Pharmaceutical Affairs Act Article 48
If there is a safety or medical efficacy concern of medicaments as re-evaluated and confirmed by the central competent health authority within the validity period of the manufacture or import license, pharmaceutical firms may be ordered to rectify any concerns within a time limit. For those who fail to make corrections within the given time limit, their licenses shall be revoked. Where there is a serious safety concern, the central competent health authority may revoke the license directly.
中文原文 藥事法第48條
藥物於其製造、輸入許可證有效期間內，經中央衛生主管機關重新評估確定有安全或醫療效能疑慮者，得限期令藥商改善，屆期未改善者，廢止其許可證。
但安全疑慮重大者，得逕予廢止之。
但安全疑慮重大者，得逕予廢止之。