Pharmaceutical Affairs Act Enforcement Rules Article 24

Law:: Pharmaceutical Affairs Act Enforcement Rules
Chinese:: 藥事法施行細則第24條

The items required for the registration and market approval of a drug, as referred to in Articles 39 and 40 of the Act, are as follows:1. The Chinese and foreign-language name of the drug.2. The drug's prescription and dosage form.3. The components, materials, structure, and specifications of medical devices.4. The drug's labeling, usage instructions, and packaging.5. The direct packaging of the drug.6. The indications, efficacy, properties, method of use, amount used, and type of the drug.7. The manufacturing method, the test specifications, and method of testing of the drug.8. The name of the pharmaceutical firm.9. The name and address of the factory that produces the drug.10. Other items designated for registration of the drug by the central competent health authority.

中文原文藥事法施行細則第24條

本法第三十九條、第四十條所稱藥物查驗登記事項如左：
一、藥物中文及外文品名。
二、藥品處方及藥品劑型。
三、醫療器材成分、材料、結構及規格。
四、藥物標籤、仿單及包裝。
五、藥品之直接包裝。
六、適應症、效能、性能、用法、用量及類別。
七、藥物製造方法、檢驗規格及檢驗方法。
八、藥商名稱。
九、製造廠廠名及廠址。
十、其他經中央衛生主管機關指定登記事項。

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