Pharmaceutical Good Manufacturing Practice Regulations Article 3
The manufacturing, processing, re-packaging, packaging, storage, and distribution of Western medicinal products, including those only for export, shall comply with the good manufacturing practices for Western medicinal products adopted by the competent central health authority with reference to the Pharmaceutical Inspection Convention and Pharmaceutical Inspection Co-operation Scheme (PIC/S). Implementation of the aforesaid good manufacturing practices may be phased in; the items to which the phased-in implementation applies and the related schedules shall be announced by the competent central health authority.
中文原文 藥物優良製造準則第3條
西藥藥品含外銷專用產品之製造、加工、分裝、包裝、儲存及運銷，應符合中央衛生主管機關參照國際醫藥品稽查協約組織（PIC/S）其規範所訂定之西藥藥品優良製造規範。
該規範之適用，得分階段施行；其分階段施行之項目、時程，由中央衛生主管機關公告之。
該規範之適用，得分階段施行；其分階段施行之項目、時程，由中央衛生主管機關公告之。