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中华人民共和国药品管理法           ★★★

中华人民共和国药品管理法

作者:未知 文章来源:互联网 点击数: 更新时间:2012-7-3 16:34:52

 

下载华洋英语翻译工具条2007:

 


 

LAW OF THE PEOPLE'S REPUBLIC OF CHINA ON THE ADMINISTRATION OF DRUGS

第一条为加强药品监督管理,保证药品质量,增进药品疗效,保障人民用药安全,维护人民身体健康,特制定本法。

This law has been drawn up in order to strengthen drug control and administration, ensure the quality of drugs, enhance the efficacy of drugs, guarantee safe drug use and safeguard the physical health of the people.

第二条国务院卫生行政部门主管全国药品监督管理工作。

The State Council department responsible for health administration is the body in charge of national drug control and administration.

第三条国家发展现代药和传统药,充分发挥其在预防、医疗和保健中的作用。

The State develops both modern medicines and traditional medicines, and fully utilises them in the prevention and treatment of disease, as well as in health care.

国家保护野生药材资源 鼓励培育中药材。

The State safeguards resources of uncultivated medicinal materials and encourages the cultivation of raw materials used for traditional Chinese medicines.

第二章药品生产企业的管理

CHAPTER II ADMINISTRATION OF DRUG-PRODUCING ENTERPRISES

第四条开办药品生产企业必须由所在省、自治区、直辖市药品生产经营主管部门审查同意,经所在省、自治区、直辖市卫生行政部门审核批准,并发给《药品生产企业许可证》。

The establishment of a drug-producing enterprise must be examined and agreed to by the department in charge of drug production and handling in the province, autonomous region or municipality under the direct control of the Central Government in which the enterprise is located. It shall be subject to examination and approval by the department responsible for health administration in the province, autonomous region or municipality under the direct control of the Central Government, which shall issue the "Drug-production Enterprise Licence".

无《药品生产企业许可证》的工商行政管理部门不得发给《营业执照》。

 Without a "Drug-production Enterprise Licence", the department administering industry and commerce may not issue a "Business Licence".

《药品生产企业许可证》应当规定有效期,到期重新审查发证。具体办法由国务院卫生行政部门规定。

The "Drug-production Enterprise Licence" shall stipulate its period of validity, and at the expiry of the period the issue of the licence shall be examined afresh. Specific procedures will be determined by the State Council department responsible for health administration.

第五条开办药品生产企业必须具备以下条件:

The establishment of an enterprise to produce drugs must satisfy the following conditions:

(一)具有与所生产药品相适应的药师或者助理工程师以上技术人员及技术工人。

(1) It must employ pharmacists, technical personnel above the rank of assistant engineer and technical workers appropriate to the drug production carried out by the enterprise.

中药饮片加工企业没有药师或者助理工程师以上技术人员,配备熟悉药性并经县级以上卫生行政部门审查登记的药工人员。

Where an enterprise engaged in the processing of traditional Chinese medicine does not have a pharmacist or technical personnel of a rank above that of assistant engineer, it may use drug industry personnel with an intimate knowledge of drugs who have been examined and registered by a department of health administration above the county level.

(二)具有与所生产药品相适应的厂房、设施和卫生环境。

(2) It must have a factory building, facilities and a hygienic environment appropriate to its production of drugs.

(三)具有能对所生产药品进行质量检验的机构或者人员以及必要的仪器设备。

(3) It must have an organisation or personnel capable of carrying out quality examinations on the drugs produced as well as the necessary instruments and equipment.

第六条药品必须按照工艺规程进行生产,生产记录必须完整准确。

The production of drugs must be carried out in accordance with the correct technological procedures; production records shall be kept in detail and accurately.

中药饮片的炮制必须符合《中华人民共和国药典》,或者省、自治区、直辖市卫生行政部门制定的《炮制规范》的规定。

The preparation of Chinese medicines shall be in accordance with the "Pharmacopoeia of the People's Republic of China", or in accordance with the "Preparation Standards" laid down by the department administering health in that province, autonomous region or municipality under the direct control of the Central Government.

第七条生产药品所需的原料、辅料以及直接接触药品的容器和包装材料,必须符合药用要求。

Raw materials and supplementary materials required for the production of drugs as well as containers and packing materials which come into direct contact with drugs shall meet standards required for pharmaceutical use.

第八条药品出厂前必须经过质量检验;不符合标准的,不得出厂。

Before drugs leave the factory, they must pass a quality examination. If they do not reach the required standard, they must not leave the factory.

第九条药品生产企业必须按照国务院卫生行政部门制定的《药品生产质量管理规范》的要求,制定和执行保证药品质量的规章制度和卫生要求。

Drug-producing enterprises must formulate and implement a system of rules and regulations and hygiene requirements to guarantee the quality of drugs in accordance with the requirements of the "Standards for the Administration of Drug-production Quality" laid down by the department of the State Council administering health.

第三章药品经营企业的管理

CHAPTER III ADMINISTRATION OF DRUG-HANDLING ENTERPRISES

第十条开办药品经营企业必须由所在地药品生产经营主管部门审查同意,经县级以上卫生行政部门审核批准,并发给《药品经营企业许可证》。无《药品经营企业许可证》的,工商行政管理部门不得发给《营业执照》。

The establishment of a drug-handling enterprise must be examined and agreed to by the department responsible for drug production and handling in the place where the enterprise is situated, and must be examined and approved by a health department at county level or above, which will issue a "Drug-handling Enterprise Licence", without which the department administering industry and commerce may not issue a "Business Licence".

《药品经营企业许可证》应当规定有效期,到期重新审查发证。具体办法由国务院卫生行政部门规定。

A "Drug-handling Enterprise Licence" shall stipulate its period of validity, and at the expiry of the period the issue of the licence shall be examined afresh. Specific procedures will be determined by the department of the State Council administering health.

第十一条开办药品经营企业必须具备以下条件:

The establishment of a drug-handling enterprise must satisfy the following conditions:

(一)具有与所经营药品相适应的药学技术人员。

(1) It must employ pharmaceutical technicians appropriate to the medicines handled.

经营中药的企业和兼营药品的企业没有药学技术人员.配备熟悉所经营药品的药性并经县级以上卫生行政部门审查登记的药工人员。

Where an enterprise engaged in the handling of Chinese medicines or partly engaged in handling drugs does not have a pharmaceutical technician it may use drug industry personnel with an intimate knowledge of the medicinal nature of the drugs handled who have been examined and registered by a department administering health at above county level.

(二)具有与所经营药品相适应的营业场所、设备、仓储设施和卫生环境。

(2) It must have business premises, equipment, storage facilities and a hygienic environment appropriate to the drugs handled.

第十二条收购药品,必须进行质量验收;不合格的,不得收购。

On purchasing drugs, quality examinations must be carried out; if the drugs do not come up to standard, they may not be purchased.

第十三条销**药品必须准确无误,并正确说明用法、用量和注意事项;

In selling drugs, it is necessary to be exact and accurate; the method of use, dosage and points to note must be explained precisely.

调配处方必须经过核对,对处方所列药品不得擅自更改或者代用。

In making up prescriptions, checks must be carried out; the drugs itemised in the prescription must not be altered or substituted without authorisation. 

对有配伍禁忌或者超剂量的处方应当拒绝调配;必要时经处方医生更正或者重新签字,方可调配。

Where a prescription contains ingredients that are incompatible or amounts of ingredients in excess of the proper dosage, a request to make up the prescription shall be refused; if necessary, after the prescribing doctor has corrected it and signed it again, it may be made up.

销**地道中药材,必须标明产地。

Where authentic Chinese medicines are sold, they shall be labelled to indicate the place of origin.

第十四条药品仓库必须制定和执行药品保管制度,采取必要的冷藏、防潮、防虫、防鼠等措施。

Drug warehouses shall lay down and implement a system of rules and regulations for the storage of drugs and take measures necessary in relation to cold storage, protection against damp, and protection from insects, rodents, etc.

药品入库出库必须执行检查制度。

An inspection system shall be put into effect in relation to drugs which are brought into or removed from the warehouse.

第十五条城乡集市贸易市场可以出**中药材,国家另有规定的除外。

Chinese medicinal materials may be sold in town and country trading markets except where otherwise stipulated by the State.

城乡集市贸易市场不得出**中药材以外的药品持有《药品经营企业许可证》的除外。

Drugs other than Chinese medicinal materials may not be sold in the trading markets of country towns, unless a "Drug-handling Enterprise Licence" is held.

第四章医疗单位的药剂管理

CHAPTER IV ADMINISTRATION OF DRUGS IN MEDICAL TREATMENT UNITS

第十六条医疗单位必须配备与其医疗任务相适应的药学技术人员,非药学技术人员不得直接从事药剂技术工作。

Medical treatment units must be staffed with the number of pharmaceutical technicians appropriate to their medical treatment responsibilities. Personnel who are not pharmaceutical technicians may not be engaged directly in pharmaceutical technical work.

第十七条医疗单位配制制剂必须经所在省、自治区、直辖市卫生行政部门审查批准,并发给《制剂许可证》。

The making up of drugs by medical treatment units must be examined and approved by the department in charge of health administration in the province, autonomous region or municipality under the direct control of the Central Government where the unit is situated, which will issue a "Dispensing Licence".

《制剂许可证》应当规定有效期,到期重新审查发证。具体办法由国务院卫生行政部门规定。

A "Dispensing Licence" shall stipulate its period of validity, and at the expiry of the period the issue of the licence shall be examined afresh. Specific procedures will be laid down by the department of the State Council administering health.

第十八条医疗单位配制制剂必须具有能够保证制剂质量的设施、检验仪器和卫生条件。

A medical treatment unit which makes up drugs must have adequate facilities, instruments for examination and hygienic conditions to ensure the quality of the drugs prepared.

第十九条医疗单位配制的制剂,必须根据临床需要并按照规定进行质量检验;合格的,凭医生处方使用。

The drugs made up by medical treatment units must comply with clinical requirements and, in accordance with regulations, quality examinations must be conducted. They are only to be used if up to quality and on a doctor's prescription.

医疗单位配制的制剂不得在市场销**。

Drugs made up by medical treatment units may not be sold on the market.

第二十条医疗单位购进药品,必须执行质量验收制度。

When a medical treatment unit purchases drugs, it must implement a system of checking the quality on delivery.

第五章药品的管理

CHAPTER V DRUG ADMINISTRATION

第二十一条国家鼓励研究、创制新药。

The State encourages research into and development of new drugs.

研制新药必须按照规定向国务院卫生行政部门或者省、自治区、直辖市卫生行政部门报送研制方法、质量指标、药理及毒理试验结果等有关资料和样品。经批准后,方可进行临床试验或者临床验证。

Where a new drug has been researched and developed, in accordance with the regulations, a report must be submitted, with samples, to the State Council department administering health or the department of the province, autonomous region or municipality under the direct control of the Central Government administering health, giving details of the method of research and development, quality norms, pharmacological and toxicological tests and other relevant data. Only after it has been approved may clinical tests or clinical verifications be carried out.

完成临床试验或者临床验证并通过鉴定的新药由国务院卫生行政部门批准发给****。

Where a new drug has completed its clinical tests or clinical verification and has passed an appraisal it may be approved by the department of the State Council administering health, which will issue a certificate.

第二十二条生产新药,必须经国务院卫生行政部门批准,并发给批准文号。但是,生产中药饮片除外。

The production of new drugs must be approved by the department of the State Council administering health which will issue an approval number. However, the production of Chinese medicines sliced and prepared for decoction is excepted.

生产已有国家标准或者省、自治区、直辖市标准的药品,必须经省、自治区、直辖市卫生行政部门征求同级药品生产经营主管部门意见后审核批准,并发给批准文号。但是,生产中药饮片除外。

The production of drugs for which there is already a national drug standard, or a drug standard of a province, autonomous region or municipality under the direct control of the Central Government, must be examined and approved by the department responsible for health administration in the relevant province, autonomous region or municipality under the direct control of the Central Government after seeking the opinion of the corresponding authority responsible for the drug-producing enterprise. An approval number will be issued. However, the production of Chinese medicines sliced and prepared for decoction is excepted.

第二十三条药品必须符合国家药品标准或者省、自治区、直辖市药品标准。

Drugs must comply with the national drug standard, or with the drug standard of the province, autonomous region or municipality under the direct control of the Central Government.

国务院卫生行政部门颁布的《中华人民共和国药典》和药品标准,为国家药品标准。

The "Pharmacopoeia of the People's Republic of China" and drug standards promulgated by the department of the State Council administering health are the national drug standards.

国务院卫生行政部门的药典委员会负责组织国家药品标准的制定和修订。

The Pharmacopoeia Committee of the department of the State Council administering health is the body responsible for handling the setting and revision of national drug standards.

第二十四条国务院卫生行政部门和省、自治区、直辖市卫生行政部门可以成立药品审评委员会,对新药进行审评,对已经生产的药品进行再评价。

The State Council department responsible for health administration and the departments of the provinces, autonomous regions and municipalities under the direct control of the Central Government administering health may establish a Drug Evaluation Committee to evaluate new drugs and re-evaluate drugs already being produced.

第二十五条国务院卫生行政部门对已经批准生产的药品,应当组织调查;对疗效不确、不良反应大或者其他原因危害人民健康的药品,应当撤销其批准文号。

The department of the State Council responsible for administering health shall organise investigation into drugs already approved for production; where the efficacy of a drug is not reliable, the side-effects to a drug are great, or a drug is for any other reason harmful to people's health, the approval number shall be revoked.

已被撤销批准文号的药品不得继续生产、销**;已经生产的由当地卫生行政部门监督销毁或者处理。

Where the approval number of a drug has been revoked, production and sale of the drug may not be continued; what has already been produced shall be burnt or disposed of under the supervision of the local department administering health.

第二十六条禁止进口疗效不确、不良反应大或者其他原因危害人民健康的药品。

It is forbidden to import a drug if its efficacy is not reliable, if its side-effects are great, or it is for any other reason harmful to people's health.

第二十七条首次进口的药品,进口单位必须提供该药品的说明书、质量标准、检验方法等有关资料和样品以及出口国(地区)批准生产的证明文件,经国务院卫生行政部门批准,方可签订进口合同。

Where a drug is being imported for the first time, the importing unit must submit a written description of the drug, details of its quality standards, testing and other relevant data, samples, and documentation proving that the exporting country (place) has approved production. Only when the approval of the department of the State Council administering health has been obtained may the import contract be signed.

第二十八条进口的药品,必须经国务院卫生行政部门授权的药品检验机构检验;检验合格的,方准进口。

Imported drugs must be examined by a drug examination body so authorised by the State Council department responsible for health administration. Only when a drug passes examination will importation be permitted.

医疗单位临床急需或者个人自用进口的少量药品按照海关的规定办理进口手续。

The importation of a small amount of a drug to meet the urgent clinical needs of a medical treatment unit or for the personal use of an individual is to follow the importation procedures stipulated by Customs.

第二十九条对国内供应不足的中药材、中成药,国务院卫生行政部门有权限制或者禁止出口。

Where the supply of Chinese medicinal materials or prepared Chinese medicine is not sufficient for the Chinese domestic market, the State Council department responsible for health administration has the power to restrict or prohibit its export.

第三十条进口、出口******品和国务院卫生行政部门规定范围内的精神药品,必须持有国务院卫生行政部门发给的《进口准许证》、《出口准许证》。

In order to import or export narcotic drugs or psychotropic drugs which come within the scope laid down by the department of the State Council administering health, it is necessary to hold an "Import Licence" or "Export Licence" issued by the department of the State Council administering health.

第三十一条新发现和从国外引种的药材,经省、自治区、直辖市卫生行政部门审核批准后,方可销**。

Medicinal materials which have been newly discovered or introduced from abroad may only be sold where they have been examined and approved by the department of the province, autonomous region or municipality under the direct control of the Central Government administering health.

第三十二条地区性民间习用药材的具体管理办法,由国务院卫生行政部门制定。

Detailed provisions for the administration of local customarily used folk medicines will be laid down by the State Council department responsible for health administration.

第三十三条禁止生产、销**假药。有下列情形之一的为假药:

The production and sale of spurious drugs is prohibited. A drug is spurious if any one of the following circumstances exists:

(一)药品所含成份的名称与国家药品标准或者省、自治区、直辖市药品标准规定不符合的;

(1) The names of the ingredients contained in the drug do not correspond to the national drug standard or the drug standard set by the province, autonomous region or municipality under the direct control of the Central Government;

(二)以非药品冒充药品或者以他种药品冒充此种药品

(2) A substance that is not a drug is passed off as a drug, or one sort of drug is passed off as another drug.

有下列情形之一,药品按假药处理:

A drug will be treated as a spurious drug if one of the following circumstances exists:

(一)国务院卫生行政部门规定禁止使用的;

(1) The State Council department responsible for health administration has stipulated that its use is forbidden;

(二)未取得批准文号生产的;

(2) It was produced without first obtaining an approval number;

(三)变质不能药用的;

(3) Due to deterioration, it cannot be used for medicinal purposes;

(四)被污染不能药用的。

(4) Due to contamination, it cannot be used for medicinal purposes.

第三十四条禁止生产、销**劣药。有下列情形之一的药品为劣药:

It is forbidden to produce or sell inferior drugs. A drug is inferior if one of the following circumstances exists:

(一)药品成份的含量与国家药品标准或者省、自治区、直辖市药品标准规定不符合的;

(1) The content of its ingredients does not comply with the national drug standard or the drug standard set by the province, autonomous region or municipality under the direct control of the Central Government;

(二)超过有效期的;

(2) Its period of efficacy has expired;

(三)其他不符合药品标准规定的。

(3) It fails in any other way to comply with stipulated drug standards.

第三十五条药品生产企业、药品经营企业和医疗单位直接接触药品的工作人员,必须每年进行健康检查。患有传染病或者其他可能污染药品的疾病的患者,不得从事直接接触药品的工作。

Personnel of drug-producing enterprises, drug-handling enterprises and medical treatment units who come into direct contact with drugs must undergo a medical examination annually. Persons suffering from contagious diseases or any other disease that could contaminate drugs may not engage in work involving direct contact with drugs.

第六章药品的包装和分装

CHAPTER VI THE PACKAGING AND REPACKAGING OF DRUGS

第三十六条药品包装必须适合药品质量的要求,方便储存、运输和医疗使用。规定有效期的药品,必须在包装上注明有效期。

The packaging of drugs must be appropriate to the requirements of the quality of the drug and must facilitate their storage, transportation and use. Where a period of efficacy for a drug has been fixed, the period of efficacy must be clearly indicated on the package.

发运中药材必须有包装。每件包装上必须注明品名、产地、日期、调出单位,并附有质量合格的标志。

Where Chinese medicinal materials are to be transported, they must be packaged. On each package, the name of the product, its place of origin, the date and the name of the dispatching unit must be clearly indicated and it must be marked to indicate that the quality is up to standard.

第三十七条药品包装必须按照规定贴有标签并附有说明书。

Drug packages must, in accordance with regulations, be labelled and have an instruction booklet attached.

标签或说明书上必须注明药品的品名、规格、生产企业、批准文号、产品批号、主要成份、适应症、用法、用量、禁忌、不良反应和注意事项。

The name of the drug, its specifications, the producing unit, approval number, product batch number, principal ingredients, diseases for which it is indicated, manner of use, side-effects and points to note must be clearly set out on the label or in the instruction booklet.

******品、精神药品、毒性药品、放射性药品和外用药品的标签必须印有规定标志。

The labels of narcotic drugs, psychotropic drugs, poisonous drugs, radioactive drugs and drugs for external use only must bear the prescribed mark.

第三十八条药品经营企业分装药品,必须具有与所分装药品相适应的设施和卫生条件,由药学技术人员负责,分装记录必须完整准确。

A drug-handling enterprise engaged in the repackaging of drugs must have equipment and hygienic conditions appropriate for the quantity of drugs repackaged. It must be under the charge of pharmaceutical technicians; records of the repackaging must be complete and precise.

分装药品必须附有说明书,在包装上注明品名、规格、生产企业和产品批号、分装单位和分装批号。规定有效期的药品,分装后必须注明有效期。

An instruction booklet must be attached to a repackaged drug. The product name, specifications, name of the production unit and product batch number and of the repackaging unit and repackaging batch number shall be set out clearly on the package. Where a period of efficacy has been set for the drug, when it has been repackaged, the period of efficacy must be clearly indicated.

第七章特殊管理的药品

CHAPTER VII DRUGS UNDER SPECIAL CONTROL

第三十九条国家对******品、精神药品、毒性药品、放射性药品,实行特殊的管理办法。管理办法由国务院制定。

The State imposes special controls on narcotic drugs, psychotropic drugs, poisons and radioactive drugs. The controls will be stipulated by the State Council.

第四十条******品,包括原植物,只准由国务院卫生行政部门会同有关部门指定的单位生产,并由省、自治区、直辖市卫生行政部门会同有关部门指定的单位按照规定供应。

The production of narcotic drugs, including the original plant, may only be undertaken by units appointed to do so by the department of the State Council administering health and relevant departments acting jointly, and supply may only be undertaken by units appointed by the department of the province, autonomous region or municipality under the direct control of the Central Government administering health and the relevant departments acting jointly.

第八章药品商标和广告的管理

CHAPTER VIII ADMINISTRATION OF DRUG TRADEMARKS AND ADVERTISING

第四十一条除中药材、中药饮片外,药品必须使用注册商标;未经核准注册的,不得在市场销**。

With the exception of Chinese medicinal materials and Chinese medicines sliced and prepared for decoction, drugs must use a registered trademark and may not be sold on the market until examined and approved for registration.

注册商标必须在药品的包装和标签上注明。

The registered trademark must be clearly shown on the package and label of the drug.

第四十二条药品广告必须经省、自治区、直辖市卫生行政部门审查批准;未经批准的,不得刊登、播放、散发和张贴。

An advertisement for a drug must be examined and approved by the department of the province, autonomous region or municipality under the direct control of the Central Government responsible for administering health; unless it is approved, it may not be published, broadcast, distributed or displayed on a poster.

第四十三条外国企业在我国申请办理药品广告,必须提供生产该药品的国家(地区)批准的证明文件、药品说明书和有关资料。

Where a foreign enterprise applies to advertise a drug in this country, it must submit documents proving approval of the drug from the country (or place) of its production, a written description of the drug and relevant material.

第四十四条药品广告的内容必须以国务院卫生行政部门或者省、自治区、直辖市卫生行政部门批准的说明书为准。

The contents of an advertisement for a drug must be in accordance with the explanatory booklet approved by the department of the State Council administering health or the department of the province, autonomous region or municipality under the direct control of the Central Government administering health.

第九章药品监督

CHAPTER IX DRUG CONTROL

第四十五条县级以上卫生行政部门行使药品监督职权。

Departments administering health above the county level exercise the power of supervision over drugs.

县级以上卫生行政部门,可以设置药政机构和药品检验机构。

Departments administering health at above county level may establish drug administration bodies and drug inspection bodies.

第四十六条县级以上卫生行政部门设药品监督员。药品监督员由药学技术人员担任,由同级人民政府审核发给****。

Departments administering health at above county level will appoint Drug Controllers. Drug Controllers will be appointed from those holding the position of pharmaceutical technicians; they shall be examined, and a certificate will be issued by the People's Governments at that level.

第四十七条药品监督员有权按照规定对辖区内的药品生产企业、药品经营企业和医疗单位的药品质量进行监督、检查、抽验,必要时可以按照规定抽取样品和索取有关资料,有关单位不得拒绝和隐瞒。

A Drug Controller has the power, in accordance with regulations, to control, inspect and test the quality of drugs in drug-producing enterprises, drug-handling enterprises and medical treatment units within the Controller's area of jurisdiction. If necessary, the Drug Controller may, in accordance with regulations, take samples and obtain relevant data which the relevant unit may not refuse to provide and may not conceal.

药品监督员对药品的生产企业和科研单位提供的技术资料,负责保密。

Drug Controllers are responsible for keeping the technical data provided by drug-manufacturing enterprises or scientific research units confidential.

第四十八条药品生产企业、药品经营企业和医疗单位,应当经常考察本单位所生产、经营、使用的药品的质量、疗效和不良反应。

Drug-producing enterprises, drug-handling enterprises and medical treatment units shall regularly inspect and study the quality, efficacy and side-effects of drugs produced, handled or used by them.

医疗单位发现药品中毒事故,必须及时向当地卫生行政部门报止。

If a medical treatment unit discovers a case of poisoning in relation to a drug, it must immediately report it to the department administering health in that area.

第四十九条药品生产企业和药品经营企业的药品检验机构或者人员,受当地药品检验机构的业务指导。

The drug-inspection body or personnel of a drug-producing enterprise or drug-handling enterprise will receive guidance in their professional work from the drug-inspection organ of that area.

第十章法律责任

CHAPTER X LEGAL RESPONSIBILITIES

第五十条生产、销**假药的,没收假药和违法所得,处以罚款,并可以责令该单位停产、停业整顿或者吊销《药品生产企业许可证》、《药品经营企业许可证》、《制剂许可证》。

Where spurious drugs are produced or sold, the spurious drugs and the illegally obtained income will be confiscated and a fine will be imposed. In addition, the relevant unit may be ordered to stop production or stop operations for rectification or its "Drug-production Enterprise Licence", "Drug-handling Enterprise Licence" or "Dispensing Licence" may be revoked.

对生产、销**假药,危害人民健康的个人或者单位直接责任人员,依照刑法第一百六十四条规定追究刑事责任。

In pursuance of the regulations of Article 164 of the Penal Code, criminal liability will be investigated and determined in relation to individuals or units directly involved in the production or sale of spurious drugs endangering the people's health.

第五十一条生产、销**劣药的,没收劣药和违法所得,可以并处罚款;情节严重的,并责令该单位停产、停业整顿或者吊销《药品生产企业许可证》、《药品经营企业许可证》、《制剂许可证》。

Where inferior drugs are produced or sold, the inferior drugs and the illegally obtained income will be confiscated and a fine may also be imposed; if the circumstances are serious, the relevant unit may be ordered to stop production or stop its operations and rectify itself, or its "Drug-production Enterprise Licence", "Drug-handling Enterprise Licence" or "Dispensing Licence" may be revoked.

对生产销**劣药,危害人民健康,造成严重后果的个人或单位直接责任人员,比照刑法第一百六十四条的规定追究刑事责任。

In pursuance of Article 164 of the Penal Code, criminal liability will be investigated and determined in relation to individuals or units directly involved in the production or sale of inferior drugs endangering the people's health.

第五十二条未取得《药品生产企业许可证》、《药品经营企业许可证》、《制剂许可证》生产药品、经营药品或者配制制剂的,责令该单位停产、停业或者停止配制制剂,没收全部药品和违法所得,可以并处罚款。

Where drugs are manufactured, handled or made up without a "Drug-production Enterprise Licence", Drug-handling Enterprise Licence" or "Dispensing Licence", the relevant unit will be ordered to stop production, stop operations or stop preparing medications. All of the illegally-produced drugs and the illegally-obtained income shall be confiscated and a fine may also be imposed.

第五十三条违反本法关于药品生产、药品经营的管理的其他规定的,处以警告或者罚款。

A violation of any other provision of this law in relation to the administration of drug production or handling will be punished by a caution or by a fine.

第五十四条本法规定的行政处罚,由县级以上卫生行政部门决定。违反本法第十五条规定、第八章有关广告管理的规定的行政处罚,由工商行政管理部门决定。

Any decision relating to the imposition of an administrative penalty pursuant to this law shall be made by the department administering health at above the county level. Any decision relating to the imposition of a penalty for and offence against Article 15 of this law or the provisions of Chapter VIII of this law with respect to the advertising of drugs, shall be made by the department administering industry and commerce. In relation to the penalty of ordering a drug-producing enterprise or drug-handling enterprise which is directly under the management of the Central Government or the People's Government of a province, autonomous region or municipality directly under the control of the Central Government to stop production or stop its operations for more than seven days, or of revoking its "Drug-production Enterprise Licence", or "Drug-handling Enterprise Licence", the department of the province, autonomous region or municipality under the direct control of the Central Government administering health shall submit it to the People's Government at the same level for decision.

对中央或者省、自治区、直辖市人民政府直接管辖的药品生产企业、药品经营企业处以停产、停业整顿7天以上或者吊销《药品生产企业许可证》、 《药品经营企业许可证》处罚的,由省、自治区、直辖市卫生行政部门报同级人民政府决定。对市、县或者市、县以下人民政府管辖的药品生产企业、药品经营企业处以停产,停业整顿 7天以上或者吊销《药品生产企业许可证》、《药品经营企业许可证》处罚的,由市、县人民政府卫生行政部门报同级人民政府决定。

In relation to a penalty ordering a drug-producing enterprise or drug-handling enterprise under the direct management of the People's Government at or below the city or county level to stop production or stop operations for more than seven days or of revoking its "Drug-production Enterprise Licence" or its "Drug-handling Enterprise Licence", the department of the city or county People's Government administering health shall submit the matter to the People's Government of the same level for decision.

没收的药品由卫生行政部门监督处理。

Confiscated drugs shall be disposed of under the supervision of the department responsible for health administration.

第五十五条当事人对行政处罚决定不服的,可以在接到处罚通知之日起 15 天内向人民法院起诉。

If a party objects to the decision to impose a penalty on him, he may, within 15 days from the date of receipt of notification of the penalty, bring an action in the People's Court. H

但是,对卫生行政部门作出的药品控制的决定,当事人必须立即执行。对处罚决定不履行逾期又不起诉的,由作出行政处罚决定的机关申请人民法院强制执行。

owever, in the case of a decision relating to drug control taken by the department responsible for health administration, the party shall immediately comply. Where the decision has not been complied with within the time limit and no action has been brought, the People's Court shall compulsorily enforce compliance upon application by the organ which made the decision.

第五十六条违反本法,造成药品中毒事故的,致害单位或者个人应当负损害赔偿责任。受害人可以请求县级以上卫生行政部门处理;当事人不服的,可以向人民法院起诉。受害人也可以直接向人民法院起诉。

In case of drug poisoning caused by a breach of this law, the unit or person who caused it shall be liable to pay compensation. The person suffering harm may request a department administering health at above county level to handle the matter; if the party who caused the harm objects, he or it may bring an action in the People's Court. The person suffering harm may also sue directly in the People's Court.

损害赔偿要求,应当从受害人或者其代理人知道或者应当知道之日起 1年内提出;超过期限的,不予受理。

A demand to be compensated for damage shall be submitted within a period of one year from the date on which the victim or his representative became aware or ought to have become aware of it. When this period has expired, the claim will not be entertained.

第五十七条本法下列用语的含义是:

The expressions used in this law are defined as follows:

药品:指用于预防、治疗、诊断人的疾病,有目的地调节人的生理机能并规定有适应症、用法和用量的物质,

"Drug" refers to a substance used for the prevention, treatment and diagnosis of human diseases, and with the object of regulating human physiological functions, with stipulated indications, usage and dosage.

包括中药材、中药饮片、中成药、化学原料药及其制剂、抗生素、生化药品、放射性药品、血清疫苗、血液制品和诊断药品等。

It includes Chinese medicinal materials and Chinese medicines sliced and prepared for decoction, prepared Chinese medicines, chemical raw material drugs and their components, antibiotics, biochemical drugs, radioactive drugs, blood serums and vaccines, blood products, diagnostic drugs and so on.

新药指我国未生产过的药品。

"New drugs" refers to those drugs which have never been produced in this country.

辅料指生产药品和调配处方时所用的赋形剂和附加剂。

"Supplementary materials" refers to excipients and additives used in the production and making up of drugs.

药品生产企业指生产药品的专营企业或者兼营企业。

"Drug-producing enterprise" refers to those enterprises exclusively or partially engaged in the production of drugs.

药品经营企业指经营药品的专营企业或者兼营企业。

"Drug-handling enterprise" refers to those enterprises exclusively or partially engaged in the handling of drugs.

第五十八条本法所说的药品生产,不包括中药材的种植、采集和饲养。

The production of drugs referred to in this law does not include the cultivation and collection of raw materials for Chinese medicines or the raising of animals in relation to Chinese medicines.

第五十九条国务院卫生行政部门根据本法制定实施办法报国务院批准施行。

Measures for the implementation of this law will be set down by the State Council department responsible for health administration and submitted to the State Council for approval and implementation.

中国人民解放军特需药品的管理办法由国家军事主管部门制定。

Special provisions for the management of drugs in the People's Liberation Army will be laid down by the department in charge of national military affairs.

第六十条本法自一九八五年七月一日起施行。

This law shall come into force on July 1, 1985.

 

 

 

 

中华人民共和国药品管理法

The Pharmaceutical Administration Law of the People's Republic of China

第一章

Chapter I General Provisions

第一条 为加强药品监督管理,保证药品质量,保障人体用药安全,维护人民身体健康和用药的合法权益,特制定本法。

Article 1 This law is formulated to enhance the supervision and control of pharmaceuticals, ensure their quality, guarantee safety in medication, and safeguard the health and legal rights and interests of the people.

第二条 在中华人民共和国境内从事药品的研制、生产、经营、使用和监督管理的单位或者个人,必须遵守本法。

Article 2 The law shall be applicable to any units or individuals engaged in research, production, trade, use, supervision and management of pharmaceuticals within the territory of the People's Republic of China.

第三条 国家发展现代药和传统药,充分发挥其在预防、医疗和保健中的作用。

Article 3 The State shall develop both modern and traditional medicines encourage their role in the prevention and treatment of diseases and in health care.

国家保护野生药材资源,鼓励培育中药材。

The State shall protect the resources of wild medicinal resources and encourage the domestic cultivation of Chinese traditional medicinal crops.

第四条 国家鼓励研究和创制新药,保护公民、法人和其他组织研究、开发新药的合法权益。

Article 4 The State shall encourage the research and production of new medicine and protect the legal rights and interests of its citizens, natural persons and other organizations in the research and development of new medicine.

第五条 国务院药品监督管理部门主管全国药品监督管理工作。国务院有关部门在各自的职责范围内负责与药品有关的监督管理工作。

Article 5 The pharmaceuticals supervisory and administrative departments under the State Council shall be responsible for the supervision and control of pharmaceuticals throughout the country. Other relevant departments under the State Council shall be responsible for the supervision and control of pharmaceuticals related to the scope of their functions.

省、自治区、直辖市人民政府药品监督管理部门负责本行政区域内的药品监督管理工作。省、自治区、直辖市人民政府有关部门在各自的职责范围内负责与药品有关的监督管理工作。

The pharmaceutical supervisory and administrative departments of the provinces, autonomous regions and municipalities directly under the central government shall be responsible for the supervision and control of pharmaceuticals within their administrative regions. Other relevant departments of the provinces, autonomous regions and municipalities directly under the central government shall be responsible for the supervision and control of pharmaceuticals related to the scope of their functions.

国务院药品监督管理部门应当配合国务院经济综合主管部门,执行国家制定的药品行业发展规划和产业政策。

The pharmaceutical supervisory and administrative departments under the State Council shall cooperate with the general administrative department of the economy under the State Council to carry out pharmaceutical development plans and industrial policies formulated by the State.

第六条 药品监督管理部门设置或者确定的药品检验机构,承担依法实施药品审批和药品质量监督检查所需的药品检验工作。

Article 6 The pharmaceutical inspection institutions established or approved by the pharmaceutical supervisory and administrative departments shall be charged with the work of pharmaceutical examination and approval, as well as quality inspection, in accordance with laws and regulations.

 第二章 药品生产企业管理

Chapter II Administration of Pharmaceutical Producing Enterprises

 第七条 开办药品生产企业,须经企业所在地省、自治区、直辖市人民政府药品监督管理部门批准并发给《药品生产许可证》,

Article 7 The establishment of a pharmaceutical producing enterprise must be approved by and issued a Pharmaceutical Production License by the pharmaceutical supervisory and administrative department of the province, autonomous region, or municipality directly under the Central government in which the enterprise is located.

凭《药品生产许可证》到工商行政管理部门办理登记注册。无《药品生产许可证》的,不得生产药品。

The establishment shall be registered at the industry and commerce administrative department based on the Pharmaceutical Production License, without which no pharmaceuticals shall be produced.

《药品生产许可证》应当标明有效期和生产范围,到期重新审查发证。

The Pharmaceutical Production License shall bear the scope of production and a period of validity, and upon expiration a new license shall be issued after examination for its renewal.

药品监督管理部门批准开办药品生产企业,除依据本法第八条规定的条件外,还应当符合国家制定的药品行业发展规划和产业政策,防止重复建设。

The approval of the establishment of pharmaceutical producing enterprises by the pharmaceutical supervisory and administrative departments shall be in conformity with Article 8 of this law, as well as the pharmaceutical development plan and the industrial policies formulated by the State to avoid the instance of a repeat establishment.

第八条 开办药品生产企业,必须具备以下条件:

Article 8 To establish a pharmaceutical producing enterprise, the following requirements must be met:

(一)具有依法经过资格认定的药学技术人员、工程技术人员及相应的技术工人;

 (1) It shall be staffed with legally certified pharmaceutical technical personnel, engineering technical personnel, as well as corresponding skilled workers.

(二)具有与其药品生产相适应的厂房、设施和卫生环境;

 (2) It shall have factory premises, facilities and a sanitary environment suitable for the medicines produced.

(三)具有能对所生产药品进行质量管理和质量检验的机构、人员以及必要的仪器设备;

 (3) It shall have a unit or competent personnel capable of inspecting the quality of the medicines produced, as well as necessary instruments and equipment.

(四)具有保证药品质量的规章制度。

 (4) It shall have rules and regulations to ensure the quality of medicines.

第九条 药品生产企业必须按照国务院药品监督管理部门依据本法制定的《药品生产质量管理规范》组织生产。药品监督管理部门按照规定对药品生产企业是否符合《药品生产质量管理规范》的要求进行认证;对认证合格的,发给认证****。

Article 9 Pharmaceutical producing enterprises must organize production in accordance with the "Standards for Quality Control of Pharmaceutical Production" formulated by the pharmaceutical supervisory and administrative departments under the State Council on the basis of this Law. Pharmaceutical supervisory and administrative departments shall confirm whether the pharmaceutical producing enterprises have met the requirements of the "Standards," and shall issue certificates to those qualified ones.

《药品生产质量管理规范》的具体实施办法、实施步骤由国务院药品监督管理部门规定。

The detailed implementation measures and implementation process of the "Standards for Quality Control of Pharmaceutical Production" shall be formulated by the pharmaceutical supervisory and administrative department under the State Council.

第十条 除中药饮片的炮制外,药品必须按照国家药品标准和国务院药品监督管理部门批准的生产工艺进行生产,生产记录必须完整准确。药品生产企业改变影响药品质量的生产工艺的,必须报原批准部门审核批准。

Article 10 Except in the preparation of traditional Chinese medicines into ready-to-use forms, pharmaceuticals must be produced in accordance with the national pharmaceutical standard and the technological procedures approved by the supervisory and administrative departments of pharmaceuticals under the State Council, and the record of production must be complete and accurate. The changes of technological procedure made by the pharmaceutical producing enterprises which affect the quality of the pharmaceuticals shall be examined and approved by the original approval authorities.

中药饮片必须按照国家药品标准炮制;国家药品标准没有规定的,必须按照省、自治区、直辖市人民政府药品监督管理部门制定的炮制规范炮制。省、自治区、直辖市人民政府药品监督管理部门制定的炮制规范应当报国务院药品监督管理部门备案。

The process for preparing traditional Chinese medicines into ready-to-use forms must conform to the national pharmaceutical standards, and in the absence of such standards, the process must conform to the processing standards stipulated by the supervisory and administrative departments of pharmaceuticals of the provinces, autonomous regions, or municipalities directly under the central government. The processing standards stipulated by the supervisory and administrative departments of pharmaceuticals of the provinces, autonomous regions, or municipalities directly under the central governments shall be placed on record at the pharmaceutical supervisory and administrative department under the State Council.

第十一条 生产药品所需的原料、辅料,必须符合药用要求。

Article 11 The raw and supplementary materials used for the production of pharmaceuticals must conform to the requirements for medicinal use.

第十二条 药品生产企业必须对其生产的药品进行质量检验;不符合国家药品标准或者不按照省、自治区、直辖市人民政府药品监督管理部门制定的中药饮片炮制规范炮制的,不得出厂。

Article 12 The pharmaceutical producing enterprises must conduct quality inspections on the pharmaceuticals they produce; products which do not meet national pharmaceutical standards or are not prepared in conformity with the processing standards stipulated by the pharmaceutical supervisory and administrative departments of the provinces, autonomous regions, or municipalities directly under the central government shall not leave the factory.

第十三条 经国务院药品监督管理部门或者国务院药品监督管理部门授权的省、自治区、直辖市人民政府药品监督管理部门批准,药品生产企业可以接受委托生产药品。

Article 13 Pharmaceutical producing enterprises can accept the authorization to produce pharmaceuticals after they obtain approval from the pharmaceutical supervisory and administrative department under the State Council or the pharmaceutical supervisory and administrative departments of the provinces, autonomous regions, or municipalities directly under the central government authorized by the supervisory and administrative department of pharmaceuticals under the State Council.

 第三章 药品经营企业管理

Chapter III Administration of Pharmaceutical Trading Enterprises

 第十四条 开办药品批发企业,须经企业所在地省、自治区、直辖市人民政府药品监督管理部门批准并发给《药品经营许可证》;

Article 14 The establishment of pharmaceutical wholesale enterprises must be sanctioned by the competent local authorities of the production and trade of pharmaceuticals of the provinces, autonomous regions or municipalities directly under the central government, which will issue a Pharmaceutical Trade License.

开办药品零**企业,须经企业所在地县级以上地方药品监督管理部门批准并发给《药品经营许可证》,凭《药品经营许可证》到工商行政管理部门办理登记注册。无《药品经营许可证》的,不得经营药品。

The establishment of pharmaceutical retail enterprises must be sanctioned by local authorities for the supervision and control of pharmaceuticals at or above the county level, which will issue a Pharmaceutical Trade License, on the basis of which registration at the industry and commerce administrative departments shall be conducted. Without the Pharmaceutical Trade License, any enterprises shall not engage in the trade of pharmaceuticals.

《药品经营许可证》应当标明有效期和经营范围,到期重新审查发证。

A Pharmaceutical Trade License shall bear a scope of trade and a period of validity, and upon expiration a new license shall be issued after examination for its renewal.

药品监督管理部门批准开办药品经营企业,除依据本法第十五条规定的条件外,还应当遵循合理布局和方便群众购药的原则。

The approval of the establishment of pharmaceutical trading enterprises by the pharmaceutical supervisory and administrative departments shall adhere to the principle of reasonable positioning and convenience for buying of pharmaceuticals, and in addition must conform to Article 15 of this Law.

第十五条 开办药品经营企业必须具备以下条件:

Article 15 To establish a pharmaceutical trading enterprise, the following requirements must be met

(一)具有依法经过资格认定的药学技术人员;

 (1) 1 It shall be staffed with legally certified pharmaceutical technical personnel.

(二)具有与所经营药品相适应的营业场所、设备、仓储设施、卫生环境;

 (2) It shall have business premises, equipment, storage facilities and a sanitary environment suitable for the pharmaceuticals in which it trades.

(三)具有与所经营药品相适应的质量管理机构或者人员;

 (3) It shall have a quality control organ or personnel suitable for the pharmaceuticals in which it trades.

(四)具有保证所经营药品质量的规章制度。

 (4) It shall have rules and regulations to ensure the quality of the pharmaceuticals in which it trades.

第十六条 药品经营企业必须按照国务院药品监督管理部门依据本法制定的《药品经营质量管理规范》经营药品。

Article 16 Pharmaceutical producing enterprises must trade in pharmaceuticals in accordance with the "Standards for Quality Control of Pharmaceutical Trading" stipulated by the pharmaceutical supervisory and administrative departments under the State Council on the basis of this Law.

药品监督管理部门按照规定对药品经营企业是否符合《药品经营质量管理规范》的要求进行认证;对认证合格的,发给认证****。

Pharmaceutical supervisory and administrative departments shall certify whether pharmaceutical trading enterprises meet the requirements of the "Standards for Quality Control of Pharmaceutical Trading" in accordance with relevant regulations, and issue certifications to qualified enterprises.

《药品经营质量管理规范》的具体实施办法、实施步骤由国务院药品监督管理部门规定。

Detailed implementation measures and procedures for the "Standards for Quality Control of Pharmaceutical Trading" shall be stipulated by the pharmaceutical supervisory and administrative departments under the State Council.

第十七条 药品经营企业购进药品,必须建立并执行进货检查验收制度,验明药品合格证明和其他标识;不符合规定要求的,不得购进。

Article 17 Pharmaceutical trading enterprises must formulate and implement check and approval rules for the purchase of pharmaceuticals, and check pharmaceutical certifications and other marks while purchasing pharmaceuticals. Pharmaceuticals that do not meet the required standards must not be purchased.

第十八条 药品经营企业购销药品,必须有真实完整的购销记录。购销记录必须注明药品的通用名称、剂型、规格、批号、有效期、生产厂商、购(销)货单位、购(销)货数量、购销价格、购(销)货日期及国务院药品监督管理部门规定的其他内容。

Article 18 Pharmaceutical trading enterprises shall keep accurate and complete records of purchased pharmaceuticals. Purchasing records must bear information on the pharmaceutical product's generic names, types, specifications, batches, valid periods, producing enterprises, purchasing (selling) units, purchasing (selling) quantity, purchasing and selling price, purchasing (selling) date and other contents required by the pharmaceutical supervisory and administrative department under the State Council.

第十九条 药品经营企业销**药品必须准确无误,并正确说明用法、用量和注意事项;调配处方必须经过核对,对处方所列药品不得擅自更改或者代用。对有配伍禁忌或者超剂量的处方,应当拒绝调配;必要时,经处方医师更正或者重新签字,方可调配。

Article 19 It is imperative for pharmaceutical trading enterprises, in the sale of pharmaceuticals, to be accurate and free of mistakes, and to provide correct directions for use, dosage and precautions. Prescriptions being dispensed must be checked. Pharmaceutical products listed in the prescription must not be presumptuously changed or substituted. Prescriptions containing incompatible substances or excessive dosages shall be rejected by the dispensary. If necessary, such prescriptions can be dispensed after they have been corrected or re-signed by the doctors who wrote them.

药品经营企业销**中药材,必须标明产地。

When traditional Chinese medicinal materials are offered for sale by pharmaceutical trading enterprises, their origin must be indicated.

第二十条 药品经营企业必须制定和执行药品保管制度,采取必要的冷藏、防冻、防潮、防虫、防鼠等措施,保证药品质量。

Article 20 Rules for storage of pharmaceuticals shall be formulated and implemented by pharmaceutical trading enterprises, which must adopt necessary measures to facilitate cold storage and protection against freezing, moisture, insects and rodents to ensure pharmaceutical quality.

药品入库和出库必须执行检查制度。

An inspection system shall be carried out for pharmaceuticals entering or leaving a warehouse

第二十一条 城乡集市贸易市场可以出**中药材,国务院另有规定的除外。

Article 21 Unless otherwise stipulated by the State, traditional Chinese medicinal materials may be marketed at urban or rural fairs.

城乡集市贸易市场不得出**中药材以外的药品,但持有《药品经营许可证》的药品零**企业在规定的范围内可以在城乡集市贸易市场设点出**中药材以外的药品。具体办法由国务院规定。

Pharmaceuticals other than traditional Chinese medicinal materials may not be sold at urban or rural fairs, but those retail enterprises which have the Pharmaceutical Trade License may set up stalls at urban or rural fairs to sell pharmaceuticals other than traditional Chinese medicinal materials within prescribed areas. Detailed measures shall be stipulated by the State Council.

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