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Guidelines for Control of Cosmetic Products in Malaysia (2022)

Local Title
Guidelines for Control of Cosmetic Products in Malaysia (2022)
Country/Region
Malaysia
Competent Authority
National Pharmaceutical Regulatory Agency
Type
Regulation
Status
In force
Release Date
2022-07-19
Implementation Date
2022-08-01

This Guidelines for Control of Cosmetic Products in Malaysia shall serve as reference for notification process including quality control, inspection and post-market surveillance activities of cosmetics. This document will replace the Guidelines for Control of Cosmetic Products in Malaysia First Revision 1st February 2017.

The content of this guideline is adapted from the ASEAN Cosmetic Directive (ACD). This guideline shall be read in conjunction with the current laws and regulations together with other relevant legislations, where applicable, governing cosmetics for human use in Malaysia, which include but are not limited to the following:

  • Sale of Drugs Act 1952

  • Control of Drugs and Cosmetics Regulations 1984

  • Dangerous Drugs Act 1952

  • Poisons Act 1952

  • Medicines (Advertisement & Sale) Act 1956

  • Patents Act 1983

  • Wildlife Conservation Act 2010 (Laws of Malaysia Act 716)

  • International Trade in Endangered Species Act 2008 (Act 686)

  • Medical Device Act 2012

  • Trade Descriptions Act 2011

This guideline contains 7 main sections, 25 appendices. The main sections are:

  • Section 1: General Overview

  • Section 2: Cosmetic Notification

  • Section 3: Regulatory Requirements for Cosmetic Product

  • Section 4: Post Market Surveillance

  • Section 5: Regulatory Action

  • Section 6: Notification Withdrawal

  • Section 7: Notification Exemption

The written laws shall take precedence over this guideline in any event of discrepancy. The scope of this guideline includes information relating to:

  • Submission of cosmetic notification through the NPRA Quest online system.

  • Regulatory requirements for cosmetic products

  • Post market surveillance activities

Cosmetic Notification Holder (CNH) shall understand the content of this guideline and the governing legislations before submission of a cosmetic notification is made.

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