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西藏藥業(600211.SH):將盡快將依姆多上市許可持有人由阿斯利康變更至公司或子公司
格隆匯 02-02 17:23

格隆匯 2 月 2日丨西藏藥業(600211.SH)公佈,目前鑑於根據《中華人民共和國藥品管理法(2019年修訂)》、《藥品註冊管理辦法》、《藥品生產監督管理辦法》和《藥品上市後變更管理辦法(試行)》等相關規定,從藥政層面藥品上市許可持有人主體可直接變更,藥品上市許可持證與藥品生產可分離。因此,依姆在國內的上市許可直接辦理到本公司或子公司名下為此湖南康哲國家藥品監督管理局提交了關於撤回依姆多技術轉移申請的報吿並得到批准:同意依姆多產品註冊申請的撤回,終止註冊程序(通知書編號:2021L050492021L05050)

公司將依據相關法規儘快將依姆多上市許可持有人由阿斯利康變更至公司或子公司繼續按照約定委託阿斯利康湖南康哲作為受託生產廠生產依姆多產品

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