Pharmaceutical Affairs Act Article 48-7
Anyone may notify any of the following items to the central competent health authority with written explanations and evidence attached:1. The invention listed in the patent information is irrelevant to the approved drug.2. The invention listed in the patent information does not comply with Paragraph 2 of Article 48-3.3. The patent information listed is incorrect.4. No amendment or deletion has been made for any of the occurrences stipulated in Article 48-6.The central competent health authority shall, within 20 days after the next day of its receipt of the notification under Paragraph 1 hereof, forward said notification to the new drug license holder.The new drug license holder shall, within 45 days of the next day of its receipt of said notification, respond to the central competent health authority with written explanations and may amend or delete the patent information as the case may be.
中文原文 藥事法第48-7條
有下列情事之一者，任何人均得以書面敘明理由及附具證據，通知中央衛生主管機關：
一、已登載專利資訊之發明，與所核准之藥品無關。
二、已登載專利資訊之發明，不符第四十八條之三第二項規定。
三、已登載之專利資訊錯誤。
四、有前條所定情事而未辦理變更或刪除。
中央衛生主管機關應自接獲前項通知之次日起二十日內，將其轉送新藥藥品許可證所有人。
新藥藥品許可證所有人自收受通知之次日起四十五日內，應以書面敘明理由回覆中央衛生主管機關，並得視情形辦理專利資訊之變更或刪除。
一、已登載專利資訊之發明，與所核准之藥品無關。
二、已登載專利資訊之發明，不符第四十八條之三第二項規定。
三、已登載之專利資訊錯誤。
四、有前條所定情事而未辦理變更或刪除。
中央衛生主管機關應自接獲前項通知之次日起二十日內，將其轉送新藥藥品許可證所有人。
新藥藥品許可證所有人自收受通知之次日起四十五日內，應以書面敘明理由回覆中央衛生主管機關，並得視情形辦理專利資訊之變更或刪除。