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[null,"國產化粧品優先審查申請暨切結書",{"$nulls":8},"(正面)"]
[null,"申請日期：____年____月____日",null,null,null,"收字第",null,null,null,"號"]
[]
["產品\n名稱","中文"]
[null,"英文"]
["申請者","商號名稱"]
[null,"商號地址"]
["申請書","序號","項目",null,null,null,"自行審核","初審","欠缺內容","複審","欠缺內容"]
[null,1,"申請書正本1份。",null,null,null,"□","□",null,"□"]
[null,2,"填妥申請書各欄，包括名稱(中、英文)、包裝、劑型、製造廠名稱、廠址、申請商號欄；並加蓋「公司」及「負責人」印章。",null,null,null,"□","□",null,"□"]
[null,3,"擬定化粧品中文名稱：貨品之命名須使消費者易於明白、理解者為原則，如xx冷燙液、xx染髮液、或xx面霜等，虛偽誇大或涉及醫療效能之言詞，均不得使用。",null,null,null,"□","□",null,"□"]
[null,4,"化粧品外文名稱：其命名以中文名稱之音譯或意譯為原則。",null,null,null,"□","□",null,"□"]
[null,5,"包裝：參照化粧品包裝限量表，應填寫其包裝限量以下及包裝容器(如500公撮以下瓶裝、500公克以下盒裝等)。",null,null,null,"□","□",null,"□"]
[null,6,"劑型：參照「化粧品製造工廠設廠標準」中劑型之分類填寫(如粉劑、液劑、乳劑、油劑、油膏劑、噴霧劑等)。",null,null,null,"□","□",null,"□"]
[null,7,"製造廠名稱與地址：依照所附經濟部工廠登記文件中製造廠名稱及地址填寫。",null,null,null,"□","□",null,"□"]
[null,8,"申請商號及地址：依照所附公司或商號登記文件中登載之名稱及地址填寫。",null,null,null,"□","□",null,"□"]
[null,9,"全處方：應有全處方包括主成分、賦形劑、防腐劑、色素、香料之成分名稱及含量之記載，並以英文名稱表示之，不得使用縮體名稱，其含量須用重量(w/w%)或容量(w/v%)百分比表示。",null,null,null,"□","□",null,"□"]
[null,10,"用途、用法用量、注意事項：應填寫各欄，用途欄應記載相關於特定用途化粧品品項類別，例如：防曬、隔離紫外線(防曬劑)、染髮(染髮劑)、燙髮（燙髮劑)等。",null,null,null,"□","□",null,"□"]
["須檢附資料或證件",1,"證照粘貼表一份："]
[null,null,"1.粘貼公司或商號登記文件影本(核對申請商號及地址)、經濟部工廠登記文件影本(核對製造廠名稱及地址)、監製人員文件影本(核對負責監製者名字、藥師證書號與地址，或專業技術人員畢業證書影本、在職證明、職前訓練證明文件影本)。",null,null,null,"□","□",null,"□"]
[null,null,"2.以許可證持有者申請查驗登記時，應加附雙方簽訂之委託製造書面契約文件一份。 ",null,null,null,"□","□",null,"□"]
[null,2,"標籤仿單粘貼表二份。"]
[null,null,"1.粘貼產品之標簽、仿單(說明書)或包裝之設計稿。",null,null,null,"□","□",null,"□"]
[null,null,"2.外包裝上應以英文或中文標示產品所含之全部成分名稱。(依全成分標示規定)",null,null,null,"□","□",null,"□"]
[null,null,"3.標籤、仿單(說明書)，或包裝上應刊載廠名、地址、品名、許可證字號、成分、用途、用法、重量或容量、批號或出廠日期、保存方法及保存期限(指定公告者)、主成分名稱及含量、使用時注意事項等項目。",null,null,null,"□","□",null,"□"]
[null,3,"GMP證明文件",null,null,null,"□","□",null,"□"]
[]
[{"$nulls":10},"(反面)"]
["茲向\n衛生福利部切結本申請商以上所填列資料均屬實無誤，若有不實、造假或違背相關法規之情事，甘願接受吊銷本品許可證或公告註銷及禁售產品等處分，並負法律上一切責任。品質、效能宣稱之管理及留廠備查之檢驗規格相關資料，由具切結申請商完全負責。"]
[]
[]
[]
[]
[]
["具切結申請商名稱：",{"$nulls":5},"蓋章"]
["負責人：",{"$nulls":5},"蓋章"]
[]
["中華民國       年       月       日"]
[]
["附註","本表請以中／英文打字填表，且正、反面一併列印。"]
[]
["給證日期","       年       月        日",null,null,null,"許可字號",null,"                 字第              號"]
[]
["※備註"]
{"$rows_empty":21}
["承辦人員"]

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