我國(guó)是天然麻黃素的主要生產(chǎn)國(guó)和出口國(guó)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(lái),國(guó)際販毒集團(tuán)與國(guó)內(nèi)販毒分子相互勾結(jié),將麻黃素大量走私販運(yùn)出境,或以投資辦廠、合資制藥、生產(chǎn)民用化學(xué)品等為名,在國(guó)內(nèi)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(shù)地方和部門(mén)為了追求經(jīng)濟(jì)利益,違反國(guó)家有關(guān)規(guī)定,大量生產(chǎn)、經(jīng)營(yíng)麻黃素,給不法分子制做“冰”毒以可乘之機(jī)。
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(guó)際社會(huì)特別是國(guó)際禁毒組織的關(guān)注,有損我國(guó)的國(guó)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(jìn)一步加強(qiáng)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(xiàn)就有關(guān)問(wèn)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(jí)人民政府和有關(guān)部門(mén)要提高認(rèn)識(shí),切實(shí)加強(qiáng)對(duì)麻黃素管理工作的領(lǐng)導(dǎo),嚴(yán)格執(zhí)行國(guó)家法律、法規(guī),落實(shí)麻黃素管理責(zé)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(duì)現(xiàn)有生產(chǎn)、經(jīng)營(yíng)麻黃素的企業(yè)進(jìn)行清理整頓;
Strong measures should be taken for the sorting out and consolidation of enterprises producing and managing ephedrine;
對(duì)非法生產(chǎn)、經(jīng)營(yíng)麻黃素的企業(yè)或單位,堅(jiān)決依法取締;
enterprises or units engaging in illegal production and management of ephedrine should be firmly banned according to law;
對(duì)因管理不善使麻黃素流入非法渠道的生產(chǎn)、經(jīng)營(yíng)企業(yè)堅(jiān)決取消其生產(chǎn)、經(jīng)營(yíng)資格并依法追究有關(guān)部門(mén)和單位直接責(zé)任人員的法律責(zé)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(guó)家對(duì)麻黃素(含從麻黃草提取和化學(xué)合成的,包括左、右旋)及其鹽類(lèi)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(chǎn)的單方制劑等的生產(chǎn)、經(jīng)營(yíng)、使用、出口實(shí)行專(zhuān)項(xiàng)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(duì)麻黃素實(shí)行定點(diǎn)、定量、計(jì)劃生產(chǎn)。
(1) Planned production of ephedrine shall be carried out at designated points in fixed quantity.
麻黃素定點(diǎn)生產(chǎn)企業(yè)由國(guó)家藥品管理部門(mén)指定,報(bào)全國(guó)禁毒工作領(lǐng)導(dǎo)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(jīng)指定的任何單位和個(gè)人,不得從事麻黃素的生產(chǎn)活動(dòng)。
No unit or individual without appointment shall engage in production activities of ephedrine.
麻黃素的年度生產(chǎn)計(jì)劃由國(guó)家藥品管理部門(mén)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(diǎn)生產(chǎn)企業(yè)制訂下一年度的生產(chǎn)計(jì)劃(包括供應(yīng)出口計(jì)劃),經(jīng)所在省、自治區(qū)、直轄市藥品管理部門(mén)初審?fù)夂螅瑘?bào)國(guó)家藥品管理部門(mén)核準(zhǔn)。
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(diǎn)生產(chǎn)企業(yè)不得違反國(guó)家規(guī)定超計(jì)劃生產(chǎn)麻黃素。
No designated production enterprise shall overproduce ephedrine beyond the plan in violation of state provisions.
未經(jīng)國(guó)家藥品管理部門(mén)批準(zhǔn),麻黃素定點(diǎn)生產(chǎn)企業(yè)不得以技術(shù)轉(zhuǎn)讓、聯(lián)營(yíng)、設(shè)分廠等形式擴(kuò)大麻黃素的生產(chǎn)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(nèi)沒(méi)有生產(chǎn)任務(wù)的定點(diǎn)企業(yè),可以取消定點(diǎn)。
A designated enterprise without production task for two years may be nullified of its designation.
(二)加強(qiáng)麻黃素的經(jīng)營(yíng)管理。
(2) Strengthening ephedrine management control.
國(guó)家對(duì)麻黃素實(shí)行統(tǒng)購(gòu)統(tǒng)銷(xiāo)。
The State practices monopoly for the purchase and marketing of ephedrine.
國(guó)家藥品管理部門(mén)要會(huì)同衛(wèi)生部門(mén)研究制定麻黃素定點(diǎn)供應(yīng)辦法,報(bào)全國(guó)禁毒工作領(lǐng)導(dǎo)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(jīng)指定的任何單位和個(gè)人,不得經(jīng)營(yíng)麻黃素業(yè)務(wù)。
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(diǎn)經(jīng)營(yíng)企業(yè)購(gòu)買(mǎi) 。
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(gòu)銷(xiāo)核查制度。
Establishing ephedrine purchase and marketing verification rules.
購(gòu)買(mǎi)麻黃素應(yīng)先向省、自治區(qū)、直轄市藥品管理部門(mén)提出書(shū)面申請(qǐng),經(jīng)審查同意后辦理購(gòu)用證明,并到指定的麻黃素定點(diǎn)經(jīng)營(yíng)企業(yè)購(gòu)買(mǎi)。
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(gòu)用證明由國(guó)家藥品管理部門(mén)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(mài)和轉(zhuǎn)讓麻黃素購(gòu)用證明。
Speculation and transfer of certificates for ephedrine purchase and use shall be prohibited.
麻黃素經(jīng)營(yíng)企業(yè)嚴(yán)禁向無(wú)購(gòu)用證明的企業(yè)或個(gè)人銷(xiāo)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(gòu)銷(xiāo)活動(dòng)中禁止使用現(xiàn)金。
Use of cash shall be prohibited in the purchase and marketing activities of ephedrine.
(三)加強(qiáng)麻黃素的倉(cāng)儲(chǔ)和運(yùn)輸管理。
(3) Strengthening ephedrine warehouse and transport control.
麻黃素生產(chǎn)、經(jīng)營(yíng)企業(yè)必須建立嚴(yán)格的倉(cāng)儲(chǔ)制度,要設(shè)專(zhuān)用庫(kù)房并指派專(zhuān)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(yùn)輸必須到省級(jí)公安機(jī)關(guān)辦理運(yùn)輸許可證,由專(zhuān)人押運(yùn)。
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(yùn)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(mén)要加強(qiáng)對(duì)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(mài)給醫(yī)療單位,醫(yī)療單位憑醫(yī)生處方銷(xiāo)售。
Prescribed ephedrine preparations can only be sold to medical units which shall sell on the strength of doctors’ prescriptions.
嚴(yán)禁社會(huì)各類(lèi)醫(yī)藥商店及私人診所經(jīng)銷(xiāo)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(gòu)買(mǎi)、使用、銷(xiāo)毀的登記制度,嚴(yán)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(qiáng)麻黃素的進(jìn)出口管理。
(5) Stepping up ephedrine import-export control.
國(guó)家對(duì)麻黃素的出口實(shí)行許可證管理制度。
The State practices license control system for the export of ephedrine.
由外經(jīng)貿(mào)部商國(guó)家藥品管理部門(mén)確定麻黃素出口企業(yè)及出口計(jì)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(gè)人一律不得從事麻黃素出口業(yè)務(wù)。
No other units or individuals shall engage in ephedrine export business.
麻黃素出口企業(yè)在申請(qǐng)辦理出口手續(xù)時(shí),須向外經(jīng)貿(mào)部提交境外進(jìn)口商所在國(guó)家、地區(qū)政府或政府委托機(jī)構(gòu)出具的進(jìn)口許可證及合同原件,經(jīng)外經(jīng)貿(mào)部審查同意,送全國(guó)禁毒工作領(lǐng)導(dǎo)小組辦公室進(jìn)行國(guó)際核查,確認(rèn)合法后,由外經(jīng)貿(mào)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(jīng)貿(mào)部簽發(fā)的麻黃素出口許可證及上述有關(guān)材料,到國(guó)家藥品管理部門(mén)辦理麻黃素出口購(gòu)用證明,到指定的麻黃素定點(diǎn)經(jīng)營(yíng)企業(yè)購(gòu)買(mǎi)。
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(gòu)用證明由 國(guó)家藥品管理部門(mén)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(bào)關(guān)出運(yùn)后30日內(nèi)向外經(jīng)貿(mào)部提交海關(guān)簽注的出口許可證和出口貨物報(bào)關(guān)單的復(fù)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(nèi)出運(yùn)的,須在出口許可證、出口購(gòu)用證明有效期滿(mǎn)后15日內(nèi)將上述證明及時(shí)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(jīng)國(guó)家藥品管理部門(mén)批準(zhǔn),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(mài)和轉(zhuǎn)讓麻黃素出口許可證和出口購(gòu)用證明。
Speculation and transfer of ephedrine export licenses and certificates of purchase and use for export are prohibited.
海關(guān)依法對(duì)麻黃素出口實(shí)行監(jiān)管,憑麻黃素出口許可證驗(yàn)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(guān)總署指定,非經(jīng)海關(guān)總署指定的口岸,不準(zhǔn)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(duì)旅客攜帶或個(gè)人郵寄麻黃素單方制劑出境的,海關(guān)憑衛(wèi)生部門(mén)規(guī)定的特種醫(yī)生處方查驗(yàn)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(jìn)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(jí)人民政府和有關(guān)部門(mén)要各負(fù)其責(zé),加強(qiáng)協(xié)調(diào)與配合,共同做好對(duì)麻黃素的管理工作,依法嚴(yán)厲打擊走私、販賣(mài)麻黃素違法犯罪活動(dòng)。
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(mén)以前下發(fā)的有關(guān)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.