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中华人民共和国药品管理法(双语)(10)

2014-03-03    来源:网络    【      美国外教 在线口语培训

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。
[Article 24] 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。
[Article 25] 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、销售;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Where the approval number of a drug has been revoked, production and sale of the drug may not be continued; what has already been produced shall be burnt or disposed of under the supervision of the local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。
[Article 26] 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。
[Article 27] 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。
[Article 28] 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.



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