Pharmaceutical Affairs Act Article 48-11
For the application for a generic drug license that involves a declaration based on Subparagraph 3 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 after all of the listed patent(s) of said new drug extinguishes.
中文原文 藥事法第48-11條
學名藥藥品許可證申請案涉及第四十八條之九第三款之聲明，經審查符合本法規定者，於該新藥已登載所有專利權消滅後，由中央衛生主管機關核發藥品許可證。