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.

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。

[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under the direct control of the Central Government responsible for administering health; unless it is approved, it may not be published, broadcast, distributed or displayed on a poster.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。

[Article 45] 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.

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。

[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.

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。

[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.

第十章法律责任

CHAPTER X LEGAL RESPONSIBILITIES

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.

对生产、销售假药，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.

对生产销售劣药，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。

[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

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