Controlled Drugs Act Article 20
Besides obtaining the drug permit license as prescribed in Article 39 of the Act of Pharmaceutical Affairs, the import, export and manufacturing of Schedule 3 and 4 controlled drugs shall apply to the FDA for a permit on a batch by batch basis. However, if the actions are permitted by the central competent health authority because of special demand, they shall be exempted.
中文原文 管制藥品管理條例第20條
第三級、第四級管制藥品之輸入、輸出及製造，除依藥事法第三十九條規定取得許可證外，應逐批向食品藥物署申請核發同意書。
但因特殊需要，經中央衛生主管機關許可者，不在此限。
但因特殊需要，經中央衛生主管機關許可者，不在此限。