Prevention of Rare Diseases and Orphan Drug Act Article 18
Under any of the following conditions, the central competent authority may, irrespective of the restrictions stipulated in Paragraph 1 of the preceding Article, accept applications for registration and market approval of other pharmaceuticals of the same kind and issue permits:1.A new applicant has obtained authorized consent from the holder of rights to an orphan drug that has received registration and market approval;2.An orphan drug for which a new application is being submitted has the same indications and is of similar quality to an orphan drug that has already been approved, and is safer or more efficacious than the approved drug;3.The holder of an orphan drug permit is unable to meet the demand for said drug;4.The price of an orphan drug is determined by the central competent authority to be unreasonable.When registration and market approval are received and permits are granted under Subparagraph 2 through Subparagraph 4 of the preceding Paragraph, the said permits shall be subjected to the provisions of the preceding Article.
中文原文 罕見疾病防治及藥物法第18條
有下列情形之一者，中央主管機關得不受前條第一項規定之限制，受理其他同類藥物之查驗登記申請，並發給許可證：
一、新申請人取得經查驗登記許可為罕見疾病藥物之權利人授權同意。
二、具相同適應症且本質類似之罕見疾病藥物之新申請案，其安全性或有效性確優於已許可之罕見疾病藥物。
三、持有罕見疾病藥物許可證者無法供應該藥物之需求。
四、罕見疾病藥物售價經中央主管機關認定顯不合理。
依前項第二款至第四款規定經中央主管機關查驗登記發給許可證者，適用前條之規定。
一、新申請人取得經查驗登記許可為罕見疾病藥物之權利人授權同意。
二、具相同適應症且本質類似之罕見疾病藥物之新申請案，其安全性或有效性確優於已許可之罕見疾病藥物。
三、持有罕見疾病藥物許可證者無法供應該藥物之需求。
四、罕見疾病藥物售價經中央主管機關認定顯不合理。
依前項第二款至第四款規定經中央主管機關查驗登記發給許可證者，適用前條之規定。