Cosmetic Compliance
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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
Document
Language Source Title Access
EN
Official Guidelines for Control of Cosmetic Products in Malaysia 2022
EN
Official Annex I, Part 1 Illustrative List of cosmetic Products By Categories
EN
Official Annex I, Part 2 Non-Permissible Product Name for Cosmetic Product
EN
Official Annex I, Part 3 Charges for Quest Membership
EN
Official Annex I, Part 4 Manual for Quest3+ Online Submission for Cosmetic Notification
EN
Official Annex I, Part 5 List of Types of Changes for Notified Product
EN
Official Annex I, Part 6 Guideline for Safety Assessment of Cosmetic Products
EN
Official Annex I, Part 7 Cosmetic Labeling Requirements
EN
Official Annex I, Part 8 Guideline for Cosmetic Claims
EN
Official Annex I, Part 9 List of Guidelines for Products with Specific Requirements
EN
Official Annex I, Part 9(i) Guideline for Sunscreen Product
EN
Official Annex I, Part 9(ii) Guideline for Hand Sanitizer Product
EN
Official Annex I, Part 9(iii) Guideline for Antibacterial Hygiene Wash Product
EN
Official Annex I, Part 10 Guideline for Cosmetic Advertisement
EN
Official Annex I, Part 11 Guideline for Cosmetic Good Manufacturing Practice
EN
Official Annex I, Part 12 List of Equivalent Cosmetic GMP Guidelines
EN
Official Annex I, Part 13 Guideline for Product Information File (PIF)
EN
Official Annex I, Part 14 Heavy Metal and Microbiological Test Limit for Cosmetic Product
EN
Official Annex I, Part 15 Guide Manual for Adverse Event Reporting
EN
Official Annex I, Part 16 Guidance for Industry – Reporting and Recall of Cosmetic Product
EN
Official Annex II List of Substances Which Must Not Form Part of the Composition of Cosmetic Products
EN
Official Annex III List of Substances Which Cosmetic Products Must Not Contain Except Subject to Restrictions and Conditions Laid Down
EN
Official Annex IV, Part 1 List of Colouring Agents Allowed for Use in Cosmetic Products
EN
Official Annex V List of Excluded From the Scope of the Directive
EN
Official Annex VI List of Preservatives Which Cosmetic Products May Contain
EN
Official Annex VII List of UV Filters Which Cosmetic Products May Contain
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Guidelines for Control of Cosmetic Products in Malaysia (2022)
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Summary

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.

History
2022-07-19
Guidelines for Control of Cosmetic Products in Malaysia (2022)
In force
Release Date: 2022-07-19
Implementation Date : 2022-08-01
2022-07-18
In force
Release Date: 2022-07-18
Implementation Date : 2022-07-18
2022-07-06
2021-12-13
2021-09-29
2021-05-07
2017-02-01
In force
Release Date: 2017-02-01
Implementation Date : 2017-02-01
Noteworthy Information