Regulations for the Issuance of Medicinal Products and Medical Devices Manufacturing Licenses and Evidentiary Documents for Good Manufacturing Practices Article 4
The manufacturing license for a manufacturer of domestically produced medicinal products is valid for 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 manufacturing license for a manufacturer of domestically produced medical devices is valid for 3 years.Six months prior to the expiration of the period of validity of its medicament manufacturing license, a medicament manufacturer 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4條
國產藥品製造業者之製造許可，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。
國產醫療器材製造業者之製造許可，有效期間為三年。
藥物製造業者應於藥物製造許可有效期間屆滿六個月前，向中央衛生主管機關申請展延。
國產醫療器材製造業者之製造許可，有效期間為三年。
藥物製造業者應於藥物製造許可有效期間屆滿六個月前，向中央衛生主管機關申請展延。