Prevention of Rare Diseases and Orphan Drug Act Article 28
When false documentation is submitted during application for orphan drug registration and market approval or permit extension, a fine of NT$ 20,000 to NT$ 100,000 shall be imposed, and the offender shall be prohibited from applying for registration and market approval for said pharmaceutical for two years; where a permit has already been obtained, said permit shall be revoked; cases where criminal liability is involved it shall be turned over to the judiciary for prosecution.
中文原文 罕見疾病防治及藥物法第28條
申請罕見疾病藥物查驗登記或展延登記，提供不實之書證資料者，處新台幣二萬元以上十萬元以下之罰鍰，二年內不得再申請該藥物之查驗登記；其已領取該藥物許可證者，撤銷之；其涉及刑責者，移送司法機關辦理。