Veterinary Drugs Control Act Article 25
The special municipal or county (city) competent authority shall dispatch personnel to inspect the premises and equipment of a veterinary drug manufacturer – regarding its manufacturing process, apparatus, quality control, and record-keeping – on a regular basis.When necessary, the central competent authority may dispatch personnel to conduct spot-checking within the scope set in the preceding Paragraph.When the competent authority arrives to conduct an inspection or spot-checking, the veterinary drug manufacturer must not refuse without due cause.If the special municipal or county (city) competent authority decides there is still rooms for improvement after the inspection described in Paragraph 1, it shall inform the entity to rectify the issues before a set deadline; failure to rectify may result in a report to the central competent authority seeking an order to suspend the entity's production of part or all veterinary drugs at the factory. Continued production – despite a suspension order – may result in a report to the central competent authority seeking annul the entity's veterinary drug manufacture license.
中文原文 動物用藥品管理法第25條
直轄市及縣(市)主管機關,對動物用藥品製造業者之製造場所及其設備,就其製造程序、裝置、品質管制及有關資料等,應定期派員檢查之。
中央主管機關於必要時,得就前項所定範圍派員抽查之。
主管機關檢查或抽查時,動物用藥品製造業者不得無故拒絕。
直轄市或縣(市)主管機關對於第一項檢查結果,認有應改善之處,應通知限期改善;屆期不改善者,得報請中央主管機關令其停止部分或全部動物用藥品之製造。
經停止製造之動物用藥品,仍繼續製造者,得報請中央主管機關廢止其製造動物用藥品許可證。
中央主管機關於必要時,得就前項所定範圍派員抽查之。
主管機關檢查或抽查時,動物用藥品製造業者不得無故拒絕。
直轄市或縣(市)主管機關對於第一項檢查結果,認有應改善之處,應通知限期改善;屆期不改善者,得報請中央主管機關令其停止部分或全部動物用藥品之製造。
經停止製造之動物用藥品,仍繼續製造者,得報請中央主管機關廢止其製造動物用藥品許可證。