中华人民共和国药品管理法(双语)(17)

作者:admin

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2014-3-7 14:58

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.