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Guidelines For Control Of Cosmetic Products In Malaysia
Introduction
Cosmetic products in Malaysia are regulated under the Control of Drugs and Cosmetic Regulations (CDCR) 1984 which were promulgated under the Sale of Drugs Act 1952.
In agreement with the harmonisation of cosmetic through the ASEAN Cosmetic Directive (ACD), cosmetic products in Malaysia are controlled through notification procedure starting from 1stJanuary 2008. The CNH is required to COMPLY with all requirements stated in this guideline and to make a declaration upon notification to the Director of Pharmaceutical Services (known as DPS) through National Pharmaceutical Regulatory Agency (NPRA). Regulatory action will be taken in the event of false declaration and/or product found to be non- compliant to the stipulated regulations and guidelines.
Under the CDCR 1984, Regulation 18A (1): No person shall manufacture, sell, supply, import, possesses any cosmetics unless the cosmetic is a notified cosmetic. It is an offence for anyone to conduct such activities without prior notification to the DPS.
Cosmetic Notification
Who Shall Submit for Cosmetic Notification, Responsibility of the CNH,Submission of Notification etc
Regulatory Action
Rejection of Notification Submission, Cancellation of Notification Note & Punitive Action/Penalty
Regulatory Requirements For Cosmetics
Product Particulars, Safety Requirements, Cosmetic Ingredients, Labelling Requirements, Cosmetic Claims etc
Notification Withdrawal
CNH shall inform the NPRA of their decision to withdraw the notification of any cosmetic product before the end of its validity stating the reason for the decision
Post Market Surveillance Programme
Post Market Surveillance Activities, Product Sampling Requirements
Notification Exemption
Market Sampling, In–House Evaluation, FEO or for Re-Exporting, In Transit