Regulations for Issuance of License of Specific Purpose Cosmetics Article 4
An applicant applies for the registration of the license for manufacturing specific purpose cosmetics per Paragraph 1 of Article 5 of the Act shall submit an application with following documents, and pay the fee to the central competent authority:1. A copy of the factory registration certificate.2. A copy of the license of the pharmacist in charge of supervision of manufacturing, or employment certificate and qualification of personnel who is stationed at the factory to supervise the dispensation and manufacturing.3. Drafts of product labels, leaflets, and packaging.4. The certificate of analysis.5. For the contract manufacturer, a copy of company registration or business registration certificate of the applicant and the OEM agreement.A cosmetic manufacturing facility receives the certificate of cosmetic Good Manufacturing Practice by law, and applies for specific purpose cosmetics license for the same dosage form stated in such certificate, the certificate of analysis mentioned in Sub-paragraph 4 of the preceding Paragraph may be replaced with such certificate.
中文原文 特定用途化粧品許可證核發辦法第4條
依本法第五條第一項規定申請查驗登記發給製造特定用途化粧品許可證者，應填具申請書，檢附下列文件、資料，並繳納費用，向中央主管機關提出：
一、工廠登記證明文件影本。
二、監製藥師執業執照影本，或駐廠監督調配製造人員資格及在職證明。
三、產品標籤、仿單及包裝設計稿樣。
四、檢驗成績書。
五、委託製造者，其申請者之公司登記或商業登記證明文件影本及委託契約。
化粧品製造場所依法令規定取得化粧品優良製造規範證明文件，以該證明文件所載相同劑型申請特定用途化粧品許可證者，前項第四款檢驗成績書得以該證明文件代之。
一、工廠登記證明文件影本。
二、監製藥師執業執照影本，或駐廠監督調配製造人員資格及在職證明。
三、產品標籤、仿單及包裝設計稿樣。
四、檢驗成績書。
五、委託製造者，其申請者之公司登記或商業登記證明文件影本及委託契約。
化粧品製造場所依法令規定取得化粧品優良製造規範證明文件，以該證明文件所載相同劑型申請特定用途化粧品許可證者，前項第四款檢驗成績書得以該證明文件代之。