Pharmaceutical Affairs Act Enforcement Rules Article 27
For drugs produced in Taiwan, the labeling, usage instructions, and packaging shall be primarily in Chinese. Any appended text in a foreign language shall be smaller than the Chinese. However, this does not apply to export drugs.Chinese usage instructions shall be appended to foreign imported drugs, and both their labeling and packaging shall bear the product's name, type, and registration number, and the name and address of the importing pharmaceutical firm, in Chinese. The period of validity or shelf life of the drug shall be labeled in Chinese or by the use of a commonly recognized labeling method. The lettering of the Chinese product name may not be smaller than the lettering of the foreign language name.
中文原文 藥事法施行細則第27條
國內製造之藥物,其標籤、仿單、包裝應以中文為主,所附外文文字應小於中文。
但輸出之藥物,不在此限。
國外輸入之藥物,除應加附中文仿單外,其標籤、包裝均應另以中文載明品名、類別、許可證字號及輸入藥商名稱、地址,且應以中文或依習慣能辨明之方式刊載有效期間或保存期限;其中文品名之文字不得小於外文。
但輸出之藥物,不在此限。
國外輸入之藥物,除應加附中文仿單外,其標籤、包裝均應另以中文載明品名、類別、許可證字號及輸入藥商名稱、地址,且應以中文或依習慣能辨明之方式刊載有效期間或保存期限;其中文品名之文字不得小於外文。