Pharmaceutical Affairs Act Article 20
The term “counterfeit drugs” as used in this Act shall refer to the drugs that are found to fall within any of the following circumstances after inspection or testing:1. The drugs that are manufactured without prior approval;2. The active ingredients of the drugs are inconsistent with the ingredients thereof previously approved;3. The drugs that are packed or alternated with the products of others; or4. The duration of validity label of the drugs has been altered or replaced.
中文原文 藥事法第20條
本法所稱偽藥，係指藥品經稽查或檢驗有左列各款情形之一者：
一、未經核准，擅自製造者。
二、所含有效成分之名稱，與核准不符者。
三、將他人產品抽換或摻雜者。
四、塗改或更換有效期間之標示者。
一、未經核准，擅自製造者。
二、所含有效成分之名稱，與核准不符者。
三、將他人產品抽換或摻雜者。
四、塗改或更換有效期間之標示者。