Pharmaceutical Affairs Act Article 48-15
During the period of stay of drug license issuance stipulated in Paragraph 2 of Article 48-13, if the examination for the application for a generic drug license has been completed, the central competent health authority shall inform the applicant for said generic drug license.The applicant for a generic drug license may apply for drug listing and reimbursement price with the National Health Insurance Administration after receiving the notification stipulated in Paragraph 1 hereof. However, no manufacture or importation of the generic drug is permitted before the central competent health authority’s issuance of the generic drug license.
中文原文 藥事法第48-15條
於第四十八條之十三第二項暫停核發藥品許可證期間，中央衛生主管機關完成學名藥藥品許可證申請案之審查程序者，應通知學名藥藥品許可證申請人。
學名藥藥品許可證申請人接獲前項通知者，得向衛生福利部中央健康保險署申請藥品收載及支付價格核價。
但於中央衛生主管機關核發學名藥藥品許可證前，不得製造或輸入。
學名藥藥品許可證申請人接獲前項通知者，得向衛生福利部中央健康保險署申請藥品收載及支付價格核價。
但於中央衛生主管機關核發學名藥藥品許可證前，不得製造或輸入。