中国医疗行业法律法规中英数据库
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 develops both modern medicines and traditional medicines, and fully utilises them in the prevention and treatment of disease, as well as in health care.第四十条麻醉药品，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。 [Article 40] 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，不得在市场销售。 [Article 41] 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.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。 [Article 42] 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under the direct control of the Central Government responsible for administering health; unless it is approved, it may not be published, broadcast, distributed or displayed on a poster.第四十三条外国企业在我国申请办理药品广告，必须提供生产该药品的国家（地区）批准的证明文件、药品说明书和有关资料。 [Article 43] Where a foreign enterprise applies to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。 [Article 44] 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.第四十五条县级以上卫生行政部门行使药品监督职权。 [Article 45] Departments administering health above the county level exercise the power of supervision over drugs.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证书。 [Article 46] 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。 [Article 47] 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.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。 [Article 48] 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.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。 [Article 49] 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》。 [Article 4] 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"".第五十条生产、销售假药的，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》。 [Article 50] 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.第五十一条生产、销售劣药的，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》。 [Article 51] 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.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。 [Article 52] 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。 [Article 53] 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。 [Article 54] 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.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。 [Article 55] 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。 [Article 56] 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.第五十七条本法下列用语的含义是： [Article 57] The expressions used in this law are defined as follows: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。 [Article 58] 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。 [Article 59] 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.第五条开办药品生产企业必须具备以下条件： [Article 5] The establishment of an enterprise to produce drugs must satisfy the following conditions:第六十条本法自一九八五年七月一日起施行。 [Article 60] This law shall come into force on July 1, 1985.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。 [Article 6] The production of drugs must be carried out in accordance with the correct technological procedures; production records shall be kept in detail and accurately.
