China Instructions for Cosmetic Registration and Notification Dossiers (Draft for Comments)

China Instructions for Cosmetic Registration and Notification Dossiers (Draft for Comments)

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Basic Information
  • Translated By:ChemLinked
  • Release Date:Aug 28, 2020
    Implement Date:/
     
  • Pages:210
    Format:Electronic Edition (Adobe PDF)
    Language:EN&CN
  • Created On:Sep 08, 2020
    Last Updated On:Sep 08, 2020
     
Background

On July 21, China Ministry of Justice opened a public consultation on the Administrative Measures on Cosmetic Registration. On August 28, 2020, China National Institutes for Food and Drug Control (NIFDC) opened a public consultation on the draft Instructions for Cosmetic Registration and Notification Dossiers, specifying the documentation requirements for the application, modification, renewal, and cancellation of cosmetic registration/notification.

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Contents

Chapter I Basic Requirements

Chapter II Form Requirements

Chapter III User Permission Activation and Maintenance

Chapter VI Requirements for Registration Renewal, Cancellation and Other Matters

Chapter VII Supplementary Provisions

Attachment 1 Requirements for Document Items to be Submitted by Users

Attachment 2 Registrant/Notifier Information Form

Attachment 3 Quality Management System Overview

Attachment 4 Adverse Reaction Monitoring and Evaluation System Overview

Attachment 5 Domestic Responsible Person Information Form

Attachment 6 Authorization and Commitment Letters of Domestic Responsible Person for Cosmetics Registration and Notification

Attachment 7 Production Enterprise Information Form

Attachment 8 General Review and Maintenance Information Form

Attachment 9 Actual Production Site Review and Maintenance Information Form

Attachment 10 User Permission Cancellation Information Form

Attachment 11 Cosmetics Registration and Notification Information Form

Attachment 12 Example of Formula Table and Filling Instruction

Attachment 13 Cosmetic Product Executive Standard (Text Format) 

Attachment 14 Example of Cosmetic Product Executive Standard

Attachment 15 Cosmetic Administrative Licensing/Notification Modification Application Form

Attachment 16 Application Form for Cosmetic Product Registration Renewal

Attachment 17 Example of Commitment Report on Registration Renewal Self-Testing

Attachment 18 Application Form for Termination of Cosmetics Administrative Licensing

Attachment 19 Application Form for Withdrawal of Cosmetics Administrative Licensing

Attachment 20 Application Form for Cancellation of Cosmetic Administrative Licensing (Notification)