Regulation for Drug Shortage Management Article 10
With regard to the essential drug or substitute drug approved for manufacture or import, pharmaceutical firms should execute the project in accordance with the quantity and period approved by the Central Competent Health Authority, as well as other supplementary provisions. In the case that changes have to be made to an approved item, the changes must be approved before execution.
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10條
專案核准製造或輸入之必要藥品或其替代藥品，藥商應依中央衛生主管機關核准之數量、期限與其他內容及附款事項執行；其核准事項有變更必要者，應經核准，始得為之。