On November 9, 2023, Indonesia released the amended draft of the Regulation for Cosmetics Adverse Reaction Monitoring for public consultation. This Regulation aims to provide clarity on the requirements for reporting cosmetics adverse reactions. It defines the adverse reactions, specifies the obligations of notifiers, and outlines the approaches for reporting adverse reactions.
Monitoring cosmetics adverse reactions are activities that include recording, data collection, reporting, evaluation, prevention and follow-up on effects in the form of undesirable events that arise due to/during the use of cosmetics.
Main Content
General Requirements
Application
Reporting Procedures
Documentation
Administrative Sanctions
Closing
Annex I Thirty Hair Dyeing Agents
Annex II Quick Reporting Form
Annex III Monitoring Reporting Form for Cosmetic Adverse Reactions
Instructions for Filling Monitoring Reporting Form for Cosmetic Adverse Reactions
Annex IV Recapitulation Table of Monitoring Results of Cosmetic Adverse Reactions
Instructions for Filling the Recapitulation Table of Monitoring Results of Cosmetic Adverse Reactions