网站公告列表     无忧教育最新改版成功!  [51education  2008年5月21日]        
加入收藏
设为首页
联系站长

您现在的位置: 无忧英语教育网 >> 英语学习中心 >> 英语知识 >> 英语翻译 >> 正文
 
英汉对照法律资源--中华人民共和国药品管理法          【字体:
 

英汉对照法律资源--中华人民共和国药品管理法

作者:无忧教育    文章来源:51education.net    点击数:    更新时间:2008-5-18     


[Article 60] 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 me

上一页  [1] [2] [3] [4] [5] [6] [7] [8] [9] 下一页

实践证明经常访问无忧英语教育网 www.51education.net ,能迅速提高你的英语学习能力!积沙成塔,不断提高! 本站所提供的所有信息仅供学校课堂教学及英语学习者学习研究之用,其著作权归原作者及媒体所有。

文章录入:soosun    责任编辑:soosun 

  • 上一篇文章:

  • 下一篇文章:
  • 发表评论】【加入收藏】【告诉好友】【打印此文】【关闭窗口
    最新热点 最新推荐 相关文章
    英汉对照法律资源--中华人民…
    英汉对照法律资源--中华人民…
    英汉对照法律资源--中华人民…
    英汉对照法律资源--中华人民…
    英汉对照法律资源--中华人民…
    英汉对照法律资源--中华人民…
    英汉对照法律资源--中华人民…
    英汉对照法律资源--中华人民…
    英汉对照法律资源--中华人民…
    英汉对照法律资源--中华人民…
      网友评论:(只显示最新10条。评论内容只代表网友观点,与本站立场无关!)
     www.51education.net 无忧英语教育网 提供英语学习动力 版权所有 2006-2011 站长:无忧
    浙ICP备05019856号