Regulation for Drug Shortage Management Article 4
Applicants for the special case approval to manufacture or import must have the eligibility of a pharmaceutical firm. Priority shall be given to manufacturers that manufacture or sell drugs in any of the member countries under PIC/S, or those that comply with Article 3 of the Pharmaceutical Good Manufacturing Practice Regulations.
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4條
申請專案核准製造或輸入，應具備藥商資格，並以藥品於國際醫藥品稽查協約組織（PIC/S）會員國製造或販賣、或符合藥物優良製造準則第三條規定之製造廠優先。