Pharmaceutical Affairs Act Article 16
The term “drug manufacturers” as used in this Act shall refer to the business undertakings that are engaged in manufacturing and processing drugs, wholesaling and exporting their own products, and importing raw materials for their own use.The aforementioned drug manufacturers may only import the raw materials for their own use after each import application has been approved by the central competent health authority. Raw materials for own use which have already been imported shall not be transferred or re-sold unless approved by the central competent health authority.Drug manufacturers may concurrently engage in the retailing of their own manufactured products.
中文原文 藥事法第16條
本法所稱藥品製造業者，係指經營藥品之製造、加工與其產品批發、輸出及自用原料輸入之業者。
前項藥品製造業者輸入自用原料，應於每次進口前向中央衛生主管機關申請核准後，始得進口；已進口之自用原料，非經中央衛生主管機關核准，不得轉售或轉讓。
藥品製造業者，得兼營自製產品之零售業務。
前項藥品製造業者輸入自用原料，應於每次進口前向中央衛生主管機關申請核准後，始得進口；已進口之自用原料，非經中央衛生主管機關核准，不得轉售或轉讓。
藥品製造業者，得兼營自製產品之零售業務。