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2013年11月20日,国家食品药品监督管理总局办公厅发布通知,要求各省、自治区、直辖市食品药品监督管理局根据其监测评价结果,对含左旋延胡索乙素药品处方药说明书和非处方药说明书范本进行修订,同时要求通知行政区域内相关药品生产企业做好以下工作:一、在2013年12月30日前,依据《药品注册管理办法》等有关规定提出修订说明书的补充申请备案。说明书的其他内容应当与原批准内容一致。补充申请备案之日起生产的药品,不得继续使用原药品说明书。二、应当将说明书修订的内容及时通知相关医疗机构、药
On November 20, 2013, the General Office of the State Food and Drug Administration issued a circular calling on the Food and Drug Administration of provinces, autonomous regions and municipalities directly under the Central Government to revise the specifications of prescriptions and over-the-counter prescriptions for drugs containing levonorgestrel based on their monitoring and evaluation results At the same time, it is required to notify the relevant pharmaceutical manufacturers in the administrative region to do the following work: 1. Before December 30, 2013, they filed the supplementary application for the record according to the relevant provisions of the “Measures for the Administration of Drug Registration”. Other contents of the manual should be consistent with the original approval. Supplementary application for the record of the production of drugs, shall not continue to use the original drug instructions. Second, the contents of the manual should be promptly notified to the relevant medical institutions, medicine