구분 | 미주 | 등록일 | 24.02.21 | ||||
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제목 | 미국 FDA, MoCRA : 시설 등록 및 제품 리스팅 가이던스 최종판 발표 (Guidance for Industry: Registration and Listing of Cosme | ||||||
첨부파일 |
Guidance-Cosmetics-RegistrationListing-12142023.pdf Guidance-Cosmetics-RegistrationListing-12142023 KOR 1.1.pdf | ||||||
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MoCRA와 관련하여, 2023년 12월 19일, 미국 FDA에서는 "시설 등록 및 제품 리스팅 : 산업계를 위한 가이던스 최종판"을 발표하였습니다. Guidance for Industry: Registration and Listing of Cosmetic Product Facilities and Products
GUIDANCE DOCUMENT Guidance for Industry: Registration and Listing of Cosmetic Product Facilities and ProductsDECEMBER 2023Download the Final Guidance Document Read the Federal Register Notice
This guidance provides recommendations and instructions to assist persons submitting cosmetic product facility registrations and product listings to FDA. This guidance document explains, among other things:
FDA's guidance documents, including this guidance, do not establish legally enforceable responsibilities. Instead, guidances describe our current thinking on a topic and should be viewed only as recommendations, unless specific regulatory or statutory requirements are cited. The use of the word should in FDA guidances means that something is suggested or recommended, but not required. NOTE: Appendix B of this guidance that describes frequently asked questions and answers is being distributed for comment purposes only. Although you can comment on any guidance at any time (see 21 CFR 10.115(g)(5)), to ensure that FDA considers your comment on the Appendix B before we begin work on the final version of Appendix B, submit either electronic or written comments on this document by January 18, 2024. You may submit comments electronically on Regulations.gov to docket folder FDA-2023-D-1716. See the Federal Register notice for additional information on commenting. Related Resources
Announcements
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이전글 | 유럽 화장품 규정 : EU Cosmetic Regulation Regulation (EC) No 1223/2009 | ||||||
다음글 | 미국 FDA. MoCRA의 Cosmetic Direct 사용자 가이드(영어 원문, 국문번역본) |
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