Regulations for the Issuance of Medicinal Products and Medical Devices Manufacturing Licenses and Evidentiary Documents for Good Manufacturing Practices Article 5
When the foreign manufacturer of imported medicinal products has been inspected by the central competent health authority in accordance with the Regulations of Medicament Manufacturer Inspection and found to meet the requirements of the Pharmaceutical Good Manufacturing Practice Regulations, the central competent health authority shall issue an approval document. The same shall apply when an application is made for extension of the validity period of an approval document under Article 7, paragraph 2.
中文原文 藥物製造許可及優良製造證明文件核發辦法第5條
輸入藥物國外製造廠經中央衛生主管機關依藥物製造業者檢查辦法規定，檢查符合藥物優良製造準則規定者，由中央衛生主管機關發給核定文件。
依第七條第二項規定，就核定文件有效期間申請展延者，亦同。
依第七條第二項規定，就核定文件有效期間申請展延者，亦同。