Prevention of Rare Diseases and Orphan Drug Act Article 31
When a pharmaceutical firm violates the provisions of Paragraph 2 of Article 21, a fine of NT$ 10,000 to NT$ 50,000 shall be imposed; when the offender is an ad hoc applicant, the central competent authority may deny further orphan drug permit applications made by the said offender.
中文原文 罕見疾病防治及藥物法第31條
違反第二十一條第二項規定，藥商處新台幣一萬元以上五萬元以下之罰鍰；專案申請者，其再申請罕見疾病藥物，中央主管機關得不予許可。