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国务院关于进一步加强麻黄素管理的通知(中英对照)

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Circular of the State Council Concerning Further Strengthening Ephedrine Control

 

我国是天然麻黄素的主要生产国和出口国之一。
China is one of the major producing and exporting countries of natural ephedrine.

麻黄素既是制药原料,又是制造甲基苯丙胺(“冰”毒)的前体。
Ephedrine is both the raw material for medicine and the precursor for making methamphetamine ("ice" drug).

近年来,国际贩毒集团与国内贩毒分子相互勾结,将麻黄素大量走私贩运出境,或以投资办厂、合资制药、生产民用化学品等为名,在国内非法加工制造“冰”毒,将其成品或半成品走私出境。
In recent years, international drug trafficking groups have, in collusion with drug traffickers at home, smuggled large quantities of ephedrine out of the country, or engaged in illegal processing and manufacturing of methamphetamine at home in the name of establishing plants with investment, joint ventures for making medicine and production of chemicals for civilian applications and smuggled their products or semi-products out of the country.

少数地方和部门为了追求经济利益,违反国家有关规定,大量生产、经营麻黄素,给不法分子制做“冰”毒以可乘之机。
A small number of localities and departments provided lawless persons with an opportunity to manufacture methamphetamine in the production and management of ephedrine in large quantities in pursuit of economic benefits in violation of the relevant state provisions.

这种情况已引起国际社会特别是国际禁毒组织的关注,有损我国的国际形象。
This state of affairs has aroused the concern of the international community especially that of the International Anti-drug Organization and has been detrimental to the international image of China.

为进一步加强麻黄素的管理工作,防止麻黄素流入非法渠道,保障人民身体健康,现就有关问题通知如下:
The relevant questions are hereby notified as follows with a view to further strengthening ephedrine control, preventing ephedrine from getting into illegal channels and ensuring people’s health:

一、各级人民政府和有关部门要提高认识,切实加强对麻黄素管理工作的领导,严格执行国家法律、法规,落实麻黄素管理责任制。
I. People’s governments at all levels and the departments concerned should enhance their understanding, earnestly strengthen the leadership of ephedrine control, strictly abide by state laws and regulations and practice the ephedrine control responsibility system.

要采取有力措施,对现有生产、经营麻黄素的企业进行清理整顿;
Strong measures should be taken for the sorting out and consolidation of enterprises producing and managing ephedrine;

对非法生产、经营麻黄素的企业或单位,坚决依法取缔;
enterprises or units engaging in illegal production and management of ephedrine should be firmly banned according to law;

对因管理不善使麻黄素流入非法渠道的生产、经营企业坚决取消其生产、经营资格并依法追究有关部门和单位直接责任人员的法律责任。
with respect to those production and management enterprises that caused ephedrine to get into illegal channels due to mismanagement should be firmly nullified of their production and management qualifications and personnel directly responsible of the departments and units concerned shall be investigated of the legal liability according to law.

二、国家对麻黄素(含从麻黄草提取和化学合成的,包括左、右旋)及其盐类如盐酸麻黄 素、草酸麻黄素、硫酸麻黄素和麻黄素粗品(含麻黄浸膏、麻黄浸膏粉、麻黄草粉)、麻黄素衍生物以及以麻黄素为原料生产的单方制剂等的生产、经营、使用、出口实行专项管理制度 。
II. The State practices the special-purpose control system with respect to the production, management, use and export of ephedrine (including extracts from ephedra grass and chemically synthesized, laevorotatory and dextrotatory) as well as their saline categories such as ephedrine hydrochloride, ephedrine oxalic, ephedrine sulphate and raw products of ephedrine (including ephedrine extracts, ephedrine extract powder and ephedra powder), ephedrine derivatives and prescribed preparations made with ephedrine as the raw material.

(一)对麻黄素实行定点、定量、计划生产。
(1) Planned production of ephedrine shall be carried out at designated points in fixed quantity.

麻黄素定点生产企业由国家药品管理部门指定,报全国禁毒工作领导小组办公室备案。
The designated enterprises for the production of ephedrine shall be appointed by the state department of pharmaceutical administration and submitted to the Office of the National Anti-drug Leading Group for the record.

未经指定的任何单位和个人,不得从事麻黄素的生产活动。
No unit or individual without appointment shall engage in production activities of ephedrine.

麻黄素的年度生产计划由国家药品管理部门审定。
The annual production plan of ephedrine shall be examined and finalized by the state department of pharmaceutical administration.

麻黄素定点生产企业制订下一年度的生产计划(包括供应出口计划),经所在省、自治区、直辖市药品管理部门初审同意后,报国家药品管理部门核准。
Designated production enterprises of ephedrine shall work out production plans for the following year (including supply plans for export) and submit them to the state department of pharmaceutical administration for verification and approval upon preliminary examination and consent of the departments of pharmaceutical administration of the provinces, autonomous regions and municipalities directly under the Central Government wherein the enterprises are located.

任何定点生产企业不得违反国家规定超计划生产麻黄素。
No designated production enterprise shall overproduce ephedrine beyond the plan in violation of state provisions.

未经国家药品管理部门批准,麻黄素定点生产企业不得以技术转让、联营、设分厂等形式扩大麻黄素的生产规模。
No designated production enterprise of ephedrine shall expand the production scale of ephedrine in the form of technology transfer, joint management or establishing branch plant without the approval of the state department of pharmaceutical administration.

两年内没有生产任务的定点企业,可以取消定点。
A designated enterprise without production task for two years may be nullified of its designation.

(二)加强麻黄素的经营管理。
(2) Strengthening ephedrine management control.

国家对麻黄素实行统购统销。
The State practices monopoly for the purchase and marketing of ephedrine.

国家药品管理部门要会同卫生部门研究制定麻黄素定点供应办法,报全国禁毒工作领导小组办公室备案。
The state department of pharmaceutical administration shall, in conjunction with the department of public health, study and formulate measures for the designated points for the supply of ephedrine and submit the same to the Office of the National Anti-drug Leading Group for the record.

未经指定的任何单位和个人,不得经营麻黄素业务。
No unit or individual without appointment shall operate ephedrine business.

使用麻黄素的制药、医疗和科研单位只能按规定到指定的麻黄素定点经营企业购买 。
Pharmaceutical, medical and scientific research units that use ephedrine can only make the purchase at the designated management enterprises of ephedrine appointed in accordance with provisions.

建立麻黄素购销核查制度。
Establishing ephedrine purchase and marketing verification rules.

购买麻黄素应先向省、自治区、直辖市药品管理部门提出书面申请,经审查同意后办理购用证明,并到指定的麻黄素定点经营企业购买。
An application in writing shall be filed at the department of pharmaceutical administration of a province, an autonomous region or a municipality directly under the Central Government for the purchase of ephedrine, a certificate for purchase and use obtained upon examination and approval and the purchase made at the designated management enterprise of ephedrine appointed.

麻黄素购用证明由国家药品管理部门统一印制,一证一次使用有效。
Certificates for ephedrine purchase and use shall be uniformly printed by the state department of pharmaceutical administration and one certificate shall be valid for a single use.

禁止倒卖和转让麻黄素购用证明。
Speculation and transfer of certificates for ephedrine purchase and use shall be prohibited.

麻黄素经营企业严禁向无购用证明的企业或个人销售麻黄素。
Management enterprises of ephedrine are strictly prohibited to sell ephedrine to any enterprise or individual without a certificate of purchase and use.

在麻黄素购销活动中禁止使用现金。
Use of cash shall be prohibited in the purchase and marketing activities of ephedrine.

(三)加强麻黄素的仓储和运输管理。
(3) Strengthening ephedrine warehouse and transport control.

麻黄素生产、经营企业必须建立严格的仓储制度,要设专用库房并指派专人管理。
Production and management enterprises of ephedrine must establish strict warehouse rules and should set aside special-purpose stock rooms and appoint special persons for the control thereof.

麻黄素的运输必须到省级公安机关办理运输许可证,由专人押运。
A transport permit must be obtained from the provincial public security organ for the transportation of ephedrine under escort by designated persons.

麻黄素运输许可证由公安部统一印制,一证一次使用有效。
Ephedrine transport permits shall be uniformly printed by the Ministry of Public Security and one certificate shall be valid for a single use.

(四)规范麻黄素的使用管理。
(4) Standardizing control over ephedrine use.

卫生部门要加强对麻黄素单方制剂的管理。
Departments of public health must enhance control over prescribed ephedrine preparations.

麻黄素单方制剂只能卖给医疗单位,医疗单位凭医生处方销售。
Prescribed ephedrine preparations can only be sold to medical units which shall sell on the strength of doctors’ prescriptions.

严禁社会各类医药商店及私人诊所经销麻黄素单方制剂。
All categories of pharmacies of society and private clinics are strictly prohibited to sell prescribed ephedrine preparations.

使用麻黄素及其单方制剂的单位要建立购买、使用、销毁的登记制度,严防麻黄素及其单方制剂流入非法渠道。
Units that use ephedrine and its prescribed preparations must establish registration rules for the purchase, use and destruction thereof to strictly prevent ephedrine and its prescribed preparations from getting into illegal channels.

(五)加强麻黄素的进出口管理。
(5) Stepping up ephedrine import-export control.

国家对麻黄素的出口实行许可证管理制度。
The State practices license control system for the export of ephedrine.

由外经贸部商国家药品管理部门确定麻黄素出口企业及出口计划;
Ephedrine export enterprises and export plan shall be determined by the Ministry of Foreign Trade and Economic Co-operation in consultation with the state department of pharmaceutical administration.

其他单位和个人一律不得从事麻黄素出口业务。
No other units or individuals shall engage in ephedrine export business.

麻黄素出口企业在申请办理出口手续时,须向外经贸部提交境外进口商所在国家、地区政府或政府委托机构出具的进口许可证及合同原件,经外经贸部审查同意,送全国禁毒工作领导小组办公室进行国际核查,确认合法后,由外经贸部签发麻黄素出口许可证。
An ephedrine export enterprise must, in applying for export formalities, present the import license issued by the government of the country, region or the agency entrusted by the government of the country, region in which the foreign import firm is located and the original of the contract to the Ministry of Foreign Trade and Economic Co-operation, upon examination and approval of the Ministry of Foreign Trade and Economic Co-operation, submit it to the Office of the National Anti-drug Leading Group for international verification, and upon confirmation as legal, be issued an ephedrine export license by the Ministry of Foreign Trade and Economic Co-operation.

麻黄素出口企业持外经贸部签发的麻黄素出口许可证及上述有关材料,到国家药品管理部门办理麻黄素出口购用证明,到指定的麻黄素定点经营企业购买。
An ephedrine export enterprise shall go through the formalities for the obtainment of the certificate of purchase and use for ephedrine export at the state department of pharmaceutical administration along with the ephedrine export license issued by the Ministry of Foreign Trade and Economic Co-operation and the afore-said materials and make the purchase at the designated ephedrine management enterprise appointed.

麻黄素出口购用证明由 国家药品管理部门统一印制,一证一次使用有效。
Certificates for purchase and use for ephedrine export shall be uniformly printed by the state department of pharmaceutical administration and one certificate shall be valid for a single use.

麻黄素出口企业须在麻黄素报关出运后30日内向外经贸部提交海关签注的出口许可证和出口货物报关单的复印件。
An ephedrine export enterprise must, within 30 days after the customs declaration and shipment of ephedrine, present to the Ministry of Foreign Trade and Economic Co-operation photocopies of the export license and export goods declaration form signed and annotated by customs.

因故未能在许可证有效期内出运的,须在出口许可证、出口购用证明有效期满后15日内将上述证明及时退回原发证单位。
An enterprise that has failed to effect the shipment within the validity of the license due to unforeseen reasons must, within 15 days after the expiry of the export license and the certificate of purchase and use for export, return the afore-said certificates to the original licensing units in time.

未经国家药品管理部门批准,不得擅自处理未出口的麻黄素。
The ephedrine not exported must not be disposed of without authorization and without the approval of the state department of pharmaceutical administration.

禁止倒卖和转让麻黄素出口许可证和出口购用证明。
Speculation and transfer of ephedrine export licenses and certificates of purchase and use for export are prohibited.

海关依法对麻黄素出口实行监管,凭麻黄素出口许可证验证放行。
Customs exercises supervision and control over ephedrine export and examines the license and issues customs clearance against the ephedrine export license.

麻黄素出口口岸由海关总署指定,非经海关总署指定的口岸,不准出口麻黄素。
Ports of ephedrine export shall be designated by the General Administration of Customs, ports not designated by the General Administration of Customs are not allowed to export ephedrine.

对旅客携带或个人邮寄麻黄素单方制剂出境的,海关凭卫生部门规定的特种医生处方查验放行。
With respect to passengers bringing or individuals sending by post prescribed ephedrine preparations out of the country, customs shall make inspection and examination and issues clearance against doctor’s special prescription specified by the department of public health.

从本通知下发之日起,一律不再进口麻黄素。
No ephedrine shall be imported any more under any circumstances as of the date of issuance of this Circular.

三、各级人民政府和有关部门要各负其责,加强协调与配合,共同做好对麻黄素的管理工作,依法严厉打击走私、贩卖麻黄素违法犯罪活动。
III. People’s governments at all levels and the departments concerned should assume their respective responsibilities, strengthen coordination and cooperation in jointly and successfully carrying out ephedrine control and sternly cracking down on illegal criminal activities of smuggling and trafficking ephedrine in accordance with law.

四、地方和部门以前下发的有关规定,凡与本通知不一致的,按本通知执行。
IV. Where relevant provisions previously issued by localities and departments are inconsistent with this Circular, this Circular shall prevail.

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