Pharmaceutical Affairs Act Article 48-8
1. The central competent health authority shall establish a Registration System for Patent Linkage of Drugs to list and publish the patent information submitted by the new drug license holder. The aforementioned shall also apply to the amendment and deletion of the patent information.2. Upon the occurrence of the matters stipulated in Article 48-7 for the listed patent information, the central competent health authority shall publish the third party’s allegations and the written responses made by the new drug license holder.
中文原文 藥事法第48-8條
中央衛生主管機關應建立西藥專利連結登載系統,登載並公開新藥藥品許可證所有人提報之專利資訊;專利資訊之變更或刪除,亦同。
登載之專利資訊有前條所定情事者,中央衛生主管機關應公開前條通知人之主張及新藥藥品許可證所有人之書面回覆。
登載之專利資訊有前條所定情事者,中央衛生主管機關應公開前條通知人之主張及新藥藥品許可證所有人之書面回覆。