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國務院關于進一步加強麻黃素管理的通知(中英對照)

放大字體  縮小字體 發(fā)布日期:2006-12-27
Circular of the State Council Concerning Further Strengthening Ephedrine Control

 

我國是天然麻黃素的主要生產國和出口國之一。
China is one of the major producing and exporting countries of natural ephedrine.

麻黃素既是制藥原料,又是制造甲基苯丙胺(“冰”毒)的前體。
Ephedrine is both the raw material for medicine and the precursor for making methamphetamine ("ice" drug).

近年來,國際販毒集團與國內販毒分子相互勾結,將麻黃素大量走私販運出境,或以投資辦廠、合資制藥、生產民用化學品等為名,在國內非法加工制造“冰”毒,將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.

少數地方和部門為了追求經濟利益,違反國家有關規(guī)定,大量生產、經營麻黃素,給不法分子制做“冰”毒以可乘之機。
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.

這種情況已引起國際社會特別是國際禁毒組織的關注,有損我國的國際形象。
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.

為進一步加強麻黃素的管理工作,防止麻黃素流入非法渠道,保障人民身體健康,現就有關問題通知如下:
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、各級人民政府和有關部門要提高認識,切實加強對麻黃素管理工作的領導,嚴格執(zhí)行國家法律、法規(guī),落實麻黃素管理責任制。
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,對現有生產、經營麻黃素的企業(yè)進行清理整頓;
Strong measures should be taken for the sorting out and consolidation of enterprises producing and managing ephedrine;

對非法生產、經營麻黃素的企業(yè)或單位,堅決依法取締;
enterprises or units engaging in illegal production and management of ephedrine should be firmly banned according to law;

對因管理不善使麻黃素流入非法渠道的生產、經營企業(yè)堅決取消其生產、經營資格并依法追究有關部門和單位直接責任人員的法律責任。
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、國家對麻黃素(含從麻黃草提取和化學合成的,包括左、右旋)及其鹽類如鹽酸麻黃 素、草酸麻黃素、硫酸麻黃素和麻黃素粗品(含麻黃浸膏、麻黃浸膏粉、麻黃草粉)、麻黃素衍生物以及以麻黃素為原料生產的單方制劑等的生產、經營、使用、出口實行專項管理制度 。
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)對麻黃素實行定點、定量、計劃生產。
(1) Planned production of ephedrine shall be carried out at designated points in fixed quantity.

麻黃素定點生產企業(yè)由國家藥品管理部門指定,報全國禁毒工作領導小組辦公室備案。
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.

未經指定的任何單位和個人,不得從事麻黃素的生產活動。
No unit or individual without appointment shall engage in production activities of ephedrine.

麻黃素的年度生產計劃由國家藥品管理部門審定。
The annual production plan of ephedrine shall be examined and finalized by the state department of pharmaceutical administration.

麻黃素定點生產企業(yè)制訂下一年度的生產計劃(包括供應出口計劃),經所在省、自治區(qū)、直轄市藥品管理部門初審同意后,報國家藥品管理部門核準。
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.

任何定點生產企業(yè)不得違反國家規(guī)定超計劃生產麻黃素。
No designated production enterprise shall overproduce ephedrine beyond the plan in violation of state provisions.

未經國家藥品管理部門批準,麻黃素定點生產企業(yè)不得以技術轉讓、聯(lián)營、設分廠等形式擴大麻黃素的生產規(guī)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.

兩年內沒有生產任務的定點企業(yè),可以取消定點。
A designated enterprise without production task for two years may be nullified of its designation.

(二)加強麻黃素的經營管理。
(2) Strengthening ephedrine management control.

國家對麻黃素實行統(tǒng)購統(tǒng)銷。
The State practices monopoly for the purchase and marketing of ephedrine.

國家藥品管理部門要會同衛(wèi)生部門研究制定麻黃素定點供應辦法,報全國禁毒工作領導小組辦公室備案。
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.

未經指定的任何單位和個人,不得經營麻黃素業(yè)務。
No unit or individual without appointment shall operate ephedrine business.

使用麻黃素的制藥、醫(yī)療和科研單位只能按規(guī)定到指定的麻黃素定點經營企業(yè)購買 。
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.

建立麻黃素購銷核查制度。
Establishing ephedrine purchase and marketing verification rules.

購買麻黃素應先向省、自治區(qū)、直轄市藥品管理部門提出書面申請,經審查同意后辦理購用證明,并到指定的麻黃素定點經營企業(yè)購買。
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.

麻黃素購用證明由國家藥品管理部門統(tǒng)一印制,一證一次使用有效。
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.

禁止倒賣和轉讓麻黃素購用證明。
Speculation and transfer of certificates for ephedrine purchase and use shall be prohibited.

麻黃素經營企業(yè)嚴禁向無購用證明的企業(yè)或個人銷售麻黃素。
Management enterprises of ephedrine are strictly prohibited to sell ephedrine to any enterprise or individual without a certificate of purchase and use.

在麻黃素購銷活動中禁止使用現金。
Use of cash shall be prohibited in the purchase and marketing activities of ephedrine.

(三)加強麻黃素的倉儲和運輸管理。
(3) Strengthening ephedrine warehouse and transport control.

麻黃素生產、經營企業(yè)必須建立嚴格的倉儲制度,要設專用庫房并指派專人管理。
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.

麻黃素的運輸必須到省級公安機關辦理運輸許可證,由專人押運。
A transport permit must be obtained from the provincial public security organ for the transportation of ephedrine under escort by designated persons.

麻黃素運輸許可證由公安部統(tǒng)一印制,一證一次使用有效。
Ephedrine transport permits shall be uniformly printed by the Ministry of Public Security and one certificate shall be valid for a single use.

(四)規(guī)范麻黃素的使用管理。
(4) Standardizing control over ephedrine use.

衛(wèi)生部門要加強對麻黃素單方制劑的管理。
Departments of public health must enhance control over prescribed ephedrine preparations.

麻黃素單方制劑只能賣給醫(yī)療單位,醫(yī)療單位憑醫(yī)生處方銷售。
Prescribed ephedrine preparations can only be sold to medical units which shall sell on the strength of doctors’ prescriptions.

嚴禁社會各類醫(yī)藥商店及私人診所經銷麻黃素單方制劑。
All categories of pharmacies of society and private clinics are strictly prohibited to sell prescribed ephedrine preparations.

使用麻黃素及其單方制劑的單位要建立購買、使用、銷毀的登記制度,嚴防麻黃素及其單方制劑流入非法渠道。
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)加強麻黃素的進出口管理。
(5) Stepping up ephedrine import-export control.

國家對麻黃素的出口實行許可證管理制度。
The State practices license control system for the export of ephedrine.

由外經貿部商國家藥品管理部門確定麻黃素出口企業(yè)及出口計劃;
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.

其他單位和個人一律不得從事麻黃素出口業(yè)務。
No other units or individuals shall engage in ephedrine export business.

麻黃素出口企業(yè)在申請辦理出口手續(xù)時,須向外經貿部提交境外進口商所在國家、地區(qū)政府或政府委托機構出具的進口許可證及合同原件,經外經貿部審查同意,送全國禁毒工作領導小組辦公室進行國際核查,確認合法后,由外經貿部簽發(fā)麻黃素出口許可證。
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.

麻黃素出口企業(yè)持外經貿部簽發(fā)的麻黃素出口許可證及上述有關材料,到國家藥品管理部門辦理麻黃素出口購用證明,到指定的麻黃素定點經營企業(yè)購買。
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.

麻黃素出口購用證明由 國家藥品管理部門統(tǒng)一印制,一證一次使用有效。
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.

麻黃素出口企業(yè)須在麻黃素報關出運后30日內向外經貿部提交海關簽注的出口許可證和出口貨物報關單的復印件。
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.

因故未能在許可證有效期內出運的,須在出口許可證、出口購用證明有效期滿后15日內將上述證明及時退回原發(fā)證單位。
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.

未經國家藥品管理部門批準,不得擅自處理未出口的麻黃素。
The ephedrine not exported must not be disposed of without authorization and without the approval of the state department of pharmaceutical administration.

禁止倒賣和轉讓麻黃素出口許可證和出口購用證明。
Speculation and transfer of ephedrine export licenses and certificates of purchase and use for export are prohibited.

海關依法對麻黃素出口實行監(jiān)管,憑麻黃素出口許可證驗證放行。
Customs exercises supervision and control over ephedrine export and examines the license and issues customs clearance against the ephedrine export license.

麻黃素出口口岸由海關總署指定,非經海關總署指定的口岸,不準出口麻黃素。
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.

對旅客攜帶或個人郵寄麻黃素單方制劑出境的,海關憑衛(wèi)生部門規(guī)定的特種醫(yī)生處方查驗放行。
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.

從本通知下發(fā)之日起,一律不再進口麻黃素。
No ephedrine shall be imported any more under any circumstances as of the date of issuance of this Circular.

三、各級人民政府和有關部門要各負其責,加強協(xié)調與配合,共同做好對麻黃素的管理工作,依法嚴厲打擊走私、販賣麻黃素違法犯罪活動。
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、地方和部門以前下發(fā)的有關規(guī)定,凡與本通知不一致的,按本通知執(zhí)行。
IV. Where relevant provisions previously issued by localities and departments are inconsistent with this Circular, this Circular shall prevail.

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