Regulations for Registration of Medicinal Products Article 90

Law:: Regulations for Registration of Medicinal Products
Chinese:: 藥品查驗登記審查準則第90條

Unless otherwise provided in this Chapter, the authorization letter, FSC from the country of origin, batch record and manufacturing and controls standards, form for sticking changed licenses and certificates, references and research reports, the applicant field on the application form, and outsourced manufacturing and inspection shall be subject to Article 5, Article 6, Article 11, Article 12, Article 13, Paragraphs 1 and 3 of Article 16, and Article 23, respectively.If any of the following conditions occurs, applications concerning Chinese medicine shall be rejected:1. Any of the conditions listed in Article 25 occurs.2. Another application is submitted for products with the same dosage form on the same formulation basis. However, this provision is not applicable to those made into different sizes of pills, tablets, or capsules, as well as excipients made of different aromatics, coloring agents or flavors.

中文原文藥品查驗登記審查準則第90條

除本章另有規定外，委託書、出產國許可製售證明、批次製造紀錄與製造管制標準書、已完成變更之證照與黏貼表、檢附之文獻資料與研究報告、申請書之申請者欄、委託製造及檢驗，分別準用第五條、第六條、第十一條至第十三條、第十六條第一項、第三項及第二十三條規定。
中藥申請案件，有下列情形之一者，不予核准：
一、有第二十五條各款情事之一。
二、重複申請同處方依據之同劑型。
但做成大小丸、錠或膠囊，及以不同香料、色素或矯味劑做成賦形劑者，不在此限。

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