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Taking the medical particularity into consideration, the author penetrates into the factors to judge the drug instruction defects and some matters for attention while cognising the drug instruction defects, in order to help drug manufacturers, drug operators, physicians and apothecaries to standardize their products and medical service.

根据产品责任法理论阐述了药品缺陷的含义以及我国对药品说明的有关规定;并根据药品的特殊性,深入分析了药品说明缺陷的判断因素,以及认定药品说明缺陷应注意的问题,有助于药品生产者、经营者、医师、药师等在产品和医疗服务中规范行事。