Regulations Governing Management of Infectious Biological Materials Article 23
A newly established high-containment laboratory or controlled premises may be inaugurated only after being reviewed and approved by the entity’s IBC and obtaining approval from the central competent authority by submitting an application along with relevant documents and information; the same shall apply to change of its location, address or scope of operating area.When a high-containment laboratory or controlled premises falls under any of the following circumstances, the central competent authority may revoke or rescind its approval:1. The document or information submitted for approval contain false or misleading representations.2. The high-containment laboratory has ceased operation for more than one year.3. The controlled premises have not possessed, stored, used, disposed of, imported or exported BSAT for more than one year.4. The approval of the BSO, IBC or BSAT officer of the entity to which the laboratory or controlled premises belongs has been cancelled, revoked, or rescinded.5. The entity to which the laboratory or controlled premises belongs has been merged downsized, dissolved, or ceased business, or its establishment or registration permit has been revoked or rescinded.6. The laboratory or controlled premises does not store, use or dispose of any infectious biological materials.
中文原文 感染性生物材料管理辦法第23條
新設立之高防護實驗室、管制作業場所，應經設置單位生安會審議通過，並檢具相關文件、資料，向中央主管機關申請核准後，始得啟用；其位置、地址或作業區域範圍有異動時，亦同。
高防護實驗室、管制作業場所有下列情形之一者，中央主管機關得撤銷或廢止其核准：
一、申請核准之文件、資料虛偽不實。
二、高防護實驗室停止運作期間已逾一年。
三、管制作業場所無持有、保存、使用、處分及輸出入管制性生物材料已逾一年。
四、其隸屬之設置單位已註銷、撤銷或廢止其核定之生安主管、生安會或管制性生物材料主管。
五、其隸屬之設置單位已合併、裁撤、解散、歇業，或設立、登記許可已撤銷、廢止。
六、未保存、使用及處分感染性生物材料。
高防護實驗室、管制作業場所有下列情形之一者，中央主管機關得撤銷或廢止其核准：
一、申請核准之文件、資料虛偽不實。
二、高防護實驗室停止運作期間已逾一年。
三、管制作業場所無持有、保存、使用、處分及輸出入管制性生物材料已逾一年。
四、其隸屬之設置單位已註銷、撤銷或廢止其核定之生安主管、生安會或管制性生物材料主管。
五、其隸屬之設置單位已合併、裁撤、解散、歇業，或設立、登記許可已撤銷、廢止。
六、未保存、使用及處分感染性生物材料。