Pharmaceutical Affairs Act｜第 48-15 條｜Food and Drug Administration｜Act｜In Force
第 四 章｜衛生福利部 / 食品藥物管理署｜v107.01.31
Effective Date: 9999-12-31｜Last Amended: 2026-03-04
本條屬學名藥藥品許可證審查程序的銜接規定。於藥事法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，應通知申請人；申請人接獲通知後，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。此處明定「核價申請」與「得製造或輸入」是兩個不同階段。
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.
依本條第二項但書，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。接獲審查完成通知後得先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，但這與取得許可證是不同階段。