Pharmaceutical Affairs Act Article 48-10
For the application for a generic drug license that only involves a declaration based on Subparagraph 1 or 2 of Article 48-9, if in compliance with the regulations under this Act after examination, the central competent health authority shall issue the drug license thereof.
中文原文 藥事法第48-10條
學名藥藥品許可證申請案僅涉及前條第一款或第二款之聲明，經審查符合本法規定者，由中央衛生主管機關核發藥品許可證。