Veterinary Drugs Control Act Article 14

A license to manufacture or import veterinary drugs is valid for a maximum of five years; entities intending to continue to manufacture or import shall apply with the central competent authority for renewal two to six months before the expiration date; such renewal may not exceed five years each; licenses are rendered invalid if no renewal is sought on the expiration date or the renewal is denied; such invalidated licenses are to be promulgated by the central competent authority in a government gazette.During the valid period of a license described in the preceding Paragraph, the central competent authority may, for the protection of animal and human health or other major concerns, reevaluate the specific licensed veterinary drug and restrict its usage and scope; if necessary, a license referred to in the preceding Paragraph may be annulled.For the review of importation license application, renewal, reevaluation referred to in the preceding Paragraph, or for actual needs, the central competent authority may send personnel to the specific veterinary drug' s overseas manufacturing factory for verification; expenses incurred shall be governed by relevant regulations, and be borne by the entity importing the veterinary drug concerned.
中文原文 動物用藥品管理法第14條
製造或輸入動物用藥品許可證有效期間最長為五年,期滿仍擬繼續製造或輸入者,應於期限屆滿之日前二個月至六個月內,向中央主管機關申請展延,每次展延期間,不得超過五年;屆期未辦理展延或不准展延者,原許可證失效,由中央主管機關刊登政府公報。
在前項許可證有效期間內,基於維護動物、人體健康或其他重大原因,中央主管機關得重新評估該動物用藥品,並限制其使用方法、範圍;必要時,得廢止前項許可證。
中央主管機關為審查輸入動物用藥品許可證之申請、展延、依前項規定重新評估或因應其他實際需要,得派員至該動物用藥品之國外製造廠查核之;所需費用應依相關法令規定,並由經營該動物用藥品之輸入業者負擔。

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