Pharmaceutical Affairs Act Enforcement Rules Article 5
The term "manufactured without prior approval" as used in Article 20, subparagraph 1 does not include drugs under research or in trial production that are not for sale.The drugs of the preceding paragraph shall be ones for which there is a record of research or trial production and are restricted to those that are not packaged as a marketable product.
中文原文 藥事法施行細則第5條
本法第二十條第一款所稱未經核准，擅自製造者，不包括非販賣之研究、試製之藥品。
前項藥品應備有研究或試製紀錄，並以無商品化之包裝者為限。
前項藥品應備有研究或試製紀錄，並以無商品化之包裝者為限。