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Standards of Administrative Fees for Cosmetics - Article 2

Standards of Administrative Fees for Cosmetics|第 2 條|Food and Drug Administration|Regulation|In Force

衛生福利部|v1.0

Effective Date: 2026-07-01|Last Amended: 2025-11-06

Content

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.

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