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.
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.
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.
(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.
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.
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.
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.