Regulations for Registration of Medicinal Products Article 14

Product names should comply with the following regulations:1.Do not use the other manufacturer’s name or trademark as a product name, except in the case the use has been authorized;2.Products named after items in pharmacopoeias, common names or conventional formulas should include the company’s name or trademark or any distinguishable title as a prefix; but, this naming rule does not apply to export only products;3.Product names can not be identical to any other exiting product names. Counterfeiting or insinuation is not allowed;4.Product names should not be deceitful or exaggerated, nor should they give any misinterpretation on product efficacy;5.Chinese product names should not include any foreign letters or numbers, unless therein lies real meanings;6.For drugs whose licenses have been revoked pursuant to the Acts, their product names are banned from use for two years; but, this two-year ban does not apply to the following situations: the application is a re-submission according to the condition stated in Article 72 Paragraph 1; or, the original license is changed to export-only license; or, the reasons of the revocation or cancellation of an export-only license are irrelevant to drug safety or effectiveness. With the central health competent authority’s approval, the manufacturer can name the drugs with identical ingredients, dosage form, dose and efficacy for the original names.7.If a manufacturer gave compounds with different formulas the same product name, then their Chinese product names should contain proper words or terms to clearly distinguish their differences in efficacy; and8.Names that are inappropriate for pharmaceutical products shall not be used.In order of priority, whether product names are identical or similar is judged on trademarks, the manufacturer’s name and other distinguishable names. However, in the situation described in Item 3 in the preceding paragraph, the manufacturer’s name and trademark will not be included in the comparison.For drug items already granted with market licenses, the central health competent authority may reassess their product names pursuant to the previous two paragraphs.
中文原文 藥品查驗登記審查準則第14條
藥品品名,應符合下列規定:
一、品名不得使用他人藥物商標或廠商名稱。
但取得所用廠商名稱之商標權者,不在此限。
二、以藥典記載之名稱、學名、通俗名稱或固有成方名稱為品名者,應加冠商標、廠商名稱或其他可資辨別之名稱。
但外銷專用品名,不在此限。
三、品名不得與其他廠商藥品品名相同,或涉及仿冒或影射情事。
四、品名不得涉有虛偽或誇大,或使人對品名與效能產生不當聯想或混淆。
五、中文品名不得夾雜外文或數字。
但具直接意義者,不在此限。
六、依本法撤銷許可證之藥品,其品名不得再使用;依本法註銷或廢止許可證之藥品,二年內其品名不得再使用。
但依第七十二條第一項但書規定重新申請查驗登記、原有許可證變更為外銷專用許可證或外銷專用許可證之註銷或廢止原因與藥品之安全或療效無關者,經中央衛生主管機關核准後,同一廠商得將原品名使用於同成分、同劑型、同劑量且同療效之藥品,不受二年內不得再使用之限制。
七、同一廠商對於不同處方之複方製劑而使用相同品名者,應於中文品名中,以適當字詞明顯區分其藥品之不同效能。
八、不得有其他不適合為藥品名稱之情形。
認定藥品品名是否相同或近似之標準,依商標、廠商名稱或其他可資辨別名稱之順位認定之。
但前項第三款之認定,廠商名稱及劑型不列入比對。
已核准上市之藥品許可證,中央衛生主管機關得依前二項規定,重新審查核定其藥品品名。

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