Enforcement Rules of the Rare Diseases and Orphan Drugs Act Article 9
The right-holders of orphan drugs mentioned in Subparagraph 1, Paragraph 1, Article 18 of this Act, refer to persons who own permit licenses of the orphan medical products.
中文原文 罕見疾病防治及藥物法施行細則第9條
本法第十八條第一項第一款所稱罕見疾病藥物之權利人，指領有罕見疾病藥物許可證者。