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国务院办公厅关于继续整顿和规范药品生产经营秩序加强药品管理工作的通知 CIRCULAR OF THE GENERAL OFFICE OF THE STATE COUNCIL CONCERNING CONTINUING TO RECTIFY AND REGULATE THE ORDER OF MEDICINE PRODUCTION AND SALE AND TO STRENGTHEN THE ADMINISTRATION OF MEDICINE

2006-05-15 23:30   我要纠错 | 打印 | 收藏 | | |

国办发(1996)14号
(April 16, 1996)
颁布日期:19960416  实施日期:19960416  颁布单位:国务院办公厅

  Since the issuance of the Urgent Circular of the State Council Concerning Further Strengthening the Administration of Medicine (hereinafter referred to as “Urgent Circular”), people's governments of provinces, autonomous regions and municipalities directly under the central government and the relevant departments under the State Council have been strengthening the leadership over the administration of medicine in accordance with the arrangement made by the State Council. Measures have been taken in the light of practical conditions to check up the administration of medicine within their own localities or departments. As a result, some unlawful trade fair markets for medicine have been banned, a number of units and individual businesses been punished for the unlawful production and sale of medicine, and disciplinary actions been taken against the law-breaking and criminal activities involving the production and sale off also and inferior medicine. Certain effectiveness has produced in rectifying and regulating the order of medicine production and sale. Nevertheless, we must notice that localities and departments do the work at much different paces. Serious problems regarding the administration of medicine have not been solved. Main facts can be enumerated as follows. There are someone continuing the unlawful production and sale of medicine without any licence or without all the required certificates, or with a licence rented or transferred from others. There are some trade fair markets for medicine still in operation, and others opening for business again without approval after being banned or changing their appearances to continue the unlawful medicine trade. Slow progress is made in rectifying and regulating special markets for Chinese traditional medicinal materials, some of which fail to meet the standards but have not yet been closed down. Prepared Chinese traditional medicine, prepared Western medicine and processed Chinese traditional medicine in ready-to-use forms are allowed to enter such markets by violating state provisions. A few localities go exclusively after their own benefits so that Law-breakers, being backed and connived at by some officials of local governments, commit without scruple the activities such as illegally producing and selling false and inferior medicine and establishing trade fair markets for medicine. A few departments hesitate about self-examination and rectification, take no effective measures and quarrel with each other instead of cooperating well. Especially, the demand for rebates prevails in the purchase and sale of medicine and the law-breaking activities of this kind are showing an unhealthy tendency with serious harmfulness. It's urgent to eliminate the low-level repeated production of medicine. Therefore, to strengthen the administration of medicine is still an arduous task which each locality and department concerned must attach great importance to. For the purposes of acting in the spirit of the “Urgent Circular”, continuing to rectify and regulate the order of medicine production and sale and strengthening the administration of medicine, the following matters are here by circulated with the approval of the State Council:

  1. People's governments at various levels and the relevant departments shall be fully aware of the importance of strengthening the administration of medicine.

  People's governments at various levels and the relevant departments shall be fully aware of the importance of strengthening the administration of medicine. They must deeply understand the work of importance to the health and lives of the people, to the social stability, and to the national economy and social development. Regard must be paid to the administration of medicine and the quality of medicine as well as the people's safe, effective, convenient and timely application of medicine. They must treat the work as a major issue in order to make some achievements. Facts have proved that, the work of rectifying and regulating the order of medicine production and sale and strengthening the administration of medicine depends on the understanding and determination of people's governments at various levels and their sense of responsibility to the people. Local people's governments at various levels and the relevant departments shall, proceeding from the general situation, strengthen the leadership and take effective measures in order to increase the force in rectifying and regulating the order of medicine production and sale and to punish the law-breaking and criminal activities strictly. They must fight against the local protectionism and ensure the application of state laws and government orders. Principal leaders of local people's governments at various levels and the relevant departments shall bear the responsibility for leading the administration of medicine within their own regions and departments. Local people's governments at or above the county level shall on their own initiatives report the administration of medicine in their respective regions to, and accept the supervision of, the standing committees of people's congresses at their corresponding levels. Supervisory departments of people's governments at various levels shall, in accordance with their functions and the relevant provisions, intensify the supervision over the enforcement of the Pharmaceutical Administration Law of the People's Republic of China (hereinafter referred to as the “Pharmaceutical Administration Law”) and the “Urgent Circular”。 In exercising the supervision over law enforcement, they shall make supervisory proposals for resolving problems they have found and shall impose administrative or disciplinary sanctions upon leading cadres who neglect duties, commit malfeasances, take advantage of their positions for personal gain, or commit other actions violating laws or disciplines. A higher level government shall examine seriously and appraise the administration of medicine conducted by a leading member of its lower level government during his period of office.

  2. Unlawful rebates in purchasing and selling medicine shall be investigated strictly.

  Recently, the demand and acceptance of unlawful rebates, or rebates in the form of discounts or price reductions, prevails in purchasing and selling medicine. This kind of illegal activities results in the loss of state taxes and unfair competition between enterprises, promotes the rise of medicine price, adds to the burdens of enterprises and patients, disturbs the social and economic order, corrupts a number of staff members and gives a chance of law-breaking and criminal activities of manufacturing and selling false and inferior medicine. It is necessary to make major efforts to conduct a thorough investigation. The relevant departments under the State Council shall cooperate closely with each other, coordinate their actions and take effective measures in order to investigate and punish seriously the law-breaking activities involving rebates and check resolutely the unhealthy tendency. By grasping the underlying reasons for this tendency, comprehensive measures shall be taken to eliminate such phenomena fundamentally.

  Administrative departments of health at various levels and administrative departments in charge of medicine production and sale shall, while building contingents and conducting the education in professional ethics, pay close attention to self-examination and rectification of demand for rebates in the purchase and sale of medicine throughout their own industries. They must also take further steps to establish and perfect the relevant rules and regulations for exercising strict control and stopping loopholes. Rebates found out by self-examination shall be handed over to the treasury department according to the relevant provisions.

  The State Council has decided to carry out a special inspection of the law-breaking activities involving rebates in the purchase and sale of medicine. The State Administration for Industry and Commerce has been ordered to organize the inspection in collaboration with such departments or organizations as the Ministry of Public Health, the State Administration of Medicine, the State Administration of Traditional Medicine and the State Council Office for Correcting Malpractices in All Trades and Professions and in accordance with a working plan they draw up together. A joint inspection group shall be established in order to make selective examinations of the production and sale of medicine in medicine producing and selling enterprises and medical institutions, with the focus of investigation on typical cases. Organizations or individuals under investigation shall, in addition to confiscation of rebates or other unlawful gains they accepted, be punished for demand for or acceptance of bribes. If a crime has been constituted, the judicial organs shall investigate the offender for criminal liabilities. Any organization or individual who commits an offence regardless of state prohibitions, if the circumstances are serious, shall be punished sternly and exposed by news media in order to frighten and educate offenders.

  For the purposes of dealing with the disorder of medicine prices and checking malpractices related to rebates, it is necessary to strengthen the control and supervision of medicine prices and to deepen the reform of medicine prices.

  Medical institutions shall separate the accounting of medical service income from that of medicine sale income and shall control them separately.

  3. The medicine supply in rural areas at the grass-roots level shall be controlled strictly in order to ensure the people the application of medicine.

  The main channel of medicine supply in rural areas at the grass-roots level shall be amplified and improved. Medicine needed by township's hospitals, village's clinics and private medical clinics in rural areas shall be planned by administrative departments of health at the county level in consultation with administrative departments in charge of medicine production and sale at the county level, and shall be supplied in a unified way by state-owned medicine (medicinal materials) companies at the county level. The supply of medicine to villages in some remote border areas that have not linked up with any supply network for the time being and are thinly populated shall be entrusted to township's hospitals or supply and marketing cooperatives in rural areas. The State Administration of Medicine and the State Administration of Traditional Medicine shall, within the period of this year, work out a detailed practical plan for completing the construction of national networks of medicine supply in rural areas before the year 2000 in order to ensure the people the safe, effective, convenient and timely application of medicine.

  Administrative departments of health of local people's governments at various levels shall finish the inspection of private medical clinics and the re-issuance of “Practising Permits” within the period of this year. They shall strengthen the supervision and administration of private medical clinics. Anyone who illegally sells medicine under the guise of practising medicine shall be banned and his “Practising Permit” be revoked.

  4. Law enforcement shall be intensified in order to rectify the order of medicine production and sale firmly.

  (1) Enterprises and individual businesses engaging in the medicine production and sale shall be strictly examined and controlled.

  The relevant departments under the State Council shall, based on the results of checking up and rectification conducted at the earlier stage, make strict self-examination and rectification of the administration of medicine in their own departments and shall make some achievements therein. People's governments at various levels and their administrative departments in charge of public health, medicine production and sale, and industry and commerce shall continue to organize forces to check up enterprises and individuals engaging in the medicine production and sale and shall revoke its qualification certificate and permit for medicine production and sale and business licence according to law if any of them violates the Pharmaceutical Administration Law, the Urgent Circular, and other relevant laws and regulations. Medicine producers and sellers without any licence or without all the required certificates shall be firmly banned by the administrative department of health that takes the lead and collaborates with the administrative department for industry and commerce, the administrative department in charge of medicine production and sale and the public security organ. Administrative departments in charge of medicine production and sale of people's governments of provinces, autonomous regions and municipalities directly under the central government shall supervise the self-examination conducted by state-owned medicine producing and selling enterprises. If a state-owned medicine producing and selling enterprise or its agency is contracted by an individual for business, or transfers or leases its permit or business licence to another person, such a situation shall be checked up and rectified within a fixed time limit. If the self-examination and rectification have not been completed upon the expiration, the person in charge of the medicine producing and selling enterprise and other persons involved shall be imposed upon disciplinary sanctions and even the qualification certificate and permit for medicine production and sale and business licence be revoked according to law. The tasks above-mentioned shall be finished before July 31, 1996.

  Local people's governments at various levels and the relevant departments shall further crack down on the law-breaking and criminal activities of producing and selling false and inferior medicine. They must treat the investigation and dealing with of cases involving the production and sale of false and inferior medicine as a major task in the anti-corruption struggle so as to make an achievement therein.

  (2) Medicine varieties and quality shall be controlled strictly and close attention be paid to the problem regarding the low-level repeated production of medicine.

  Recently, the low-level repeated production of medicine and the competition for imitating medicine of the same variety have obstructed the improvement of medicine quality and are detrimental to the research and development of new variety and the intellectual property protection of medicine producing enterprises. Such medicine production not only hinders the progress of medicine industrial modernization, but also aggravates the disorder of medicine production and sale.

  Administrative departments of health of people's governments of provinces, autonomous regions and municipalities directly under the central government shall check up and rectify the medicine production which have been approved and shall, during the period of such checking up and rectification, suspend the approval of imitating medicines and healthcare medicines which have been assigned registration numbers.

  If the protection of a variety of Chinese traditional medicine is applied for in accordance with the provisions of the “Regulations on the Protection of the varieties of Chinese Medicine”, the administrative department of health may not issue a registrated document of approval to other enterprises for the production of this variety of medicine during the period of time when the State Examining and Appraising Committee for the Protection of Chinese Medicine Varieties accepts the application and appraises the medicine variety. The administrative department in charge of medicine production and sale shall, in consultation with other competent departments, guide medicine producing enterprises in adjusting the structure of products in order to resolve as soon as possible the problem regarding the low-level repeated production of the same medicine variety.

  The administrative department of health shall, in consultation with other competent departments, organize an inspection of medicine quality of the same variety. Medicine inspection organs at various levels shall strengthen the inspection and selective examination of medicine quality. If a batch of medicines in stock for leaving factory does not meet the medicine standards of the state or of the province, autonomous region and municipality directly under the central government upon a selective examination, and does not meet the standards again when being re-examined, its registrated document of approval shall be resolutely withdrawn according to law.

  Medical units shall, in strict accordance with the provisions of the “Pharmaceutical Administration Law”, restrict medicinal preparations made by themselves to those which are used by themselves for clinical needs and in scientific research but cannot be supplied or adequately supplied on the market. They are not permitted to make any other medicinal preparation. It is prohibited to sell, or sell in a disguised form, medicinal preparations made by a medical unit on the market. If any medical unit has been found to sell or sell in a disguised form medicinal preparations on the market, it shall resolutely be disqualified from making medicinal preparations and its dispensing permit be revoked.

  In order to put an end to the repeated production of medicine due to excessive medicine producing enterprises, any medicine producing enterprise newly established shall be examined and approved by the Ministry of Public Health together with the State Administration of Medicine and the State Administration of Traditional Medicine before completing the formalities concerning the application, examination and approval according to the relevant provisions. The construction of new, expanded and reconstructed medicine producing enterprises or workshops shall conform to the Guidelines on Quality Control of Medicine Producing Enterprises (GMP) and shall pass the authentication before the issuance of the Qualification Certificate for Medicine Producing Enterprise and the Licence for Medicine Producing Enterprise. The Ministry of Public Health, the State Administration of Medicine and the State Administration of Traditional Medicine shall jointly work out a program me to rectify and transform within a fixed time limit enterprises that have not conformed to GMP. Enterprises that fail to meet the standards upon the expiration shall be closed down.

  (3) All trade fairs for medicine shall be banned and steps be sped up to rectify and regulate special markets for traditional medicinal materials.

  Local people's governments shall urge the competent departments to ban resolutely trade fairs for medicine according to law. All kinds of trade fairs for medicine, which operate under the guise of a medicine sales prohibition center, medicine information center, Chinese traditional medicine world, health food wholesale market, special market for traditional medicinal materials, etc., must be closed down. Problems arising from the work shall be resolved.

  The State Administration of Medicine, the State Administration of Traditional Medicine, the Ministry of Public Health, the State Administration for Industry and Commerce and local people's governments concerned shall speed up the rectification and regulation of special markets for traditional medicinal materials. Some special markets which are located in central areas growing traditional medicinal materials of major varieties in history, or in traditional distribution centers for medicinal materials shall be rectified and regulated in strict accordance with the provisions of the Circular Concerning the Issuance of the Standards for Rectifying Special Medicinal Materials Markets formulated jointly by the competent departments under the State Council (i.e. the Document guozhongyiyaosheng No. 7[1995], hereinafter referred to as the “Standards”)。 They must undergo the formalities regarding the report, examination, acceptance and approval as soon as possible in order to provide experience for rectifying and regulating special markets. Existing special markets, if they conform to the relevant provisions of the “Standards” through rectification, with permits and licences issued according to statutory procedures, may continue business and shall be managed strictly. Those not conforming to the “Standards” shall be closed down.

  The work of rectifying and regulating the order of medicine production and sale must be finished before September 30, 1996.

  People's governments of provinces, autonomous regions and municipalities directly under the central government and the relevant departments under the State Council shall take measures as required by this Circular and make Joint efforts to improve the administration of medicine. The relevant departments of people's governments at various levels shall cooperate and support each other and may not pass the buck to each other. The Ministry of Supervision, the Ministry of Public Health, the State Administration for Industry and Commerce, the State Administration of Medicine, the State Administration of Traditional Medicine and other competent departments shall organize a joint inspection group when necessary to make selective examinations of each locality's strengthening the administration of medicine by means of observation and investigation. The joint inspection group shall investigate local governments responsible for the disorder of the administration of medicine and leading members in charge of the relevant departments for corresponding liabilities according to law and shall issue circulars of criticism therefor.elevant departments for corresponding liabilities according to law and shall issue circulars of criticism therefor.elevant departments for corresponding liabilities according to law and shall issue circulars of criticism therefor.elevant departments for corresponding liabilities according to law and shall issue circulars of criticism therefor.elevant departments for corresponding liabilities according to law and shall issue circulars of criticism therefor.elevant departments for corresponding liabilities according to law and shall issue circulars of criticism therefor.

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