国务院关于进一步加强麻黄素管理的通知

国发19983号
(March 11, 1998)
颁布日期：19980311 　实施日期：19980311 　颁布单位：国务院

China is one of the major producing and exporting countries of natural ephedrine. Ephedrine is both the raw material for medicine and the precursor for making methamphetamine ("ice" drug). 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. 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. 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. 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:

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 practise the ephedrine control responsibility system. Strong measures should be taken for the sorting out and consolidation of enterprises producing and managing ephedrine; enterprises or units engaging in illegal production and management of ephedrine should be firmly banned according to law; 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.

II. The State practises the special-purpose control system with respect to the production, management, use and export of ephedrine (including extracts from ephedra grass and chemically synthesized, levorotatary 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.

(1) Planned production of ephedrine shall be carried out at designated points in fixed quantity.

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. No unit or individual without appointment shall engage in production activities of ephedrine.

The annual production plan of ephedrine shall be examined and finalized by the state department of pharmaceutical administration. 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 where in the enterprises are located. No designated production enterprise shall overproduce ephedrine beyond the plan in violation of state provisions.

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. A designated enterprise without production task for two years may be nullified of its designation.

(2) Strengthening ephedrine management control.

The State practises monopoly for the purchase and marketing of ephedrine. 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. No unit or individual without appointment shall operate ephedrine business. 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.

Establishing ephedrine purchase and marketing verification rules. 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. 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. Speculation and transfer of certificates for ephedrine purchase and use shall be prohibited.

Management enterprises of ephedrine are strictly prohibited to sell ephedrine to any enterprise or individual without a certificate of purchase and use. Use of cash shall be prohibited in the purchase and marketing activities of ephedrine.

(3) Strengthening ephedrine warehouse and transport control.

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. A transport permit must be obtained from the provincial public security organ for the transportation of ephedrine under escort by designated persons. Ephedrine transport permits shall be uniformly printed by the Ministry of Public Security and one certificate shall be valid for a single use.

(4) Standardizing control over ephedrine use.

Departments of public health must enhance control over prescribed ephedrine preparations. Prescribed ephedrine preparations can only be sold to medical units which shall sell on the strength of doctors' prescriptions. All categories of pharmacies of society and private clinics are strictly prohibited to sell prescribed ephedrine preparations.

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.

(5) Stepping up ephedrine import-export control.

The State practises licence control system for the export of ephedrine. 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. No other units or individuals shall engage in ephedrine export business.

An ephedrine export enterprise must, in applying for export formalities, present the import licence 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 licence by the Ministry of Foreign Trade and Economic Co-operation.

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 exportlicence 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. 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.

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 licence and export goods declaration form signed and annotated by customs. An enterprise that has failed to effect the shipment within the validity of the licence due to unforeseen reasons must, within 15 days after the expiry of the export licence and the certificate of purchase and use for export, return the afore-said certificates to the original licensing units in time. The ephedrine not exported must not be disposed of without authorization and without the approval of the state department of pharmaceutical administration. Speculation and transfer of ephedrine export licences and certificates of purchase and use for export are prohibited.

Customs exercises supervision and control over ephedrine export and examines the licence and issues customs clearance against the ephedrine export licence. 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. 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.

No ephedrine shall be imported any more under any circumstances as of the date of issuance of this Circular.

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.

IV. Where relevant provisions previously issued by localities and departments are inconsistent with this Circular, this Circular shall prevail.