of precursor chemicals between the areas within the territory of China and the areas under special supervision of the customs or bonded areas, such as bonded zones and export processing zones, or between the aforesaid areas under special supervision of the customs and bonded zones, it is not required to apply for the import or export license of precursor chemicals.
As for the import of precursor chemicals under the item of pharmaceuticals in Category I, the customs clearance notice of imported pharmaceuticals as issued by the supervisory and administrative department of food and drugs shall be submitted in addition.
Article 31 The pharmaceutical preparations of precursor chemicals under the item of pharmaceuticals in Category I or potassium permanganate carried by individuals entering and exiting the territory of China shall be limited to a reasonable amount for self-use and shall be subject to the supervision of the customs.
Any individual entering and exiting the territory of China may not carry with him any precursor chemicals other than those as set out in the preceding paragraph.
Chapter VI Supervision and Inspection
Article 32 The public security organs, the supervisory and administrative departments of food and drugs, the supervisory and administrative departments of safe production, the competent commerce departments, the competent health department, the competent pricing departments, the competent railway departments, the competent communications departments, the administrative departments for industry and commerce, the competent environmental protection departments of the people's government above the county level as well as the customs shall, in accordance with the present Regulations and the provisions of the relevant laws and administrative regulations, and within their respective authorities, strengthen the supervision and inspection of the manufacture, distribution, purchase, transportation, price and import and export of precursor chemicals, and shall, according to law, investigate into and deal with illegal manufacture, distribution, purchase and transportation of precursor chemicals or any smuggling of precursor chemicals.
When carrying out the supervision and inspection of precursor chemicals, the competent administrative departments as prescribed in the preceding paragraph may, according to law, inspect the scene, consult and copy the relevant materials, record the relevant information, detain the relevant evidence materials and illicit articles, and may seal up the relevant place temporarily when necessary.
Any entity or individual under inspection shall faithfully provide the relevant information, materials and articles and may not refuse to provide and conceal them.
Article 33 The precursor chemicals as captured and seized according to law shall be preserved and reclaimed in light of different conditions of the precursor chemicals under the supervision of the public security organ or the administrative environmental protection department of the people's government of the province, autonomous region, municipality directly under the Central Government or the districted city or under the supervision of the customs, or shall, in accordance with the relevant provisions of laws and administrative regulations on environmental protection, be destroyed by an qualified entity under the supervision of the administrative environmental protection department. In particular, the precursor chemicals under the item of pharmaceuticals in Category I as captured and seized shall be all destroyed.
Where an entity or individual that violates the relevant provisions on the precursor chemicals is unable to afford the expenses for the prevention, reclamation or destruction of the precursor chemicals concerned, such expenses shall be paid from the income as derived from the reclamation or shall be allotted in the anti-drug expenses of the relevant competent administrative department.
Article 34 Where precursor chemicals are lost, stolen or robbed, the entity concerned shall immediately report the case to the local public security organ and, at the same time, to the supervisory and administrative department of food and drugs, the supervisory and administrative department of safe production, the competent commerce department or the competent health department of the local people's government at the county level. The public security organ that receives the report shall immediately file the case and conduct investigations and shall report it to the public security organ at a higher level. The relevant competent administrative department shall report the case level by level and shall coordinate with the public security organ in the investigation.
Article 35 The relevant competent administrative department shall notify the relevant public security organ and the administrative department for industry and commerce of any issuance or revocation of the license of precursor chemicals according to law. The administrative department for industry and commerce shall notify the relevant public security organ and the competent administrative department of any alteration or cancellation of registration of the enterprises that engage in the production or distribution of precursor chemicals.
Article 36 An entity that produces, distributes, purchases, transports, imports or exports the precursor chemicals shall, prior to March 31st of each year, report the information about the production, distribution, purchase, transportation or import or export of precursor chemicals in the previous year, to the competent administrative department and the public security organ that grant the licensing or accept the materials submitted for record. An entity that produces, distributes, purchases, transports, imports or exports the precursor chemicals may, where the conditions permit, establish a computer network connected with the relevant competent administrative departments so as to timely report the relevant information on its business operation.
Article 37 The relevant competent administrative departments of the people's government at or above the county level shall intensify the coordination and cooperation and establish a mechanism for circulating and exchanging the information on the administration, supervision and inspection of precursor chemicals as well as on the handling of relevant cases .
Chapter VII Legal Liabilities
Article 38 Where an entity, in violation of the provisions of the present Regulations, engages in any production, distribution, purchase or transportation of precursor chemicals without license or filing relevant materials for record, forges application materials to cheat for the license of production, distribution, purchase or transportation, undertakes the production, distribution, purchase or transportation of precursor chemicals by using other's license or a forged, altered or invalid license, the public security organ shall confiscate the precursor chemicals illicitly produced, distributed, purchased or transported, the raw materials for illicit production of precursor chemicals and the equipments and tools for the illicit production, distribution, purchase or transportation of the precursor chemicals; and it shall impose a fine of not less than 10 times but not more than 20 times of the value of the precursor chemicals illicitly produced, distributed, purchased or transported. In case 20 times of such value is less than 10, 000 Yuan, the fine shall be 10, 000 Yuan. The relevant illicit gains, if any, shall be confiscated. If the violator has a business license, such business license shall be revoked by the administrative department for industry and commerce. If a crime is constituted, the relevant violator shall be investigated for criminal liabilities according to law.
As for an entity or individual that commits an irregular acts as prescribed in the preceding paragraph, the relevant competent administrative department may, within 3 years as of the day when administrative punishment is made, cease to accept its/his application for the license for production, distribution, purchase, transportation or import or export of precursor chemicals.
Article 39 Where an entity or individual, in violation of the provisions of the present Regulations, smuggles the precursor chemicals, the customs shall confiscate the precursor chemicals and the illicit gains, if any, and it shall impose an administrative sanction upon the violator in accordance with the customs laws and administrative regulations. If a crime is constituted, the relevant violator shall be investigated for criminal liabilities according to law.
Article 40 Where an entity, in violation of the provisions of the present Regulations, commits any of the following acts, the competent administrative department responsible for supervision and administration shall give it a warning and order it to make corrections within a prescribed time limit and impose a fine of not less than 10, 000 Yuan but not more than 50, 000 Yuan; and it may confiscate the precursor chemicals that are illicitly produced, distributed or purchased. If the violator fails to make corrections within the prescribed time limit, it shall be ordered to suspend its production and distribution for rectification within a prescribed time limit; and if the rectification is not made as required within the prescribed time limit, its relevant license shall be revoked:
（1） An entity that produces, distributes, purchases, transports or imports or exports the precursor chemicals fails to establish a safety management system as required;
（2） Lending its license or record-keeping certification to others;
（3） Producing, distributing or purchasing any precursor chemicals beyond the bound of licensed type and quantity;
（4） An entity that produces, distributes, purchases the precursor chemicals fails to record or to faithfully record the transaction information , or fails to keep the record of transaction as required or to timely and faithfully file the sales information for record with the public security organ and the relevant competent administrative departments;
（5） Failing to make a timely report when the precursor chemicals are lost, stolen or robbed, and thus causing serious consequences;
（6） Conducting transactions in cash or kind of any chemical liable to producing drugs other than those under the item of pharmaceuticals in Category I and those in Category III that may legally purchased by individuals;
（7） The product packaging or instructions of precursor chemicals does not comply with the provisions of the present Regulations; or
（8） An entity that produces, distributes, purchases the precursor chemicals fails to make annual report of its production, sales or inventory to the relevant competent administrative department and the public security organ faithful and timely.
Where an enterprise fails to timely alter its business scope or cancel its registration with the administrative department for industry and commerce after its business license for production and distribution of precursor chemicals is revoked pursuant to law, the precursor chemicals concerned shall be confiscated and a fine shall be imposed upon the enterprise according to the provisions of the preceding paragraph.
Article 41 Where the type, quantity, destination, owner, consignee or carrier of precursor chemicals in transportation is not in line with what is indicated in the transportation license or record-keeping certification for precursor chemicals, or where the type of the transportation license is improper or where the transportation personnel fail to carry with them the transportation license or record-keeping certification throughout the course of the transportation, the public security organ shall