KYB CHINA(2005年8月26日中华人民共和国国务院令第445号公布 根据2014年7月29日《国务院关于修改部分行政法规的决定》第一次修订 根据2016年2月6日《国务院关于修改部分行政法规的决定》第二次修订 根据2018年9月18日《国务院关于修改部分行政法规的决定》第三次修订)
(Promulgated by Decree No. 445 of the State Council of the People's Republic of China on August 26, 2005; first revision according to the Decision of the State Council on Amending Certain Administrative Regulations on July 29, 2014; second revision according to the Decision of the State Council on Amending Certain Administrative Regulations on February 6, 2016; third revision according to the Decision of the State Council on Amending Certain Administrative Regulations on September 18, 2018)
总则
General Provisions
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。
This Regulation is formulated to strengthen the administration of precursor chemicals, regulate the production, operation, purchase, transport, import and export of precursor chemicals, prevent precursor chemicals from being used for drug manufacturing, and maintain economic and social order.
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 State implements classified administration and a licensing system for the production, operation, purchase, transport, import and export of precursor chemicals.
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。
Precursor chemicals are divided into three categories. Category I are main raw materials that can be used for drug manufacturing, and Categories II and III are chemical reagents that can be used for drug manufacturing. The specific classification and varieties of precursor chemicals are listed in the schedule attached to this Regulation.
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。
Adjustments to the classification and varieties of precursor chemicals shall be proposed by the public security department of the State Council jointly with the drug regulatory department, the work safety supervision department, the commerce department, the health department and the General Administration of Customs of the State Council, and submitted 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。
Where a people's government of a province, autonomous region, or municipality directly under the Central Government deems it necessary to adjust the classification or add varieties not specified in this Regulation within its administrative region, it shall submit a proposal to the public security department of the State Council, which shall, jointly with the relevant administrative departments of the State Council, propose a plan and submit it to the State Council for approval.
国务院公安部门、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、市场监督管理部门、生态环境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。
The public security department, drug regulatory department, work safety supervision department, commerce department, health department, General Administration of Customs, price department, railway department, transport department, market supervision department, and ecological environment department of the State Council shall, within their respective responsibilities, be responsible for the nationwide administration of precursor chemicals; the relevant administrative departments of local people's governments at or above the county level shall, within their respective responsibilities, be responsible for the administration of precursor chemicals within their administrative regions.
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。
Local people's governments at or above the county level shall strengthen leadership over the administration of precursor chemicals and promptly coordinate and resolve issues arising in the administration of precursor chemicals.
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。
The product packaging and instructions for use of precursor chemicals shall indicate the product name (including scientific name and common name), chemical molecular formula, and composition.
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。
The production, operation, purchase, transport, import, and export of precursor chemicals shall, in addition to complying with the provisions of these Regulations, also comply with the relevant provisions of laws and other administrative regulations on pharmaceuticals and hazardous chemicals if they fall under the category of pharmaceuticals or hazardous 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。
Smuggling or illegal production, operation, purchase, transfer, or transport of precursor chemicals is prohibited.
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。
Cash or in-kind transactions of precursor chemicals are prohibited, except for the lawful purchase by individuals of pharmaceutical preparations of Category I precursor chemicals that are pharmaceuticals and Category III 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。
Units that produce, operate, purchase, transport, import, or export precursor chemicals shall establish internal management systems for precursor chemicals.
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。
The State encourages reporting to the public security authorities and other relevant administrative departments of illegal acts involving precursor chemicals. The department receiving the report shall keep the reporter confidential. If the report is verified, the people's government at or above the county level and the relevant administrative departments shall give rewards.
生产、经营管理
Production and Operation Management
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：
An application for the production of Category I precursor chemicals shall meet the following conditions and shall be subject to the approval of the administrative department specified in Article 8 of these Regulations, and a production license shall be obtained before production may commence:
(一)属依法登记的化工产品生产企业或者药品生产企业；
(1) It is a legally registered chemical product production enterprise or pharmaceutical production enterprise;
(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；
(2) It has production equipment, storage facilities, and pollutant treatment facilities that meet national standards;
(三)有严格的安全生产管理制度和环境突发事件应急预案；
(3) It has a strict safety production management system and an environmental emergency response plan.
(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；
(4) The legal representative and technical and management personnel of the enterprise shall have knowledge of safety production and precursor chemicals, and have no drug crime record;
(五)法律、法规、规章规定的其他条件。
(5) Other conditions stipulated by laws, regulations, and rules.
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。
For an application to produce first-category pharmaceutical precursor chemicals, television surveillance facilities and alarm devices connected to the public security organs shall also be installed in key areas such as storage premises.
申请生产第一类中的药品类易制毒化学品的，由省、自治区、直辖市人民政府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。
An application to produce first-category pharmaceutical precursor chemicals shall be approved by the drug regulatory department of the people's government of the province, autonomous region, or municipality directly under the Central Government; an application to produce first-category non-pharmaceutical precursor chemicals shall be approved by the work safety regulatory department of the people's government of the province, autonomous region, or municipality directly under the Central Government.
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 department specified in the preceding paragraph shall, within 60 days from the date of receiving the application, review the application materials submitted by the applicant. If the requirements are met, a production license shall be issued, or the relevant production license already obtained by the enterprise shall be annotated; if the license is not granted, the reasons shall be stated in writing.
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。
When reviewing the application materials for a production license for first-category precursor chemicals, on-site inspection and expert evaluation may be conducted as necessary.
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：
To apply for operating first-category precursor chemicals, the following conditions shall be met, and the operation may only be carried out after obtaining an operation license approved by the administrative department specified in Article 10 of these Regulations:
(一)属依法登记的化工产品经营企业或者药品经营企业；
(1) It is a lawfully registered chemical product operating enterprise or pharmaceutical operating enterprise;
(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；
(2) It has business premises that meet national requirements; if storage and safekeeping of precursor chemicals are needed, it shall also have storage facilities that meet national technical standards;
(三)有易制毒化学品的经营管理制度和健全的销售网络；
(3) It has an operation management system for precursor chemicals and a sound sales network;
(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；
(4) The legal representative and sales and management personnel of the enterprise possess relevant knowledge of precursor chemicals and have no drug crime record;
(五)法律、法规、规章规定的其他条件。
(5) Other conditions prescribed by laws, regulations, and rules.
申请经营第一类中的药品类易制毒化学品的，由省、自治区、直辖市人民政府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。
An application for operating pharmaceutical precursor chemicals of the first category shall be approved by the drug regulatory department of the people's government of the province, autonomous region, or municipality directly under the Central Government; an application for operating non-pharmaceutical precursor chemicals of the first category shall be approved by the work safety regulatory department of the people's government of the province, autonomous region, or municipality directly under the Central Government.
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 department specified in the preceding paragraph shall, within 30 days from the date of receiving the application, review the application materials submitted by the applicant. If the application meets the requirements, it shall issue an operation license or mark the relevant operation license already obtained by the enterprise; if the license is not granted, reasons shall be provided in writing.
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。
When reviewing the application materials for the operation license of first-category precursor chemicals, on-site verification may be conducted as necessary.
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。
A production enterprise that has obtained a production license for first-category precursor chemicals or has fulfilled the record-filing procedures for second- and third-category precursor chemicals in accordance with paragraph 1 of Article 13 of these Regulations may sell the precursor chemicals it produces. However, if it establishes sales outlets outside the factory to sell first-category precursor chemicals, it shall obtain an operation license in accordance with these Regulations.
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。
Single-ingredient pharmaceutical preparations of pharmaceutical precursor chemicals of the first category shall be sold by enterprises designated for the operation of narcotic drugs and shall not be retailed.
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、经营许可证到市场监督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。
An enterprise that has obtained a production or operation license for first-category precursor chemicals shall, by virtue of the production or operation license, go through the change of business scope registration with the market supervision and management department. Without such change registration, it shall not engage in the production or operation of first-category precursor chemicals.
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日内通知市场监督管理部门；被吊销许可证的企业，应当及时到市场监督管理部门办理经营范围变更或者企业注销登记。
If a production or operation license for first-category precursor chemicals is lawfully revoked, the administrative department shall, within 5 days from the date of making the revocation decision, notify the market supervision and management department; the enterprise whose license has been revoked shall promptly go through the change of business scope or enterprise deregistration with the market supervision and management department.
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 produces second- or third-category precursor chemicals shall, within 30 days from the date of production, report the types and quantities of the chemicals produced to the work safety regulatory department of the city divided into districts where it is located for record 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。
Entities dealing in second-category precursor chemicals shall, within 30 days from the start of dealing, file records of the varieties, quantities, and main distribution channels with the municipal-level safety production supervision and management department of the local city divided into districts; entities dealing in third-category precursor chemicals shall, within 30 days from the start of dealing, file records of the varieties, quantities, and main distribution channels with the county-level safety production supervision and management department of the local county.
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。
The administrative departments specified in the preceding two paragraphs shall issue a filing certificate on the same day they receive the filing materials.
购买管理
Purchase Management
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：
To apply for the purchase of first-category precursor chemicals, the following documents shall be submitted, and after approval by the administrative department specified in Article 15 of these Regulations, a purchase license shall be obtained:
(一)经营企业提交企业营业执照和合法使用需要证明；
(1) For business enterprises, submit the business license and a certificate of legitimate use need;
(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。
(2) For other organizations, submit the registration certificate (establishment approval document) and a certificate of legitimate use need.
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。
Applications for purchasing pharmaceutical first-category precursor chemicals shall be approved by the provincial-level drug regulatory department of the province, autonomous region, or municipality directly under the Central Government; applications for purchasing non-pharmaceutical first-category precursor chemicals shall be approved by the provincial-level public security department of the province, autonomous region, or municipality directly under the Central Government.
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 department specified in the preceding paragraph shall, within 10 days from receipt of the application, review the application materials and documents submitted by the applicant. If the requirements are met, a purchase license shall be issued; if not, the reasons shall be provided in writing.
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。
When reviewing application materials for a first-category precursor chemical purchase license, on-site verification may be conducted as necessary.
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。
Medical institutions holding a purchase seal card for narcotic drugs and first-category psychotropic substances purchasing pharmaceutical first-category precursor chemicals are not required to apply for a first-category precursor chemical purchase license.
个人不得购买第一类、第二类易制毒化学品。
Individuals shall not purchase Category 1 or Category 2 precursor chemicals.
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。
When purchasing Category 2 or Category 3 precursor chemicals, the purchaser shall, prior to the purchase, report the type and quantity of the chemicals to be purchased to the local public security authority of the county-level people's government. Individuals purchasing small quantities of potassium permanganate for personal use are exempt from reporting.
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。
When selling Category 1 precursor chemicals, business units shall verify the purchase permit and the identity certificate of the person handling the transaction. For purchases made through an agent, the business unit shall also verify the power of attorney held by the purchaser.
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。
Only after verification and retention of copies of the above-mentioned certification materials may business units sell Category 1 precursor chemicals; if any suspicious circumstances are discovered, they shall immediately report to the local public security authority.
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。
Business units shall establish sales ledgers for precursor chemicals, truthfully recording the type, quantity, date, and purchaser of the chemicals sold. Copies of sales ledgers and certification materials shall be kept for two years for future reference.
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。
Sales of Category 1 precursor chemicals shall be reported to the local public security authority for the record within five days from the date of sale; entities using Category 1 precursor chemicals shall establish usage ledgers and keep them for two years for future reference.
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。
Sales of Category 2 and Category 3 precursor chemicals shall be reported to the local public security authority for the record within thirty days from the date of sale.
运输管理
Transport Management
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。
For the transport of Category 1 precursor chemicals across city-level administrative regions (across city boundaries in municipalities directly under the central government) or across county-level administrative regions in key areas with severe drug control situations determined by the public security department of the State Council, approval shall be obtained from the public security authority of the city-level people's government at the place of departure; for the transport of Category 2 precursor chemicals, approval shall be obtained from the public security authority of the county-level people's government at the place of departure. Transport may only be carried out after obtaining a precursor chemical transport permit upon approval.
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。
For the transport of Category 3 precursor chemicals, the transporter shall report to the public security authority of the county-level people's government at the place of departure prior to transport. The public security authority shall issue a record certificate on the same day of receiving the reporting materials.
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。
To apply for a transport permit for precursor chemicals, the applicant shall submit the purchase and sale contract for the precursor chemicals. If the cargo owner is an enterprise, the business license shall be submitted; if the cargo owner is another organization, the registration certificate (or establishment approval document) shall be submitted; if the cargo owner is an individual, the individual's identity document shall be submitted. The handler shall also submit his/her own identity document.
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。
The public security organ shall, within 10 days from receipt of the application for a transport permit for Category I precursor chemicals, and within 3 days from receipt of the application for a transport permit for Category II precursor chemicals, review the application materials submitted by the applicant. If the application meets the requirements, a transport permit shall be issued; if the permit is not granted, the reasons shall be provided in writing.
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。
When reviewing the application materials for a transport permit for Category I precursor chemicals, an on-site inspection may be conducted as necessary.
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。
For a transport permit for Category I precursor chemicals, a single-use transport permit shall be issued.
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。
For a transport permit for Category II precursor chemicals, a transport permit valid for 3 months shall be issued; if the transport safety condition is good within 6 months, a transport permit valid for 12 months shall be issued.
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。
The transport permit for precursor chemicals shall specify the types and quantities of precursor chemicals to be transported, the destination, the cargo owner and consignee, the carrier, and the type of transport permit.
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1.5万支以下，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。
For the transport of ephedrine samples of less than 100 grams for teaching and scientific research, small-packaged ephedrine for the formulation of medical institution preparations, or ephedrine tablets of no more than 60,000 tablets or injections of no more than 15,000 ampoules purchased by medical institutions or narcotic drug business enterprises, if the cargo owner or carrier holds a lawfully obtained purchase permit or narcotic drug allocation order, no transport permit for precursor chemicals is required.
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。
When accepting a consignment from the cargo owner, the carrier shall verify the transport permit or filing certificate provided by the cargo owner, and check whether the goods to be transported are consistent with the types of precursor chemicals specified in the transport permit or filing certificate; if inconsistent, the carrier shall not transport them.
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。
When transporting precursor chemicals, the transport personnel shall carry the transport permit or filing certificate throughout the journey from departure. The public security organ may conduct inspections during the transport of precursor chemicals.
运输易制毒化学品，应当遵守国家有关货物运输的规定。
The transport of precursor chemicals shall comply with the relevant state regulations on the transport of goods.
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。
For the purpose of treating diseases, patients, their close relatives, or persons authorized by the patient may carry with them pharmaceutical preparations of Category I precursor chemicals in the form of pharmaceutical products, based on a medical diagnosis certificate issued by a medical institution and their own identity documents, provided that the quantity does not exceed the maximum dosage of a single medical prescription.
医用单张处方最大剂量，由国务院卫生主管部门规定、公布。
The maximum dosage of a single medical prescription shall be prescribed and published by the competent health department of the State Council.
进口、出口管理
Import and Export Management
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：
To apply for the import or export of precursor chemicals, the following materials shall be submitted, and after approval by the competent commerce department of the State Council or its entrusted provincial-level commerce department, and upon obtaining an import or export license, the import or export activities may be conducted:
(一)对外贸易经营者备案登记证明复印件；
(1) A copy of the registration certificate for foreign trade operators;
(二)营业执照副本；
(2) A copy of the business license;
(三)易制毒化学品生产、经营、购买许可证或者备案证明；
(3) The production, operation, or purchase permit or registration certificate for precursor chemicals;
(四)进口或者出口合同(协议)副本；
(4) A copy of the import or export contract (agreement);
(五)经办人的身份证明。
(5) Identity documents of the handling person.
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。
For applications for export permits for precursor chemicals, a certificate of lawful use of precursor chemicals issued by the competent government authority of the importing party or a guarantee document for lawful use by the importing party shall also be submitted.
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。
The competent commerce department that accepts an application for import or export of precursor chemicals shall, within 20 days from the date of receiving the application materials, review the application materials and may conduct an on-site inspection if necessary. If the application meets the requirements, it shall issue an import or export license; if the license is not granted, the reasons shall be stated in writing.
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，应当征得国务院药品监督管理部门的同意。
For the import of Category 1 pharmaceutical precursor chemicals, the relevant commerce department shall obtain the consent of the drug regulatory department of the State Council before making a licensing decision.
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。
Ephedrine and other precursor chemicals that fall within the scope of key monitored items shall be imported or exported by enterprises designated by the competent commerce department of the State Council in conjunction with the relevant departments of the State Council.
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。
The state implements an international verification system for the import and export of precursor chemicals. The catalogue of precursor chemicals subject to international verification and the specific verification measures shall be formulated and published by the competent commerce department of the State Council in conjunction with the public security department of the State Council.
国际核查所用时间不计算在许可期限之内。
The time taken for international verification shall not be counted within the licensing period.
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。
For the export of precursor chemicals and chemicals other than those specified in these regulations to countries or regions with serious drug manufacturing or trafficking situations, other control measures may be implemented in addition to international verification measures. The specific measures shall be formulated and published 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.
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。
When importing, exporting, transiting, transshipping, or transporting precursor chemicals through China, the party shall truthfully declare to the customs and submit the import or export license. The customs shall handle the customs clearance procedures based on the license.
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。
The preceding paragraph applies to the entry and exit of precursor chemicals between foreign territories and special customs supervision areas such as bonded zones and export processing zones, as well as bonded places.
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。
For the entry and exit of precursor chemicals between domestic territories and special customs supervision areas such as bonded zones and export processing zones, or between such special customs supervision areas and bonded places, no import or export license for precursor chemicals is required.
进口第一类中的药品类易制毒化学品，还应当提交药品监督管理部门出具的进口药品通关单。
For the import of Category 1 pharmaceutical precursor chemicals, a customs clearance form for imported pharmaceuticals issued by the drug regulatory department shall also be submitted.
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。
Persons entering or leaving the country may carry pharmaceutical precursor chemicals of Category I and potassium permanganate only for personal use and in reasonable quantities, and shall be subject to customs supervision.
进出境人员不得随身携带前款规定以外的易制毒化学品。
Persons entering or leaving the country shall not carry precursor chemicals other than those specified in the preceding paragraph.
监督检查
Supervision and Inspection
县级以上人民政府公安机关、负责药品监督管理的部门、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、市场监督管理部门、生态环境主管部门和海关，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。
The public security organs, drug regulatory departments, work safety supervision departments, commerce departments, health departments, price departments, railway departments, transportation departments, market supervision departments, ecological environment departments, and customs of the people's governments at or above the county level shall, in accordance with this Regulation and relevant laws and administrative regulations, strengthen the supervision and inspection of the production, operation, purchase, transport, price, import, and export of precursor chemicals within their respective responsibilities; and shall investigate and deal with illegal production, operation, purchase, transport of precursor chemicals or smuggling of precursor chemicals according to law.
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。
The administrative departments specified in the preceding paragraph may, when conducting supervision and inspection of precursor chemicals, inspect the site, consult and copy relevant materials, record relevant information, and seize relevant evidence materials and illegal items according to law; when necessary, they may temporarily seal up relevant premises.
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。
The unit or individual being inspected shall truthfully provide relevant information, materials, and items, and shall not refuse or conceal them.
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、海关或者生态环境主管部门的监督下，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，由有资质的单位在生态环境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。
Precursor chemicals that are lawfully confiscated or seized shall be stored, recycled, or destroyed by qualified units under the supervision of the public security organs, customs, or ecological environment departments of the people's governments of provinces, autonomous regions, municipalities directly under the Central Government, or cities divided into districts, depending on the different circumstances of the precursor chemicals, and in accordance with the relevant provisions of environmental protection laws and administrative regulations. Among them, confiscated or seized pharmaceutical precursor chemicals of Category I shall be destroyed in all cases.
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。
If the unit or individual that illegally dealt with precursor chemicals is unable to bear the costs of storage, recycling, or destruction, such costs shall be covered by the proceeds from recycling or shall be listed in the anti-drug funds of the relevant administrative departments.
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负责药品监督管理的部门、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。
If precursor chemicals are lost, stolen, or robbed, the unit where the incident occurred shall immediately report to the local public security organ, and at the same time report to the local county-level people's government's drug regulatory department, work safety supervision department, commerce department, or health department. The public security organ that receives the report shall promptly file a case for investigation and report to the higher-level public security organ; the relevant administrative departments shall report level by level and cooperate with the public security organ's investigation.
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市场监督管理部门；市场监督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。
The relevant administrative departments shall notify the relevant public security organs and market supervision departments of the granting of precursor chemical permits and the revocation of permits according to law; the market supervision departments shall notify the relevant public security organs and administrative departments of the changes or cancellations of registration of enterprises that produce or operate precursor chemicals according to law.
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。
Units that produce, operate, purchase, transport, or import/export precursor chemicals shall, before March 31 each year, report to the administrative department that granted the permit or filed the record and to the public security organ on the production, operation, purchase, transport, or import/export of precursor chemicals in the previous year; units with the capability may establish computer networking with relevant administrative departments to promptly report relevant operational information.
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。
The relevant administrative departments of the people's governments at or above the county level shall strengthen coordination and cooperation, and establish a mechanism for the notification and exchange of information on the management, supervision, inspection, and case handling of precursor chemicals.
法律责任
Legal Liability
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，由市场监督管理部门吊销营业执照；构成犯罪的，依法追究刑事责任。
Whoever, in violation of these Regulations, produces, operates, purchases, or transports precursor chemicals without a permit or record, obtains a permit for production, operation, purchase, or transport of precursor chemicals by forging application materials, or uses another person's or a forged, altered, or invalid permit to produce, operate, purchase, or transport precursor chemicals, shall be subject to confiscation by the public security organ of the illegally produced, operated, purchased, or transported precursor chemicals, raw materials used for illegal production of precursor chemicals, and equipment and tools used for illegal production, operation, purchase, or transport of precursor chemicals; a fine of not less than 10 times but not more than 20 times the value of the illegally produced, operated, purchased, or transported precursor chemicals shall be imposed; if 20 times the value is less than 10,000 yuan, the fine shall be 10,000 yuan; any illegal income shall be confiscated; if the violator has a business license, the market supervision and administration department shall revoke the business license; if a crime is constituted, criminal liability shall be pursued according to law.
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。
For a unit or individual that has committed the illegal act specified in the preceding paragraph, the relevant administrative department may, within three years from the date of the administrative penalty decision, stop accepting its application for a permit for production, operation, purchase, transport, or import/export of precursor chemicals.
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。
Whoever, in violation of these Regulations, smuggles precursor chemicals shall be subject to confiscation by the customs of the smuggled precursor chemicals; any illegal income shall be confiscated, and an administrative penalty shall be imposed in accordance with customs laws and administrative regulations; if a crime is constituted, criminal liability shall be pursued according to law.
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：
Whoever, in violation of these Regulations, commits any of the following acts shall be given a warning by the administrative department with supervisory responsibility, ordered to correct within a time limit, and fined not less than 10,000 yuan but not more than 50,000 yuan; the precursor chemicals produced, operated, or purchased in violation of regulations may be confiscated; if correction is not made within the time limit, the violator shall be ordered to suspend production or business for rectification; if rectification is still unqualified after the suspension, the corresponding permit shall be revoked:
(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；
(1) A unit that produces, operates, purchases, transports, or imports/exports precursor chemicals fails to establish a safety management system as required;
(二)将许可证或者备案证明转借他人使用的；
(2) Lending the permit or record certificate to others for use;
(三)超出许可的品种、数量生产、经营、购买易制毒化学品的；
(3) Producing, operating, or purchasing precursor chemicals beyond the permitted varieties or quantities;
(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；
(4) Where a production, operation, or purchase unit fails to record or truthfully record transaction details, fails to preserve transaction records as required, or fails to truthfully and timely report sales to the public security organ and relevant administrative departments;
(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；
(5) Where a precursor chemical is lost, stolen, or robbed and the incident is not reported in a timely manner, causing serious consequences;
(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；
(6) Where, except for the lawful purchase by individuals of pharmaceutical precursor chemical preparations in Category I and precursor chemicals in Category III, cash or in-kind transactions are used for precursor chemical transactions;
(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；
(7) Where the product packaging and instructions for use of precursor chemicals do not meet the requirements of these Regulations;
(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。
(8) Where a unit producing or operating precursor chemicals fails to truthfully or timely report to the relevant administrative department and public security organ the annual production, distribution, and inventory.
企业的易制毒化学品生产经营许可被依法吊销后，未及时到市场监督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。
If, after the enterprise's precursor chemical production and operation permit is lawfully revoked, it fails to timely apply to the market supervision and administration department for change of business scope or enterprise cancellation registration, the precursor chemicals shall be confiscated and a fine imposed in accordance with the preceding paragraph.
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。
Where the transported precursor chemicals do not match the variety, quantity, destination, consignor, consignee, or carrier specified in the precursor chemical transport permit or filing certificate, the type of transport permit is improper, or the transport personnel do not carry the transport permit or filing certificate throughout the journey, the public security organ shall order a halt for rectification and impose a fine of not less than 5,000 yuan but not more than 50,000 yuan; if the unit has a dangerous goods transport qualification, the transport authority may lawfully revoke its transport qualification.
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。
Where an individual carries precursor chemicals that do not comply with the specified variety or quantity, the precursor chemicals shall be confiscated, and a fine of not less than 1,000 yuan but not more than 5,000 yuan shall be imposed.
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。
Where a unit or individual producing, operating, purchasing, transporting, importing, or exporting precursor chemicals refuses to accept supervision and inspection by the relevant administrative department, the administrative department responsible for supervision shall order correction, and issue a warning to the directly responsible person in charge and other directly responsible persons; if the circumstances are serious, a fine of not less than 10,000 yuan but not more than 50,000 yuan shall be imposed on the unit, and a fine of not less than 1,000 yuan but not more than 5,000 yuan shall be imposed on the directly responsible person in charge and other directly responsible persons; if the act violates public security administration, public security administration penalties shall be imposed according to law; if a crime is constituted, criminal liability shall be pursued according to law.
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。
Where staff members of the administrative department for precursor chemicals, in the course of management, fail to grant a license when they should, grant a license when they should not, fail to accept filings according to law, or engage in other acts of abuse of power, dereliction of duty, or favoritism, administrative sanctions shall be imposed according to law; if a crime is constituted, criminal liability shall be pursued according to law.
附则
Supplementary Provisions
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。
The licenses for the production, operation, purchase, transport, import, and export of precursor chemicals shall have their formats designed and be supervised by the relevant administrative departments of the State Council according to their respective responsibilities.
本条例自2005年11月1日起施行。
These Regulations shall come into force as of November 1, 2005.
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。
Entities that were already engaged in the production, operation, purchase, transport, import, or export of precursor chemicals before the implementation of these Regulations shall, within six months from the date of implementation, re-apply for licenses in accordance with the provisions of these Regulations.
附表
Appendix
易制毒化学品的分类和品种目录
Classification and Catalog of Precursor Chemicals
第一类
Category I
1．1—苯基—2—丙酮
1. 1-Phenyl-2-propanone
2．3，4—亚甲基二氧苯基—2—丙酮
2. 3,4-Methylenedioxyphenyl-2-propanone
3．胡椒醛
3. Piperonal
4．黄樟素
4. Sassafras aldehyde
5．黄樟油
5. Sassafras oil
6．异黄樟素
6. Isosafrole
7．N—乙酰邻氨基苯酸
7. N-Acetylanthranilic acid
8．邻氨基苯甲酸
8. Anthranilic acid
9．麦角酸*
9. Lysergic acid*
10．麦角胺*
10. Ergotamine*
11．麦角新碱*
11. Ergometrine*
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*
12. Ephedrine, pseudoephedrine, racemic ephedrine, norephedrine, methylephedrine, ephedra extract, ephedra extract powder, and other ephedrine-like substances*
第二类
Second Category
1．苯乙酸
1. Phenylacetic acid
2．醋酸酐
2. Acetic anhydride
3．三氯甲烷
3. Chloroform
4．乙醚
4. Diethyl ether
5．哌啶
5. Piperidine
第三类
Third Category
1．甲苯
1. Toluene
2．丙酮
2. Acetone
3．甲基乙基酮
3. Methyl Ethyl Ketone
4．高锰酸钾
4. Potassium Permanganate
5．硫酸
5. Sulfuric acid
6．盐酸
6. Hydrochloric acid
说明：
Explanation:
一、第一类、第二类所列物质可能存在的盐类，也纳入管制。
I. Salts that may exist of the substances listed in Class I and Class II are also subject to control.
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。
II. Items marked with an asterisk (*) are pharmaceutical precursor chemicals in Class I. Pharmaceutical precursor chemicals in Class I include active pharmaceutical ingredients and their single-ingredient preparations.