Regulations for the Issuance of Medicinal Products and Medical Devices Manufacturing Licenses and Evidentiary Documents for Good Manufacturing Practices Article 7
The approval document showing conformity with the Pharmaceutical Good Manufacturing Practice Regulations by a foreign manufacturer of imported medicinal products is valid for a period of 2 years. If the dosage form of the product manufactured, the nature of the operation performed, and the records in successive inspections are good, it may be extended for 1 to 2 years. The approval document showing conformity with the Pharmaceutical Good Manufacturing Practice Regulations by a foreign manufacturer of imported medical devices is valid for a period of 3 years.Six months prior to the expiration of the valid period of the approval document, the pharmaceutical firm that is the agent for import shall apply to the central competent health authority for an extension.
中文原文 藥物製造許可及優良製造證明文件核發辦法第7條
輸入藥品國外製造廠符合藥物優良製造準則之核定文件，有效期間為二年；其生產產品之劑型、作業內容及歷次檢查紀錄良好者，得增加一年至二年。
輸入醫療器材國外製造廠符合藥物優良製造準則之核定文件，有效期間為三年。
代理輸入之藥商應於核定文件有效期間屆滿六個月前，向中央衛生主管機關申請展延。
輸入醫療器材國外製造廠符合藥物優良製造準則之核定文件，有效期間為三年。
代理輸入之藥商應於核定文件有效期間屆滿六個月前，向中央衛生主管機關申請展延。