Pharmaceutical Affairs Act Article 47

A medicament manufacture or import license shall be valid for five (5) years. Where it is necessary to continue the manufacture or import of medicament upon expiration, a prior application shall be filed with the central competent authority for approval of license extension. The term of each extension shall not exceed five (5) years. The license shall be revoked upon expiry of the term thereof if the license holder fails to apply for an extension or if the application for an extension is disapproved.In case a license set forth in the preceding paragraph is stained, damaged, or lost, an application specifying the cause shall be filed with the original issuing authority for replacement or re-issuance; the original license shall be revoked or canceled through public notice by the issuing authority.
中文原文 藥事法第47條
藥物製造、輸入許可證有效期間為五年,期滿仍須繼續製造、輸入者,應事先申請中央衛生主管機關核准展延之。
但每次展延,不得超過五年。
屆期未申請或不准展延者,註銷其許可證。
前項許可證如有污損或遺失,應敘明理由,申請原核發機關換發或補發,並應將原許可證同時繳銷,或由核發機關公告註銷。

English translation for reference only; the Chinese text prevails. Not legal advice.