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为保障公众用药安全,根据国家食品药品监督管理总局食药监办药化管〔2013〕110号文件,国家食品药品监督管理总局办公厅于2013年11月12日发布通知,要求各省、自治区、直辖市食品药品监督管理局对消炎利胆片说明书“不良反应”“注意事项”两项内容进行修订。(一)在2014年1月15日前,依据《药品注册管理办法》等有关规定提出修订说明书“不良反应”“注意事项”两项的补充申请报备案。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。
In order to ensure the safety of public use of drugs, according to the Document No. 110 of Drug Administration of Food and Drug Administration of the State Food and Drug Administration, the General Office of the State Food and Drug Administration issued a circular on November 12, 2013 requiring all provinces, autonomous regions, Municipality directly under the Central Government Food and Drug Administration on the instructions of anti-inflammatory gallbladder tablets “adverse reactions ” “precautions ” two content revision. (I) Prior to January 15, 2014, a supplementary application for revising the statement of “Adverse Reactions” and “Precautions” shall be submitted 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.