Pharmaceutical Affairs Act Enforcement Rules Article 22-1
To apply for the importation of active pharmaceutical ingredients for the trial production of a drug in accordance with Article 39, paragraph 2 of the Act, an application fee shall be paid and an application form, along with the following materials, submitted to the central competent health authority for approval:1. The pharmaceutical firm's permit license.2. A written trial production plan.3. The factory registration documents issued by the Ministry of Economic Affairs. Research and development organizations are exempt from this requirement.4. When another pharmaceutical firm is contracted to handle the importation of active pharmaceutical ingredients for trial production of a drug, the letter of instruction and the pharmaceutical firm permit licenses of the contracting party and the contractor are required.
中文原文 藥事法施行細則第22-1條
依本法第三十九條第二項規定申請輸入試製藥品原料藥者，應繳納費用，並填具申請書及檢附下列資料，送請中央衛生主管機關核辦：
一、藥商許可執照。
二、試製計畫書。
三、經濟部工廠登記證明文件。
但研發單位，免附。
四、委託其他藥商辦理輸入試製藥品原料藥者，其委託書、委託者及受委託者之藥商許可執照。
一、藥商許可執照。
二、試製計畫書。
三、經濟部工廠登記證明文件。
但研發單位，免附。
四、委託其他藥商辦理輸入試製藥品原料藥者，其委託書、委託者及受委託者之藥商許可執照。