Regulations Governing Management of Infectious Biological Materials Article 19
For the import and export of infectious biological materials, an entity shall submit an application and relevant documents to the central competent authority for approval according to Paragraph 2, Article 34 of the Act.In the event that infectious biological materials to be imported or exported in the preceding paragraph are pathogens in Risk Groups 2-4 or biotoxins, their import and export must be reviewed and approved by the BSO, and in addition, reviewed and approved by the IBC if the entity has an IBC set up.In the event that infectious biological materials to be imported or exported in Paragraph 1 hereof are BSAT, their import and export must be reviewed and approved by the BSAT officer and the IBC, and consent documents from the IBC of the entity shall be enclosed with the application.
中文原文 感染性生物材料管理辦法第19條
設置單位輸出入感染性生物材料，應依本法第三十四條第二項規定，檢具申請書及相關文件、資料，向中央主管機關申請核准。
前項輸出入之感染性生物材料為第二級至第四級危險群病原體及生物毒素者，應經生安主管審查通過，其設有生安會者，並應經生安會審議通過。
第一項輸出入之感染性生物材料為管制性生物材料者，並應經管制性生物材料主管審查及生安會審議通過，且檢具生安會之同意文件。
前項輸出入之感染性生物材料為第二級至第四級危險群病原體及生物毒素者，應經生安主管審查通過，其設有生安會者，並應經生安會審議通過。
第一項輸出入之感染性生物材料為管制性生物材料者，並應經管制性生物材料主管審查及生安會審議通過，且檢具生安會之同意文件。