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Laws & Regulations Database of The Republic of China (Taiwan)

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Title: Standards of Administrative Fees for Cosmetics CH
Amended Date: 2019-05-28
Category: Ministry of Health and Welfare(衛生福利部)
Article 1
These Standards are adopted pursuant to the provisions of Article 30 of the Cosmetic Hygiene and Safety Act (the Act) and Article 10 of the Charges and Fees Act.
Article 2
The standards for charging the review fees, certificate fees, and inspection fees for cosmetics notification, applications for registration, applications for inspection of compliance with the cosmetic Good Manufacturing Practice Regulations are as follows:
1. Cosmetics notification
(1) The review fee charged for cosmetics notification shall be NT$600 per application.
(2) The review fee charged for modification of cosmetics notification shall be NT$600 per application.
(3) The review fee charged for extension of cosmetics notification shall be NT$600 per application.
2. Applications of animal testing for the safety assessment of cosmetics or cosmetic ingredients
(1) The review fee charged for animal testing for the safety assessment of cosmetics or cosmetic ingredients, NT$40,000 shall be charged per application.
(2) For reissuing or renewing approved documents of animal testing for the safety assessment of cosmetics or cosmetic ingredients, NT$4,000 shall be charged per application.
3. Applications for registration of specific purposes cosmetics
(1) The review fee charged for registering new specific purposes cosmetics shall be NT$36,000 per application.
(2) The review fee charged for registering specific purposes cosmetics shall be NT$12,000 per application.
(3) The review fee to register changes of specific purposes cosmetics (product name, packaging, usage, business applicant, or manufacturer) shall be NT$3,500 per application.
(4) The review fee to register modification of specific purposes cosmetics (ingredient or item) shall be NT$5,000 per application.
(5) The review fee charged for registering license extension of specific purposes cosmetics shall be NT$3,500 per application.
(6) For reissuing lost licenses, approved documents of label or package insert for specific purposes cosmetics, NT$3,500 shall be charged per application.
(7) The review fee charged for regulatory determination of the property of cosmetic products shall be NT$2,500 per application.
(8) The review fee charged for importing cosmetics for specific purposes and related products for registration or research, NT$3,000 shall be charged per application.
(9) The fee charged for authorizing a license of specific purposes cosmetics shall be NT$4,000 each.
(10) The fee charged for a license shall be NT$1,500 each.
4. Applications for inspection of compliance with the cosmetic 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 document review of NT$60,000 and on-site inspection of NT$540,000.
(3) For changes of approved documents of cosmetic 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 sale certificates, and cosmetics manufacturing certificates shall be NT$2,000 per application.
(2) For Chinese cosmetics manufacturing and sale certificates, imported cosmetics sale certificates or cosmetics manufacturing certificates, NT$1,500 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 sale certificates or cosmetics manufacturing certificates, NT$1,500 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.
Article 3
The on-site inspection fee for auditors and experts set forth in Item 2, Subparagraph 4 of the preceding article shall apply mutatis mutandis to the Directions for the Overseas Travel Allowance Disbursement, and shall be charged from the audited unit by the central competent authority.
Article 4
The Standards shall be effect on July 1, 2019.
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