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MoCRA Updates: FDA Releases the Final Guidance on Cosmetic Facility Registration and Product Listing for MoCRA

The final Guidance covers term explanations, responsible entities for application submission, necessary dossiers, submission methods, submission deadlines, etc. The final Guidance adds the instructions for FEI application, the definition of “U.S. agent”, and a new FAQ attachment comprising 19 FAQs.

Following a public consultation on the draft Guidance on Registration and Listing of Cosmetic Product Facilities and Products on August 7, 2023, the U.S. Food and Drug Administration (FDA) officially issued the final Guidance on December 18, 2023. This comprehensive document offers instructions for submitting cosmetic facility registrations and product listings to the FDA. To be specific, the document covers term explanations, responsible entities for application submission, necessary dossiers, submission methods, submission deadlines, and more.

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