Enforcement Rules of the Rare Diseases and Orphan Drugs Act Article 11
The failure to meet demands for the drugs mentioned in Subparagraph 3, Paragraph 1, Article 18 of the Act, refers to the failure of the right-holders in supplying in sufficient amount medical products of the rare diseases and those who have been notified by the central competent authority to improve in due time and have not made improvement yet.
中文原文 罕見疾病防治及藥物法施行細則第11條
本法第十八條第一項第三款所稱無法供應該藥物之需求，指權利人未能充分供應該罕見疾病藥物，經中央主管機關令其限期改善，屆期仍未改善者。