Regulation for Drug Shortage Management Article 8
Applicants for special case approval to manufacture or import must meet the following standards and be approved by the Central Competent Health Authority before they can proceed:1.Drugs must be proven via assessment to be effective enough to replace essential drugs that face a possible shortage in supply.2.The drug for special case application should have once been approved for manufacture or sale either in Taiwan or overseas. However, drugs that have been approved by the Central Competent Health Authority are not restricted by this provision.3.Manufacturers applying for special case approval to manufacture or import must not have seriously violated Article 3 of the Pharmaceutical Good Manufacturing Practice Regulations within the last three years.When the approved volume of special case manufacture or import can meet the demand for the essential drug or its substitute drug, other applications shall not be approved.
中文原文 必要藥品短缺通報登錄及專案核准製造輸入辦法第8條
申請專案核准製造或輸入，應符合下列基準，並經中央衛生主管機關核准，始得為之：
一、經評估其效能得以取代有供應不足之虞之必要藥品者。
二、專案申請之藥品為國內或國外曾核准製造及販賣之藥品。
但經中央衛生主管機關認可者，不在此限。
三、申請專案製造或輸入者之製造廠，於近三年內未有嚴重違反藥物優良製造準則第三條規定之情形者。
已核准專案製造或輸入之數量，足供必要藥品或其替代藥品之需求者，其他申請案得不予核准。
一、經評估其效能得以取代有供應不足之虞之必要藥品者。
二、專案申請之藥品為國內或國外曾核准製造及販賣之藥品。
但經中央衛生主管機關認可者，不在此限。
三、申請專案製造或輸入者之製造廠，於近三年內未有嚴重違反藥物優良製造準則第三條規定之情形者。
已核准專案製造或輸入之數量，足供必要藥品或其替代藥品之需求者，其他申請案得不予核准。