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| 药品说明书的定性及说明书之外用法的合法性 | |
| 引用本文： | 李浩娜,黄虎,马承严,张正光.药品说明书的定性及说明书之外用法的合法性[J].中国药事,2011,25(11):1107-1108. |
| 作者姓名： | 李浩娜 黄虎 马承严 张正光 |
| 作者单位： | 1. 山东中医药大学,济南 250355;中国药学会医药政策研究中心 2. 山东中医药大学,济南,250355 3. 中国药学会医药政策研究中心 |
| 摘 要： | 目的搞清药品说明书的法律定性及说明书之外用法的合法性。方法对相关法律规章进行分析。结果与结论我国相关规章对药品说明书的规定存在矛盾,致使实践中说明书之外用法的合法性问题不明确。应通过立法明确药品说明书的法律定性,借鉴美国经验解决说明书之外用法的合法性及规制问题。 |
| 关 键 词： | 药品说明书 说明书之外的用法 合法性 |
The Legal Status of Drug Inserts and Validity of Usage beyond Drug Inserts |
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| Li Haona,Huang Hu,Ma Chengyan,Zhang Zhengguang.The Legal Status of Drug Inserts and Validity of Usage beyond Drug Inserts[J].Chinese Pharmaceutical Affairs,2011,25(11):1107-1108. | |
| Authors: | Li Haona Huang Hu Ma Chengyan Zhang Zhengguang |
| Institution: | Li Haona1,2,Huang Hu1,Ma Chengyan1* and Zhang Zhengguang2(1Shangdong University of Traditional Chinese Medicine,Jinan 250355,2Research Center on Medicinal Policy under Chinese Pharmaceutical Association) |
| Abstract: | Objective To find out the legal nature of drug inserts and the validity of usage beyond drug inserts.Methods Come to the conclusion by analyzing the related regulations.Results and Conclusion There are self-contradictions on legal nature of drug inserts in related regulations.This makes it difficult to decide the validity of usage beyond drug inserts.The legislation should clarify the legal nature of drug inserts.We should make reference to the practice in the U.S.and find ways to settle the problem of the ... |
| Keywords: | drug inserts usage beyond drug inserts legal validity |
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