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Regulation on the Administration of Precursor Chemicals [Revised]
易制毒化学品管理条例 [已被修订]
【法宝引证码】

 
Order of the State Council of the People's Republic of China 

中华人民共和国国务院令


(Order No. 445)
 
(第445号)


The Regulation on the Administration of Precursor Chemicals, which was adopted at the 102nd executive meeting of the State Council on August 17th, 2005, are hereby promulgated and shall come into force as of November 1st, 2005.
 
《易制毒化学品管理条例》已经2005年8月17日国务院第102次常务会议通过,现予公布,自2005年11月1日起施行。

Premier Wen Jiabao
 
总理 温家宝

August 26, 2005
 
二00五年八月二十六日

Regulation on the Administration of Precursor Chemicals
 

易制毒化学品管理条例


 
Chapter I General Provisions 

第一章 总则


 
Article 1 The present Regulation is formulated for the purpose of intensifying the administration of precursor chemicals, regulating the production, operation, purchase, transportation and import and export of precursor chemicals, preventing the use of precursor chemicals to manufacture drugs and maintaining the economic and social order.   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。

 
Article 2 The state adopts the classified administration and a licensing system for the production, operation, purchase, transportation and import and export of precursor chemicals.   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。

The precursor chemicals are classified into three categories. Category I refers to the major materials that may be used to produce drugs. Categories II and III refer to the chemical auxiliary substances that may be used to produce drugs. The specific classification and varieties of precursor chemicals are shown in the attachment of the present Regulation.
 
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。

Where the classification or variety of precursor chemicals requires any adjustment, the department of public security of the State Council shall, in collaboration with the supervisory and administrative department of food and drugs, the supervisory and administrative department of work safety, the administrative department of commerce, the administrative department of health and the General Administration of Customs of the State Council, report it to the State Council for approval.
 
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。

Where the people's government of the province, autonomous region or municipality directly under the Central Government believes it necessary to adjust the classification of precursor chemicals or to add any other variety beyond those as prescribed in the present Regulation within its administrative division, it shall set forth a suggestion to the department of public security of the State Council. The department of public security of the State Council shall, in collaboration with the relevant administrative departments of the State Council, raise a proposal and report it to the State Council for approval.
 
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。

 
Article 3 The department of public security, the supervisory and administrative department of food and drugs, the supervisory and administrative department of work safety, the administrative department of commerce, the administrative department of health, the General Administration of Customs, the administrative department of price, the administrative department of railways, the administrative department of communications, the administrative department for industry and commerce and the administrative department of environmental protection of the State Council shall, according to their respective functions and duties, take charge of the relevant administration of precursor chemicals throughout the country. The relevant administrative departments of all the people's governments at the county level or above shall, according to their respective functions and duties, take charge of the relevant administration of the precursor chemicals within their administrative divisions.   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。

All the people's governments at the county level or above shall intensify the leadership in the administration of precursor chemicals, and coordinate and solve any problem arising from the administration of precursor chemicals in a timely manner.
 
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。

 
Article 4 The product name (including the scientific name and the generally used name), chemical molecular formula and ingredients shall be indicated in the packaging and instructions of products of precursor chemicals.   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。

 
Article 5 For the production, operation, purchase, transportation and import and export of precursor chemicals, not only the relevant provisions of the present Regulation shall be observed, but also, where it belongs to pharmaceuticals or dangerous chemicals, the relevant provisions of the laws and other administrative regulations on pharmaceuticals and dangerous chemicals shall be abided by.   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。

It's prohibited to smuggle or illegally produce, operate, purchase, transfer or transport any precursor chemicals.
 
禁止走私或者非法生产、经营、购买、转让、运输易制毒化学品。

It's prohibited to trade in precursor chemicals by means of cash or in-kind, with the exception of any case whereby an individual legally purchases the pharmaceutical preparations of precursor chemicals under the item of pharmaceuticals in Category I or the precursor chemicals in Category III.
 
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。

An entity that engages in the production, operation, purchase and transportation and import and export of precursor chemicals shall establish an internal management system of precursor chemicals.
 
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。

 
Article 6 The state encourages the tip-off of any irregularity involving precursor chemicals to the relevant administrative departments such as the public security organ. The department that has received a tip-off shall keep confidential for the relevant tip-off maker. Where a tip-off has been verified, the people's government at the county level or above and the relevant administrative department shall grant an award to the relevant tip-off maker.   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。

 
Chapter II Management of Production and Operation 

第二章 生产、经营管理


 
Article 7 An entity, which applies for producing the precursor chemicals in Category I, shall meet the following requirements and shall obtain the production license upon the examination and approval of the administrative department as prescribed in Article 8 of the present Regulation before any production:   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:

 
(1)Having been legally registered as a production enterprise of chemical products or pharmaceuticals; (一)属依法登记的化工产品生产企业或者药品生产企业;

 
(2)Having the production equipment, warehousing facilities and waste disposal facilities that comply with the state standards; (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;

 
(3)Having a strict management system of work safety and the reserve plan for environmental emergencies; (三)有严格的安全生产管理制度和环境突发事件应急预案;

 
(4)The legal representative and the technical and management personnel of the enterprise having the relevant knowledge of work safety as well as of precursor chemicals and having no criminal record; and (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;

 
(5)Satisfying any other requirement as prescribed by any law, regulation or rule. (五)法律、法规、规章规定的其他条件。

An entity that applies for producing the precursor chemicals under the item of pharmaceuticals in Category I shall not only meet the aforesaid requirements but also establish television supervision and control facilities and the alarming facilities that are connected to the network of the public security organ in such key areas as warehousing places.
 
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。

 
Article 8 An application for producing 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 producing the precursor chemicals under any item other than pharmaceuticals in Category I 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.   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。

The administrative departments as prescribed in the preceding paragraph shall, within 60 days as of receiving an application, carry out an examination on the application materials as submitted by the applicant. For any application that meets the relevant provisions, it shall issue a production license or make an indication on the relevant production license that has been obtained by the relevant enterprise. In the case of disapproval, a written explanation shall be given.
 
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。

The administrative departments may, when carrying out an examination on the application materials for the production license of precursor chemicals in Category I, organize an on-the-spot inspection and expert appraisal when necessary.
 
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。

 
Article 9 An enterprise, which applies for operating the precursor chemicals in Category I, shall meet the following requirements and shall obtain the operation license upon the examination and approval of the administrative department as prescribed in Article 10 of the present Regulation before any operation:   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:

 
(1)Having legally been registered as an operation enterprise of chemical products or pharmaceuticals; (一)属依法登记的化工产品经营企业或者药品经营企业;

 
(2)Having a business place that meets the provisions of the state, and when it requires to store or keep any precursor chemicals, having the warehousing facilities that meet the technical standards of the state as well; (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;

 
(3)Having an operational and management system of precursor chemicals as well as complete sales network; (三)有易制毒化学品的经营管理制度和健全的销售网络;

 
(4)The legal representative and the technical and management personnel of the enterprise having the relevant knowledge of precursor chemicals and having no criminal record of drugs; and (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;

 
(5)Satisfying any other requirement as prescribed by any law, regulation or rule. (五)法律、法规、规章规定的其他条件。

 
Article 10 An application for operating 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 operating the precursor chemicals under any item other than pharmaceuticals in Category I 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.   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。

The administrative departments as prescribed in the preceding paragraph shall, within 30 days as of receiving an application, carry out an examination on the application materials as submitted by the applicant. For any application that meets the relevant provisions, it shall issue an operation license or make an indication on the relevant operation license that has been obtained by the relevant enterprise. In the case of disapproval, a written explanation shall be given.
 
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。

The administrative departments may, when carrying out an examination on the application materials for operation license of the precursor chemicals in Category I, organize an on-the-spot inspection when necessary.
 
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。

 
Article 11 A production enterprise that has obtained the production license of precursor chemicals in Category I or has gone through the archival formalities of the precursor chemicals in Category II or III according to the provisions of paragraph 1 of Article 13 of the present Regulation may undertake the sale of self-produced precursor chemicals. However, an enterprise that has a sales network of precursor chemicals in Category I outside its factory shall obtain the operation license according to the provisions of the present Regulation.   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。

The pharmaceutical single preparations of the precursor chemicals under the item of pharmaceuticals in Category I shall be distributed by the designated operation enterprise of narcotic drugs and shall not be retailed.
 
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。

 
Article 12 An enterprise that has obtained the production or operation license of the precursor chemicals in Category I shall go to the administrative department of industry and commerce to handle the formalities for the alteration of its business scope upon the strength of its production or operation license. Without the registration of alteration, no enterprise may carry out any production or operation of the precursor chemicals in Category I.   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。

Where any production or operation license of the precursor chemicals in Category I is revoked according to law, the administrative department shall inform the department of industry and commerce within 5 days as of making the decision on revocation. The enterprise whose license has been revoked shall go to the administrative department of industry and commerce to handle the formalities for altering its business scope or for enterprise termination registration in a timely manner.
 
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。

 
Article 13 An enterprise that produces the chemicals liable to producing chemicals in Category II or III shall, within 30 days as of production, report such information as variety and quantity to the supervisory and administrative department of work safety of the municipal people's government of the local districted city for archival filing.   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。

An enterprise that operates the chemicals liable to producing chemicals in Category II shall, within 30 days as of operation, report such information as variety, quantity and major flow to the supervisory and administrative department of work safety of the municipal people's government of the local districted city for archival filing. An enterprise that operates the chemicals liable to producing chemicals in Category III shall, within 30 days as of operation, report such information as variety, quantity and major flow to the supervisory and administrative department of work safety of the county local people's government of its locality for archival filing.
 
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。

The administrative departments as prescribed in the preceding two paragraphs shall issue the archival filing certification on the very day when it receives the archival filing materials.
 
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。

 
Chapter III Administration of Purchase 

第三章 购买管理


 
Article 14 An enterprise that applies for purchasing the precursor chemicals in Category I shall submit the following certificates and shall obtain the purchase license upon the examination and approval of the administrative department as prescribed in Article 15 of the present Regulation:   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:

 
(1)The business license and the certification of legal use and demand as submitted by the operation enterprise; (一)经营企业提交企业营业执照和合法使用需要证明;

 
(2)The registration certificate (approval certificate for establishment) and the certification of legal use and demand as submitted by any other organization. (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。

 
Article 15 An application for purchasing 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 people's government of the province, autonomous region or municipality directly under the Central Government where the applicant is located. An application for purchasing the precursor chemicals under any item other than pharmaceuticals in Category I shall be subject to the examination and approval of 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.   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。

The administrative departments as prescribed in the preceding paragraph shall, within 10 days as of receiving an application, carry out an examination on the application materials and certificates as submitted by an applicant. For an application that meets the relevant provisions, it shall issue a purchase certificate; in the case of disapproval, it shall give a written explanation.
 
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。

The administrative departments may, when carrying out an examination on the application materials for purchasing precursor chemicals in Category I, carry out an on-the-spot inspection when necessary.
 
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。

 
Article 16 Where a medical institution purchases the precursor chemicals under the item of pharmaceuticals in Category I upon the strength of the signature card for purchasing narcotic and psychotropic pharmaceuticals in Category I, it need not apply for the purchase license of precursor chemicals in Category I.
......
   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。
......

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