Standards of Administrative Fees for Cosmetics Article 2
The standards for charging review fees, certificate fees, and inspection fees for cosmetics notification and applications for inspection of compliance with the Cosmetics Good Manufacturing Practice Regulations are as follows:1. Cosmetics notification:(1) The review fee charged for cosmetics notification shall be NT$800 per application.(2) The review fee charged for amendments to a cosmetics notification shall be NT$700 per application.(3) The review fee charged for amendments to multiple cosmetics notifications shall be NT$700 for up to 30 notifications; an additional NT$100 shall be charged for each additional 30 notifications; any number of notifications fewer than 30 shall be counted as 30.(4) The review fee charged for extension of cosmetics notification shall be NT$600 per application.2. Applications for animal testing for the safety assessment of cosmetics or cosmetics ingredients:(1) The review fee charged for animal testing for the safety assessment of cosmetics or cosmetics ingredients shall be NT$40,000 per application.(2) The review fee charged for amendments to an approved case shall be NT$10,000 per application.(3) For reissuance or replacement of approval document for animal testing for the safety assessment of cosmetics or cosmetics ingredients, NT$4,000 shall be charged per application.3. The review fee charged for inquiry regarding the classification of cosmetic products shall be NT$3,500 per application.4. Applications for inspection of compliance with the Cosmetics Good Manufacturing Practice Regulations:(1) For inspections or subsequent inspections of establishment, relocation, or expansion of manufacturing facilities for domestic cosmetics, new forms of cosmetics, or processed items, NT$60,000 shall be charged per application.(2) For on-site inspections or subsequent inspections of manufacturing facilities for foreign cosmetics, NT$600,000 shall be charged per application, including documents review of NT$60,000 and on-site inspection of NT$540,000.(3) For amendments to approval documents of cosmetics Good Manufacturing Practice, NT$6,000 shall be charged per application.5. Cosmetics certificates and approval letters:(1) The document review fee charged for cosmetics manufacturing and sale certificates, imported cosmetics sales certificates, and cosmetics manufacturing certificates shall be NT$2,800 per application.(2) For Chinese cosmetics manufacturing and sale certificates, imported cosmetics sales certificates or cosmetics manufacturing certificates, NT$1,800 shall be charged for an original, and NT$200 shall be charged for a copy.(3) For English cosmetics manufacturing and sale certificates, imported cosmetics sales certificates or cosmetics manufacturing certificates, NT$1,800 shall be charged for an original, and NT$200 shall be charged for a copy.(4) NT$1,500 shall be charged for a Chinese cosmetics GMP compliance certificate.(5) NT$1,500 shall be charged for an English cosmetics GMP compliance certificate.(6) For reissuing lost approved documents of cosmetics GMP compliance, NT$1,800 shall be charged per application.6. Applications for the approval of human cell-derived exosomes for use in cosmetics:(1) The review fee charged for human cell-derived exosomes for use in cosmetics shall be NT$100,000 per application.(2) The review fee charged for amendments to an approved case shall be NT$10,000 per application.(3) For reissuance or replacement of approval document for human cell-derived exosomes for use in cosmetics, NT$4,000 shall be charged per application.Applications under Subparagraph 5, Items (1) through (3) of the preceding paragraph shall be limited to ten products per application.
中文原文 化粧品行政規費收費標準第2條
化粧品產品登錄及化粧品優良製造準則符合性檢查之相關審查費、證書費及查核費之收費標準如下：
一、化粧品登錄：
（一）化粧品登錄，每件收取新臺幣八百元。
（二）登錄資料單筆變更，每筆收取新臺幣七百元。
（三）登錄資料多筆變更，三十筆以下者，收取新臺幣七百元；超過三十筆者，每超過三十筆加收新臺幣一百元；不足三十筆者，以三十筆計算。
（四）登錄資料展延，每件收取新臺幣六百元。
二、化粧品或化粧品成分安全性評估申請動物試驗：
（一）化粧品或化粧品成分安全性評估申請動物試驗審查費，每件收取新臺幣四萬元。
（二）化粧品或化粧品成分安全性評估申請動物試驗變更審查費，每件收取新臺幣一萬元。
（三）化粧品或化粧品成分安全性評估申請動物試驗許可文件補發或換發，每件收取新臺幣四千元。
三、化粧品產品屬性管理查詢審查費，每件收取新臺幣三千五百元。
四、化粧品優良製造準則符合性檢查：
（一）國產化粧品製造場所之新設、遷移、擴建或增加劑型、加工項目之檢查，或其後續檢查，每件收取新臺幣六萬元。
（二）國外化粧品製造場所之現場檢查及其後續檢查，每件收取新臺幣六十萬元，其收費含文件審查新臺幣六萬元及實地查核新臺幣五十四萬元。
（三）化粧品優良製造核定文件登載事項之變更，每件收取新臺幣六千元。
五、化粧品相關證明書及備查函：
（一）化粧品產銷證明書、輸入化粧品銷售證明書、化粧品製造證明書申請案之書面審查，每件收取新臺幣二千八百元。
（二）中文化粧品產銷證明書、輸入化粧品銷售證明書或化粧品製造證明書，正本每份收取新臺幣一千八百元，副本每份收取新臺幣二百元。
（三）英文化粧品產銷證明書、輸入化粧品銷售證明書或化粧品製造證明書，正本每份收取新臺幣一千八百元，副本每份收取新臺幣二百元。
（四）中文化粧品優良製造證明書，每份收取新臺幣一千五百元。
（五）英文化粧品優良製造證明書，每份收取新臺幣一千五百元。
（六）化粧品優良製造核定文件遺失補發，每件收取新臺幣一千八百元。
六、申請源自人體細胞之外泌體使用於化粧品：
（一）個案審查費，每件收取新臺幣十萬元。
（二）變更審查費，每件收取新臺幣一萬元。
（三）審查許可文件補發或換發，每件收取新臺幣四千元。
前項第五款第一目至第三目之申請案，每件以十項產品為限。
一、化粧品登錄：
（一）化粧品登錄，每件收取新臺幣八百元。
（二）登錄資料單筆變更，每筆收取新臺幣七百元。
（三）登錄資料多筆變更，三十筆以下者，收取新臺幣七百元；超過三十筆者，每超過三十筆加收新臺幣一百元；不足三十筆者，以三十筆計算。
（四）登錄資料展延，每件收取新臺幣六百元。
二、化粧品或化粧品成分安全性評估申請動物試驗：
（一）化粧品或化粧品成分安全性評估申請動物試驗審查費，每件收取新臺幣四萬元。
（二）化粧品或化粧品成分安全性評估申請動物試驗變更審查費，每件收取新臺幣一萬元。
（三）化粧品或化粧品成分安全性評估申請動物試驗許可文件補發或換發，每件收取新臺幣四千元。
三、化粧品產品屬性管理查詢審查費，每件收取新臺幣三千五百元。
四、化粧品優良製造準則符合性檢查：
（一）國產化粧品製造場所之新設、遷移、擴建或增加劑型、加工項目之檢查，或其後續檢查，每件收取新臺幣六萬元。
（二）國外化粧品製造場所之現場檢查及其後續檢查，每件收取新臺幣六十萬元，其收費含文件審查新臺幣六萬元及實地查核新臺幣五十四萬元。
（三）化粧品優良製造核定文件登載事項之變更，每件收取新臺幣六千元。
五、化粧品相關證明書及備查函：
（一）化粧品產銷證明書、輸入化粧品銷售證明書、化粧品製造證明書申請案之書面審查，每件收取新臺幣二千八百元。
（二）中文化粧品產銷證明書、輸入化粧品銷售證明書或化粧品製造證明書，正本每份收取新臺幣一千八百元，副本每份收取新臺幣二百元。
（三）英文化粧品產銷證明書、輸入化粧品銷售證明書或化粧品製造證明書，正本每份收取新臺幣一千八百元，副本每份收取新臺幣二百元。
（四）中文化粧品優良製造證明書，每份收取新臺幣一千五百元。
（五）英文化粧品優良製造證明書，每份收取新臺幣一千五百元。
（六）化粧品優良製造核定文件遺失補發，每件收取新臺幣一千八百元。
六、申請源自人體細胞之外泌體使用於化粧品：
（一）個案審查費，每件收取新臺幣十萬元。
（二）變更審查費，每件收取新臺幣一萬元。
（三）審查許可文件補發或換發，每件收取新臺幣四千元。
前項第五款第一目至第三目之申請案，每件以十項產品為限。