Enforcement Rules of the Rare Diseases and Orphan Drugs Act Article 1
This set of Rules is formulated in accordance with the regulations of Article 35 of the Rare Diseases and Orphan Drugs Act (hereafter referred to as the Act).
中文原文 罕見疾病防治及藥物法施行細則第1條
本細則依罕見疾病防治及藥物法（以下稱本法）第三十五條規定訂定之。