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Cosmetic Products

A cosmetic product shall mean “any substance or preparation intended to be placed in contact with various external parts of the human body (epidermis, hair system, nails, lips and external genital organs) or with teeth and the mucous membranes of the oral cavity, with a view exclusively or mainly to cleaning them, perfuming them, changing their appearance and/or correcting body odours and/or protecting them or keeping them in good condition”.

Guidelines For Control Of Cosmetic Products In Malaysia

1. 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.

 

2 : Cosmetic Notification

Who Shall Submit for Cosmetic Notification, Responsibility of the CNH,Submission of Notification etc 

6. 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 

3.0 Regulatory Requirements For Cosmetics

Product Particulars, Safety Requirements, Cosmetic Ingredients, Labelling Requirements, Cosmetic Claims etc 

7. Notification Exemption

Market Sampling, In–House Evaluation, FEO or for Re-Exporting, In Transit 

4. Post Market Surveillance Programme

Post Market Surveillance Activities, Product Sampling Requirements

8. Certificate Of Free Sale

CFS serves as document which state that the product can be freely sold in Malaysia 

5. Regulatory Action

Rejection of Notification Submission, Cancellation of Notification Note & Punitive Action/Penalty

9. Halal

Halal logo may be used voluntarily on a notified cosmetic product 

National Pharmaceutical Regulatory Agency (NPRA)
Lot 36, Jalan Universiti, 46200 Petaling Jaya, Selangor, Malaysia.
  • Email: npra@npra.gov.my
  • Phone: +603-7883 5400
  • Fax: +603-7956 2924, +603-7956 7075

DISCLAIMER

The Government of Malaysia and the National Pharmaceutical Regulatory Agency are not responsible for any loss or damage caused by the usage of any information obtained from this website.

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  • Last Modified: Friday 14 December 2018, 08:46:08.
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