Pharmaceutical Affairs Act Article 48-14
For the application for the generic drug license filed by the same applicant for the same drug, the central competent health authority may only stay the issuance of the drug license in accordance with Paragraph 2, Article 48-13 once.
中文原文 藥事法第48-14條
學名藥藥品許可證申請案，其申請人為同一且該藥品為同一者，中央衛生主管機關依前條第二項暫停核發藥品許可證之次數，以一次為限。