Prevention of Rare Diseases and Orphan Drug Act Article 27
A fine of NT$ 30,000 to NT$ 150,000 shall be imposed for violation of Article 16; for major violations, pharmaceutical firms shall be prohibited from applying for registration and market approval for said pharmaceutical for two years, and the operations of medical care institutions may be suspended for a period of one month to one year.
中文原文 罕見疾病防治及藥物法第27條
違反第十六條規定者，處新台幣三萬元以上十五萬元以下罰鍰；其情節重大者，藥商於二年內不得再申請該藥物之查驗登記，並得處醫療機構一個月以上一年以下停業處分。