Pharmaceutical Affairs Act Article 53
Drugs imported by drug dealers may be sold after repackaging conducted according to the following:1. For pharmaceutical preparations: After approval for repackaging is obtained from the central competent health authority, the repackaging shall be conducted by manufacturers that meet the GMP standards for drugs.2. For active pharmaceutical ingredients: repackaging shall be conducted by manufacturers that meet the GMP standards for drugs. After repackaging, the repacked products shall be filed with the central competent health authority for record.The conditions, procedures, timeframe, and procedure for filing the abovementioned repackaging, as well as matters to be complied with for selling the repackaged products, shall be established by the central competent health authority.
中文原文 藥事法第53條
藥品販賣業者輸入之藥品得分裝後出售，其分裝應依下列規定辦理：
一、製劑：申請中央衛生主管機關核准後，由符合藥品優良製造規範之藥品製造業者分裝。
二、原料藥：由符合藥品優良製造規範之藥品製造業者分裝；分裝後，應報請中央衛生主管機關備查。
前項申請分裝之條件、程序、報請備查之期限、程序及其他分裝出售所應遵循之事項，由中央衛生主管機關定之。
一、製劑：申請中央衛生主管機關核准後，由符合藥品優良製造規範之藥品製造業者分裝。
二、原料藥：由符合藥品優良製造規範之藥品製造業者分裝；分裝後，應報請中央衛生主管機關備查。
前項申請分裝之條件、程序、報請備查之期限、程序及其他分裝出售所應遵循之事項，由中央衛生主管機關定之。