Pharmaceutical Affairs Act Enforcement Rules Article 31

When, in response to the demands of buyers in the export destination, the name, labeling, usage instructions, or packaging of export drugs must be made different from those for the domestically sold ones or a foreign language text must be appended, it shall be done according to the provisions of the Regulations for Registration of Medicinal Products and Regulation for Registration of Medical Devices.The aforementioned drugs shall not be sold domestically.
中文原文 藥事法施行細則第31條
輸出藥物為應輸出地區購買者之要求,其藥物名稱、標籤、仿單、包裝或附加外文,有與內銷相異之必要者,應依藥品查驗登記審查準則及醫療器材查驗登記審查準則之規定辦理。
前項藥物,不得用於內銷。

English translation for reference only; the Chinese text prevails. Not legal advice.