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中华人民共和国药品管理法实施办法

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中华人民共和国药品管理法实施办法
MEASURES FOR THE IMPLEMENTATION OF THE PHARMACEUTICAL ADMINISTRA-TION LAW OF THE PEOPLE'S REPUBLIC OF CHINA

(Approved by the State Council on January 7, 1989 and promulgated by the Ministry of Public Health by Decree No. 1 on February 27, 1989)
颁布日期:19890227  实施日期:19890227  颁布单位:国务院、 卫生部

  Chapter I General Provisions

  Article 1 These Measures are formulated in accordance with the Pharmaceutical Administration Law of the People's Republic of China (hereinafter referred to as Pharmaceutical Administration Law)。

  Article 2 These Measures are applicable to any units or individuals who are related to the production, selling, using, testing and examination or scientific research of medicines. These Measures are also applicable to the pharmaceutical enterprises in the People's Liberation Army that are engaged in the production of medicines for civilian use.

  Article 3 In the production and selling of pharmaceuticals, social benefit shall be taken as the prime concern. The production, selling or use of fake or inferior medicines is strictly prohibited.

  Without authorization no production or sales of pharmaceuticals or preparation of medicaments shall be allowed.

  Chapter II Responsibility for the Supervision and Administration of Pharmaceuticals

  Article 4 The administrative department of health under the State Council is in charge of the nationwide supervision over and administration of pharmaceuticals. Its principal responsibilities are as follows:

  (1) to enforce the pharmaceutical Administration Law and these Measures;

  (2) to draft laws and regulations related to the supervision and administration of pharmaceuticals, and to formulate provisions for the implementation of each law or regulations;

  (3) to promulgate the Pharmacopoeia of China and the national standards for medicines;

  (4) to examine and approve new medicines and to verify and issue approval certificates thereof;

  (5) to exercise supervision over the production, trading and use of pharmaceuticals;

  (6) to make investigation and appraisal of the curative effect and side effect of the medicines already put into production and to provide and publish information related to the quality;

  (7) to make decisions on disciplinary sanctions in accordance with the pharmaceutical Administration Law and these Measures.

  Pharmaceutical administration organs in the administrative departments of health at or above the county level are in charge of the supervision over and administration of pharmaceuticals within their respective jurisdiction.

  Article 5 The medicine inspection organs set up by the administrative departments of health at or above the county level shall, under the latter's leadership, conduct medicine inspection in accordance with the standards for medicines set by the state and by the administrative department of health at the level of province, autonomous region or municipality directly under the Central Government.

  Article 6 Medicine supervisor(s) shall be appointed in the administrative department of health at or above the county level. Medicine supervisors at the state level shall be entrusted by the administrative department of health under the State Council by credentials. Medicine supervisors at the provincial, autonomous region or municipal government (directly under the Central Government) level and at the autonomous prefecture, municipality or county level shall be nominated respectively by the administrative departments of health and entrusted with credentials by the people's governments at the corresponding levels. The duties of medicine supervisors at all levels shall be defined separately by the administrative department of health under the State Council.

  Article 7 When carrying out their duties, the medicine supervisors are required to present their credentials before they take sample testing and ask for relevant technical data, with a receipt in accordance with the state stipulations. They are required to keep confidential the technical data provided by the production enterprise and scientific research unit. The medicine supervisors may temporarily seal up some medicine pending further settlement. It is required of them to state the term of sealing up which shall not normally exceed 15 days.

  Chapter III Procedure for the Verification and Approval of Licenses

  Article 8 The procedures for examination and approval as stipulated in Paragraph 1 of Article 4 of the Pharmaceutical Administration Law denote that the establishment of a pharmaceutical producing enterprise (including all forms of inland associated enterprises, Chinese-foreign equity joint ventures and contractual joint ventures and foreign invested enterprises) shall involve, in addition to applying for approval for the capital construction of the enterprise in accordance with state stipulation, the following steps:

  (1) the enterprise or its leadership organ submits an application to the competent department for the production and trading of pharmaceuticals of the province, autonomous region or municipality directly under the Central Government where the enterprise is located for examination and approval and then refer it to the administrative department of health at the same level.

  (2) upon approval by the administrative department of health of the province, autonomous region or municipality directly under the Central Government, a Pharmaceutical Producer License shall be issued. The department in charge of the production and trading of pharmaceuticals and the administrative department of health are required to make a decision within 30 days of receipt of complete application materials.

  Article 9 If a pharmaceutical production enterprise desires to set up a branch factory or any additional workshops outside the premise of the factory, it is required to submit an application to the department in charge of the production and trading of pharmaceuticals at the level of the province, autonomous region or municipality directly under the Central Government for examination and approval and then refer it to the administrative department of health at the same level for a Pharmaceutical Producers License, on which the status of the new set-up (a branch factory or a workshop) and its production scope must be clearly stated.

  Article 10 The procedures for examination and approval stipulated in Paragraph 1 of Article 10 of the Pharmaceutical Administration Law denote that a pharmaceutical trading enterprise (including specialized and non- specialized whole-sale or retail drug stores or companies) should apply for a Pharmaceutical Trading Enterprise License in accordance with the following provisions:

  (1) for a wholesale drug enterprise, an application must be submitted to the department in charge of the production and trading of pharmaceuticals at the level of the province, autonomous region or municipality directly under the Central Government for examination and approval and then be referred to the administrative department of health at the same government level for verification and approval before a Pharmaceutical Trading Enterprise License is issued;

  (2) for a retail drug enterprise, an application must be submitted to the department in charge of the production and trading of pharmaceuticals at the autonomous prefecture, municipality or county government level for examination and approval and then be referred to the administrative department of health at the same government level for verification and approval before a Pharmaceutical Trading Enterprise License is issued. The department in charge of the production and trading of pharmaceuticals and the administrative department of health are required to make a decision within 30 days of receipt of complete application materials.

  Article 11 The competent department for the production and trading of pharmaceuticals stated in Articles 4, 10 and 22 of the Pharmaceutical Administration Law refers to those pharmaceutical administration organs or departments appointed by the people's government at or above the county level.

  Article 12 If a medical treatment unit needs to prepare some medicaments, it is required to submit an application to an administrative department of health at the level of the province, autonomous region or municipality directly under the Central Government for examination and approval before a Dispensing Permit is granted.

  The administrative department of health is required to make a decision within 30 days of receipt of complete application materials.

  Article 13 The term of validity for a Pharmaceutical Producer Licence, a Pharmaceutical Trading Enterprise Licence, or a Dispensing Permit is 5 years. If the licensee wishes to continue its production or trading or making medicament preparation upon expiration of the licence, it must reapply for permission. The entire application procedures must be repeated.

  If an enterprise has gone bankrupt or has wound up business, the license it is holding should be cancelled by the administrative department of health that has issued it.

  Article 14 Pharmaceutical Producer Licence, Pharmaceutical Trading Enterprise Licence, and Dispensing Permit shall be printed exclusively by the administrative department of health under the State Council.

  Chapter IV Examination and Approval of New Medicines

  Article 15 The state encourages research in and development of new medicines. All pharmaceutical research units, medical colleges, pharmaceutical production enterprises, medical treatment units or individuals with the necessary conditions are encouraged to engage in the research in and development of new medicines.

  Article 16 Procedures for the examination and approval of new medicines shall be formulated by the administrative department of health under the State Council.

  Article 17 Before a new medicine is put to clinical testing, the research and development unit of this medicine is required to submit an application together with the relevant data and samples in accordance with the provisions for the examination and approval of new medicines.

  Article 18 Clinical testing or clinical verification of a newly developed medicine must be conducted in the medical treatment unit(s) approved by the administrative department of health at the level of the province, autonomous region or municipality directly under the Central Government.

  Article 19 After new medicines have been clinically tested and verified and have passed the primary examination by the administrative departments of health at the level of the province, autonomous region or municipality directly under the Central Government, the research and development unit of these new medicines shall submit an application to the administrative department of health under the State Council for examination and approval and New Medicine Certificates shall be issued accordingly.

  The administrative department of health under the State Council is required to call, at the earliest possible time, the Medicine Appraisal Committee to make technical appraisal of the newly developed medicine after the complete application materials are received. A decision must be made within two months of the technical appraisal.

  Article 20 The administrative department of health under the State Council and those in the provinces, autonomous regions or municipalities directly under the Central Government may set up a Medicine Appraisal Committee which is composed of experts in medical science and pharmacology from medical treatment units, scientific research units, pharmaceutical factories and medical colleges.

  Article 21 The clinical testing or clinical verification unit, the department to examine and approve the newly developed medicine and individuals so involved are required to keep confidential the relevant data, figures, production techniques provided by a unit or individual that has developed the new medicine.

  Chapter V Registered Document of Approval for Medicines

  Article 22 For the production of a new medicine, the production unit shall submit an application to the administrative department of health under the State Council for examination and approval upon which a Registered Document of Approval shall be issued to the unit. However, this does not apply to the production of traditional Chinese medicine in ready-to-use forms.

  To produce a certain kind of medicine for which the state, the province, autonomous region or municipality directly under the Central Government has already set standards, the production unit is required to submit an application to the administrative department of health at the level of the province, autonomous region or municipality directly under the Central Government. After consulting the department in charge of the production and trading of pharmaceuticals at the same level, the administrative department of health shall make a decision on whether to issue the Registered Document of Approval to the unit. However, this does not apply to the production of traditional Chinese medicine in ready-to-use forms.

  Article 23 When applying for a Registered Document of Approval for a medicine, the production unit must present testing samples and relevant data to the medicine inspection organ appointed by the administrative department of health at the level of the province, autonomous region or municipality directly under the Central Government. The medicine inspection organ is required to make a test report and refer it to the administrative department of health for examination and approval, which shall, within 30 days of receipt of the test report, make a decision on whether to issue the Registered Document of Approval to the unit.

  Article 24 The Registered Document of Approval for a medicine is valid for 5 years, during which time no change of the registration number shall be allowed. The Registered Document of Approval of a medicine shall become invalid if the medicine has not been produced for 3 years.

  Article 25 The administrative department of health under the State Council is required to organize investigations of medicines that have been approved for production. The Medicine Appraisal shall revoke the Registered Document of Approval if it discovers by appraisal that the medicine's curative effects are uncertain, that they produce serious adverse reactions, or that for other reasons they are harmful to people's health.

  Chapter VI Administration of Pharmaceutical Production Enterprises

  Article 26 The state shall practise The Norms For Quality Control of Medicine Production. The administrative department of health under the State Council shall formulate The Norms For Quality Control of Medicine Production and supervise the implementation thereof. The departments in charge of the production and trading of medicines may formulate specific rules to guide the gradual implementation of the Norms.

  Article 27 All the newly built pharmaceutical factories and the extension or rebuilt workshops of the existing pharmaceutical factories are required to meet the requirements stipulated in the Norms For Quality Control of Medicine Production. The existing pharmaceutical enterprises are required to establish hygiene rules and regulations to ensure medicine quality and strive to meet all the requirements stipulated in the Norms For Quality Control of Medicine Production gradually and in a planned way.

  Article 28 Pharmaceutical production enterprises shall be staffed with professional technical personnel and skilled workers who must meet the following qualifications:

  (1) a factory manager in charge of pharmaceutical production and quality control must be familiar with the techniques involved in pharmaceutical production;

  (2) the post of the director in charge of pharmaceutical production technology and quality inspection shall be held respectively by a pharmaceutist, an assistant engineer or a herbdruggist, depending on the kind of medicine being produced;

  (3) the responsible workshop technician is required to have an education of at least the technical school level and with 5 years or more production experience;

  (4) the technical workers are required to go through technical training before they are allowed to operate independently;

  (5) with respect to those pharmaceutical factories processing traditional Chinese medicines into ready-to-use forms, if they are unable to meet the requirements stated in Item 2 of Article 28 of these Measures, the relevant posts shall be held by Chinese medicinal herb personnel who are familiar with the properties of the herbal medicine processed, can appraise medicinal herbs and have a mastery of the production techniques.

  These personnel must be examined by and registered with the administrative department of health above county level.

  Article 29 Pharmaceutical enterprises are required to have factory premises, facilities and a sanitary environment to ensure the quality of the medicine. They must be kept clean and tidy. If they are engaged in the preparation of transfusion medicament and powdered injection, they must have ultra clean conditions and super clean environment.

  Article 30 Pharmaceutical enterprises are required to have their own quality inspection organ and personnel, as well as necessary instrument and equipment to ensure the quality of their products.

  Article 31 Traditional Chinese medicine factories (including those traditional Chinese medicine workshops in Western medicine factories) must not only meet the requirements stipulated in Articles 28, 29, 30 and 32 of these Measures but also abide by the following stipulations:

  (1) Raw medicinal herbs must be pretreated by way of picking, sorting, washing and baking according to the relevant requirements.

  (2) See to it that the processing of traditional Chinese medicine into ready-to-use forms (including batching, grinding and packaging) shall be done in an environment free from contamination.

  (3) Traditional Chinese medicine technical personnel shall be put in charge of quality control of the Chinese medicine produced in the Western medicine factories.

  Article 32 Medicines must be made in accordance with the verified standards and through the fixed technical processes. If a pharmaceutical factory intends to make any change in the production technique which may affect the quality of the medicine, it is required to submit an application to the administrative department of health at the level of the province, autonomous region or municipality directly under the Central Government for examination and approval.

  Article 33 Pharmaceutical enterprises are required to have a complete production record and lab testing record on file. These records shall be kept for one year after the expiry date of the recorded batch of medicine. With respect to medicines without expiry dates, their records shall be kept for 3 years.

  Article 34 It is required that all raw materials and additives needed in the production of medicines, the containers and packaging material that may directly contact the medicine must meet the requirements of the state pharmacopoeia or other pharmaceutical standards. Pharmaceutical factories that plan to use other kinds of materials are required to report their plans to the administrative department of health for the record.

  Article 35 Pharmaceutical enterprises must strengthen medicine quality control. All kinds of medicines are subject to quality inspection by their own medicine inspection organs before leaving the production premises. A quality tag or lab testing report shall be put in the interior package of quality products. Those medicines that fail to pass the quality inspection shall not be allowed to leave the production premises.

  Chapter VII Administration of Pharmaceutical Trading Enterprises

  Article 36 Pharmaceutical trading enterprises shall be staffed with full time pharmaceutical technical personnel who must meet the following qualifications:

  (1) A wholesale pharmaceutical trading enterprise shall set up quality inspection organs which shall be put under the charge of professional pharmacists of Chinese or Western medicine.

  (2) A retail pharmaceutical trading enterprise shall be staffed with a pharmacist or a Chinese medicine pharmacist or a full time pharmaceutical staff worker who has been examined and registered by the administrative department of health at or above county level.

  (3) Non-pharmaceutical workers newly recruited or staffed to engage in pharmaceutical preparation, purchasing, storage keeping or marketing of medicines are required to go through professional training before they are allowed to work independently.

  Article 37 The business premises, facilities, storage facility and clean environment of a pharmaceutical trading enterprise must meet the following requirements:

  (1) The storage facilities must meet the requirements by the physical properties and chemical characters of medicines. The storage must be well equipped against dust, rats and deterioration. For those medicines which need to be kept away from light and in low temperature, there must be light lock and thermal protective storage devices.

  (2) A pharmaceutical trading enterprise that also deals in other merchandise is required to install separate counters for these merchandise. No medley of medicine and other articles in the same counter shall be allowed.

  Article 38 Pharmaceutical trading enterprises may prepare or process Chinese medicine (including slicing, roasting, baking, shimmering, etc.) or make up prescriptions for patients. However, they may not make any ready-for-use Chinese medicine for sale.

  Article 39 Pharmaceutical trading enterprises are required to establish a strict quality checking system and a storage system which includes stock checking in and out and stock protection.

  Article 40 Pharmaceutical trading enterprises must examine carefully the stock of medicine prior to its purchase. The items for examination shall include its name, producer's name, batch number, quality certificate, registered document (number) of approval, registered trade mark, packing and exterior quality. With respect to Chinese medicinal materials, it is required to examine the packing which must include its name, place of origin, name of consignor and quality inspection mark.

  Chapter VIII Administration of Medicaments Prepared by Medical Treatment Units

  Article 41 Medical treatment units that prepare their own medicaments shall meet the following requirements:

  (1) the post in charge of medicament preparation and inspection in hospitals at or above the county level (including these medical treatment units with more than 100 ward beds in factories, mines, enterprises or institutions) shall be held by a person who bears at least the title of senior pharmacist.

  Such a post in a hospital under the county level must be held by a person who bears at least the title of pharmacist.

  (2) preparation of medicaments must be made in a proper building with adequate facilities and in clean and tidy environment. Places for preparation of sterilized medicaments must have a locker room, buffer room, wash room, preparation room, filling and sealing room, sterilization room, packing room and air-conditioning. Places for preparation of infusion and transfusion medicaments are required to have super clean conditions.

  Article 42 In preparing medicaments, it is required to strictly abide by the operating rules, quality inspection rules and hygiene rules. It is required to have detailed and complete records for the preparation of each batch of medicament.

  Article 43 The medical treatment units that prepare their own medicaments are required to have appropriate medicament inspection labs.

  The medicine inspection lab shall sign and issue a quality certificate for those medicaments that have passed the inspection and may be adopted for clinical application. Rejects shall not be allowed for clinical use.

  Article 44 Medical treatment units may prepare only those medicaments that are to be used clinically or in research by themselves and that are not available on the market or insufficiently supplied. These medicaments may not go to the market or do so in a devious manner.

  Article 45 Medical treatment units are required to prepare their medicaments for clinical use in conformity with the norms for the preparation of clinical medicaments stipulated by the administrative department of health at the level of the province, autonomous region or municipality directly under the Central Government and report to the local administrative department of health for the record.

  Article 46 In medical treatment units, no divisions shall be allowed to prepare and supply clinical medicaments except the division of pharmacy and the division of radioisotope.

  Chapter IX Penalty Provisions

  Article 47 Violation of Article 15 of the Pharmaceutical Administration Law and violation of Chapter VIII of the same law related to the administration of advertisements shall have disciplinary sanctions imposed by the administration department for industry and commerce; violation of the Pharmaceutical Administration Law and these Measures shall have disciplinary sanctions imposed by the administrative department of health at or above county level with a written penalty notice. It is required to state a quality inspection result on a penalty notice for fake medicine and medicine of inferior quality. All the forfeit shall be turned in to the national treasury.

  Article 48 Those who make or sell or use fake medicine shall have their fake medicines and illegal gains confiscated. The administrative department of health shall impose a maximum fine five times or less the price of the standard medicine which the fake equivalent is used to pass off for according to the seriousness of the case.

  Article 49 Those who make or sell or use medicine of inferior quality shall have their inferior medicine and illegal gains confiscated. The administrative department of health shall impose a maximum fine three times or less the price of the standard medicine which the inferior equivalent is used to pass off for according to the seriousness of the case.

  Article 50 Any one of the following acts of making, selling or using fake or inferior medicines shall be considered as a serious case on which the administrative department of health shall impose severe disciplinary sanctions:

  1. a counterfeit of other medicine with narcotics, psychotropic substances, toxic drugs or radioactive drug or vice versa; 2. an act of making or selling fake medicine or inferior medicine to be mainly administered to babies or infants;

  3. an act of making, selling or using fake or inferior medicine which has produced harmful results as to endanger people's health;

  4. repetition of an act of making, selling or using fake or inferior medicine after being penalized;

  5. any act that shall be imposed with severe punishment as stipulated in other state laws and regulations.

  Article 51 Any units engaged in the production, trading or preparation of medicines without obtaining the Pharmaceutical Producer Licence, Pharmaceutical trading Enterprise Licence or Dispensing Permit shall be ordered to suspend production, business operations or preparation of such medicines.

  The medicines and the illegal gains therefrom shall all be confiscated and the administrative department of health may impose a maximum fine five times the price of the standard medicine or medicament, according to the seriousness of the case.

  Article 52 Units or individuals that have committed any of the following violations shall be given a disciplinary warning or penalized with a maximum fine of 20,000 RMB yuan according to the seriousness of the case:

  1. to import medicines from abroad for the first time without approval by the administrative department of health under the State Council;

  2. to import medicines from abroad without inspection by the medicine inspection organ at the border port;

  3. to conduct clinical testing or verification of new medicine without authorization;

  4. to change the technological process of production without approval by the administrative department of health and, as a result, the quality of the medicine has been degraded;

  5. to prepare medicaments for sale or for sale in devious manner by medical treatment units.

  Article 53 Any unit or individual that has committed any one of the following acts shall be given a disciplinary warning or penalized with a maximum fine of 10,000 RMB yuan according to the seriousness of the case:

  1. fail to indicate the expiry date of the medicine which ought to be indicated;

  2. violate the regulations concerning inner packaging of Chinese medicinal materials or protective packaging of pharmaceuticals for shipment;

  3. fail to label the packing as required or the items printed on the label or on the package insert are not in conformity with the requirements;

  4. to purchase or sell newly discovered Chinese medicinal materials or those introduced from abroad that have not been examined and approved.

  Article 54 Any individual at the medicine inspection organs or any medicine supervisor who abuses his power or engages in malpractices for personal gains shall be given a disciplinary sanction by the administrative department if the offence is not very serious; if the case is serious as to constitute a crime, he shall be prosecuted for criminal responsibility according to law.

  Chapter X Supplementary Provisions

  Article 55 Labels for narcotics, psychotropic substances, toxic drugs, radioactive drugs and medicines for external application shall be designed as follows(See the attached drawings [*1])。

  Article 56 The right to interpret these Measures resides in the administrative department of health

  Article 57 These Measures shall go into effect as of the date of promulgation.

  Note:

  [*1] The attached drawings see page 1505. -The Editor

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