Prevention of Rare Diseases and Orphan Drug Act Article 29
When an orphan drug approved through ad hoc application is used for a profit-making venture in violation of Paragraph 1 of Article 19, a fine of NT$ 30,000 to NT$ 150,000 shall be imposed; any profits thus earned shall be confiscated, and the offender shall be prohibited from submitting an ad hoc application for an orphan drug for two years.
中文原文 罕見疾病防治及藥物法第29條
違反第十九條第一項規定，將專案申請之罕見疾病藥物充作營利用途者，處新台幣三萬元以上十五萬元以下罰鍰；其獲取之利益，沒入之；二年內並不得再行提出罕見疾病藥物之專案申請。