国务院关于进一步加强药品管理工作的紧急通知 URGENT CIRCULAR CONCERNING FURTHER STRENGTHENING THE ADMINISTRATION OF MEDICIN

ine-selling enterprise”。 Then they may apply to the department for the administration of health at the same level for the “permit certificate for medicine-producing enterprise” or the “permit certificate for the medicine-selling enterprise”。 Without the “qualification certificate for medicine-producing enterprise”， or the “qualification certificate for medicine-selling enterprise” issued by the department in charge of the production and sale of medicine upon examination and agreement， the department for the administration of health shall not accept the application. Without obtaining the “qualification certificate for medicine-producing enterprise”， the “permit certificate for medicine-producing enterprise” or the “qualification certificate for medicine-selling enterprise”， the “permit certificate for medicine-selling enterprise”， the department for the administration of industry and commerce shall not check and issue the business license.

　　The applications for retail of medicine business by enterprises， or individual industry and commerce， shall be examined by the departments in charge of the production and sale of medicine under the people's governments of the autonomous prefectures， cities or counties， according to the needs for medicine and the program for the retail of medicine network within their regions， and if agreed upon examination， the “qualification certificate for medicine-selling enterprise” shall be issued. The retail of medicine enterprise， and the individual industry and commerce， shall take the “qualification certificate for medicine-selling enterprise” to the departments for the administration of health at the same level for application and， after obtaining the “permit certificate for medicine-selling enterprise”， may apply to the departments for the administration of industry and commerce for the issuance of the business license.

　　Certificates and licenses that have not been issued according to the procedures for examination and approval referred to above by the departments in charge of the production and sale of medicine， the departm

ents for the administration of health and the departments for the administration of industry and commerce， become invalid， and the losses caused therefrom shall be compensated by the issuing departments according to law， and the persons in charge who are directly responsible and the persons directly responsible shall be investigated for responsibility.

　　（2） The order for medicine production and sale should be rectified and standardized， and the administration of the sale of medicine shall be strengthened according to law.

　　Those who have not obtained， according to law， the “qualification certificate for medicine-producing enterprise”， the “permit certificate for medicine-producing enterprise” or the “qualification certificate for medicine-selling enterprise”， the “permit certificate for medicine-selling enterprise” and the business license， shall not be engaged in the production and sale of medicine. The units and individuals engaged on their own decision in the production and wholesale of medicine shall be resolutely banned. Enterprises engaged in the production and wholesale distribution of medicine shall not be contracted by individuals for business.

　　Medical institutions and medicine-selling enterprises must purchase medicine from enterprises that have obtained lawful qualifications for medicine production and sales， and are strictly prohibited from purchasing medicine from unlawful dealers.

　　The supply of medicine to medical clinics in rural areas shall be the responsibility of the medicine wholesalers and the township's hospital entrusted by the wholesalers jointly appointed by the departments in charge of medicine production and sales and those for the administration of health under the local people's governments at the county level.

　　The preparations manufactured by medical institutions are limited to those needed for clinical purposes and scientific research conducted by the units themselves， and which are not supplied or inadequately supplied in the markets. The sale in a disguised manner of such products shall be strictly prohibited. Medical institutions shall not， in any disguised manner， engage in the wholesale business.

　　Fair competition shall be practiced in the purchase and sale of medicine between the production and management of medicine enterprises and medical institutions， and in purchases and sales， malpractices such as rebates， or bribery and requesting bribes are prohibited.

　　Departments responsible for the administration of health shall strictly examine the contents of publicity materials and advertisements and in coordination with the relevant departments， shall， according to law， punish illegal acts such as advertising medicine in violation of regulations， unfounded propaganda regarding effectiveness and other acts which mislead patients.

　　（3） The specialized markets for the traditional Chinese herbs should be rectified and standardized.

　　The state prohibits the setting up of trade fair markets for medicine， except specialized markets for traditional Chinese herbs， and prohibits in the specialized markets for traditional Chinese herbs the sale of traditional Chinese herbs and ready-made medicine， tablets of Chinese herbs， medicine of chemical raw materials and its preparations， antibiotics， biochemical medicine， radiate medicine， serum vaccine， blood products and diagnostic medicine of which sales are restricted as stipulated by the state.

　　The specialized markets for traditional Chinese herbs must be set up in selected principal producing or distributing places of traditional Chinese herbs according to overall plans drawn up by the department under the State Council in charge of production and sales of medicine， and must also be examined and approved by the department in charge of the production and sales of medicine， the department for the administration of health and the department for the administration of in

dustry and commerce under the State Council. The local people's governments at various levels and the other departments are not authorized to examine and approve the establishment of specialized markets for traditional Chinese herbs.

　　The existing specialized markets for traditional Chinese herbs shall be rectified， and the criteria shall be formulated by the department in charge of the production and sales of medicine， the department for the administration of health and the department for the administration of industry and commerce under the State Council. Specialized markets for traditional Chinese herbs which have already been set up but are not in compliance with the criteria shall be closed without exception. Any other trade fair markets for medicine except specialized markets for traditional Chinese herbs that have been set up without proper authorization shall be banned according to law by the local people's governments.

　　Traditional Chinese herbs being sold in trade fair markets for agricultural products shall be supervised strictly by the department for the administration of health. Those who sell types of traditional Chinese herbs on their own decision that are prohibited by the state from being sold and the medicine other than the traditional Chinese herbs without certificate in trade fair markets for agricultural products in violation of the “Law on the Administration of Medicine” shall be investigated and punished by the relevant departments according to the provisions of the “Law on the Administration of Medicine”。

　　（4） The protection for the intellectual property rights for medicine shall be strengthened， and enterprises are encouraged to research in and develop new medicine.

　　The department for administration of health and the department in charge of the production and sales of medicine under the State Council， shall develop practical plans for encouraging enterprises， scientific research units， universities and colleges to promote research and develop new medicine.

　　The “Regulations on the Protection of the Types of Chinese Medicine” issued by the State Council shall be further implemented in various places. The types of Chinese medicine already listed for national protection shall not be imitated and manufactured by enterprises without the protection certificate. The relevant departments and examining and appraising organs shall conscientiously do a good job to protect the types of Chinese medicine in order to promote development of Chinese medicine.

　　3. There should be an intensified crackdown on criminal activities involving the production and sales of false and inferior medicine. In addition， investigations should be conducted into cases involving violations of law and discipline with regard to the production and sales of false and inferior medicine. These activities shall be considered of great importance with regard to combating corruption.

　　In order to check resolutely law-breaking and criminal activities in producing and selling false and inferior medicine， local people's governments at various levels and the relevant departments， shall carry on further blows on the law-breaking and criminal activities in producing and selling false and inferior medicine. In cracking severely the law-breaking and criminal activities in producing and selling false and inferior medicine， they should strictly enforce laws and intensify law enforcement regarding these issues. The national and local coordinating institutions for “striking the false” at various levels shall organize the relevant departments of health， medicine， administration of industry and commerce， technical supervision and public security in investigating into and dealing with the law-break

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