Regulations for the Issuance of Medicinal Products and Medical Devices Manufacturing Licenses and Evidentiary Documents for Good Manufacturing Practices Article 2
When a pharmaceutical manufacturer of domestic medicines and medical devices 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 a medicament manufacturing license to the manufacturer. The same shall apply when an application is made for extension of the validity period of a license under Article 4, 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2條
國產藥物製造業者經中央衛生主管機關依藥物製造業者檢查辦法之規定，檢查符合藥物優良製造準則規定者，由中央衛生主管機關核發藥物製造許可。
依第四條第二項規定，就許可有效期間申請展延者，亦同。
依第四條第二項規定，就許可有效期間申請展延者，亦同。