Enforcement Rules for the Controlled Drugs Act Article 13

A person who applies to the FDA for a permit for importing 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 drug import and 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 copies of the documents mentioned above to the FDA for references 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 imported. However, records reported in accordance with Article 26 need not be enclosed.
中文原文 管制藥品管理條例施行細則第13條
依本條例第二十條規定向食品藥物署申請核發第三級、第四級管制藥品輸入同意書者,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輸入、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、申請輸入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。

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