中华人民共和国药品管理法(双语)(14)

作者:admin

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2014-3-5 09:19

第六章药品的包装和分装
CHAPTER VI THE PACKAGING AND REPACKAGING OF DRUGS

第三十六条药品包装必须适合药品质量的要求,方便储存、运输和医疗使用。规定有效期的药品,必须在包装上注明有效期。
[Article 36] The packaging of drugs must be appropriate to the requirements of the quality of the drug and must facilitate their storage, transportation and use. Where a period of efficacy for a drug has been fixed, the period of efficacy must be clearly indicated on the package.

发运中药材必须有包装。每件包装上必须注明品名、产地、日期、调出单位,并附有质量合格的标志。
Where Chinese medicinal materials are to be transported, they must be packaged. On each package, the name of the product, its place of origin, the date and the name of the dispatching unit must be clearly indicated and it must be marked to indicate that the quality is up to standard.

第三十七条药品包装必须按照规定贴有标签并附有说明书。
[Article 37] Drug packages must, in accordance with regulations, be labelled and have an instruction booklet attached.

标签或说明书上必须注明药品的品名、规格、生产企业、批准文号、产品批号、主要成份、适应症、用法、用量、禁忌、不良反应和注意事项。
The name of the drug, its specifications, the producing unit, approval number, product batch number, principal ingredients, diseases for which it is indicated, manner of use, side-effects and points to note must be clearly set out on the label or in the instruction booklet.