Regulations for the Patent Linkage of Drugs Article 13
Under any circumstances set forth in the proviso of Paragraph 2 of Article 48-13 in the Act, the applicant for a generic drug permit license shall specify the specific circumstance and its occurring date, and present relevant documents and information to the Central Competent Health Authority for review.
中文原文 西藥專利連結施行辦法第13條
有本法第四十八條之十三第二項但書各款情事之一者，學名藥藥品許可證申請人應敘明各該情事及發生日期，並檢附相關證明文件、資料，送中央衛生主管機關審查。