Regulation for Drug Shortage Management Article 11
In case any of the following situations is met, the Central Competent Health Authority may revoke or repeal the special case approval given to the essential drug or its substitute drug, and order the pharmaceutical firm in question to recall the drug within a time limit:1.The application documents are found to contain false information.2.The drug’s quality, safety or efficacy is in doubt.3.Violation of the preceding content or supplementary provisions of the special case approval.
中文原文 必要藥品短缺通報登錄及專案核准製造輸入辦法第11條
有下列情形之一者，中央衛生主管機關得撤銷或廢止必要藥品或其替代藥品之專案核准，並得令藥商限期回收：
一、申請之文件、資料有虛偽不實。
二、有品質、安全或效能之疑慮。
三、違反前條專案核准之內容或附款事項。
一、申請之文件、資料有虛偽不實。
二、有品質、安全或效能之疑慮。
三、違反前條專案核准之內容或附款事項。