摘要
目的:针对非处方药药品说明书【用法用量】项下的部分问题进行分析研究,探讨警示缺陷相关责任主体及各自应该承担的法律责任。方法:采用文献研究、数据统计和案例分析方法,首先提出非处方药品说明书在用法、用量、疗程中存在的部分问题,随后分析警示缺陷相关责任主体:药品生产企业、药品销售者、医疗机构及国家相关行政机关各自的法律责任。结果与结论:提出对【用法用量】项的内容不作限制性规定,依药品生产者根据研发药物当时的实际科学技术研究所得信息为准,促进药物研究人员对药物的不断研发和改进,为患者提供更安全、可靠、有效的药品。
Objective: To analyze and research some problems of item [usage and dosage] in non prescription drug instruction, and probe into warning defect related main responsibility body and respectively legal responsibility they shall bear. Method:Literature research, data statistics, and case analysis were applied. Firstly, some problems existing in usage, dosage and course of treatment in non prescription drug instruction were put forward. Subsequently, respective legal responsibility of warning defect related main responsibility body were analyzed including drug manufacturing enterprise, drug dealers, medical institution and national administrative agencies. Result & Conclusion: It is suggested that item [usage and dosage] content should not be restrictively provided. It should be based on the information gained when drug producer research and develop medicine according to actual science and technology at that time to promote drug research and development and improvement ceaselessly , and provide more secure, reliable, effective drugs for patients.
出处
《中药与临床》
2013年第1期53-57,63,共6页
Pharmacy and Clinics of Chinese Materia Medica
关键词
药品说明书
警示侵权
责任主体
Drug instruction
warning defect
main responsibility
