Enforcement Rules for the Controlled Drugs Act Article 14

A person who applies to the FDA for a permit for exporting Schedule 3 and 4 controlled drugs in accordance with Article 20 of this Act shall prepare the application with the following documents enclosed:1. The copies of manufacture permit license issued by the Central Health or Agricultural Administration, or of the approved medical and educational research projects. However, one who has sent the copies of the documents mentioned above to the FDA for reference need not to enclose them.2. The records of increase and decrease of stocks for the month prior to the date of application of the applied controlled drugs sought to be exported. However, records reported in accordance with Article 26 need not be enclosed.3. The import permit from the importing state government. The FDA may request such documents shall be authenticated by an embassy, consulate, or representative office of the R.O.C., or other institute or office authorized by the Ministry of Foreign Affairs if necessary.
中文原文 管制藥品管理條例施行細則第14條
依本條例第二十條規定向食品藥物署申請核發第三級、第四級管制藥品輸出同意書者,應備具申請書,並檢附下列文件:
一、中央衛生或農業主管機關核發之藥品製造許可證影本或經核准之醫藥教育研究試驗計畫文件影本。
但上開證件影本已送食品藥物署備查者,無須檢附。
二、申請輸出之管制藥品於申請日前月之收支結存情形。
但已依第二十六條規定申報者,無須檢附。
三、輸入國政府核准輸入之許可文件;必要時,食品藥物署得要求該文件先經我國駐外使領館、代表處、辦事處或其他外交部授權機構之驗證。

English translation for reference only; the Chinese text prevails. Not legal advice.