Regulations on Notification of Cosmetics in Malaysia


On August 2022, the Malaysian government issued Guidelines for Control of Cosmetic Products in Malaysia-Second Edition. This document shall serve as a reference for the notification process including notification, regulatory requirements, quality control, inspection, and post-market surveillance activities of cosmetics. This article is an excerpt of the procedure and requirement of notification for cosmetics in Malaysia.


1.1      Introduction

 Cosmetic products in Malaysia are regulated under the Control of Drugs and Cosmetic Regulations (CDCR) 1984 which was promulgated under the Sale of Drugs Act 1952.

In agreement with the harmonization of cosmetic regulation through the ASEAN Cosmetic Directive (ACD), cosmetic products in Malaysia are controlled through a notification procedure starting from 1 January 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 declarations and/or products found to be non-compliant with the stipulated regulations and guidelines.

Under the CDCR 1984, Regulation 18A (1): No person shall manufacture, sell, supply, import, or possesses any cosmetics unless the cosmetic is a notified cosmetic. It is an offense for anyone to conduct such activities without prior notification to the DPS.



 2.1 Who Shall Submit for Cosmetic Notification

The CNH is responsible to notify the DPS prior to manufacturing, selling, supplying, importing, or possessing any cosmetic product.


2.2 Responsibility of the Cosmetic Notification Holder

 CNH is responsible to ensure that:

a) All transactions with NPRA shall be carried out by CNH’s appointed person(s).

b) Notified product meets all stipulated regulations and guidelines for cosmetic products.

c) Product Information File (PIF), including updated information/documents on product quality, safety and claimed benefit, is available and accessible upon request.

d) If and when directed by NPRA for product recall, CNH must ensure all affected cosmetic products are recalled from the market and discontinued from selling or supplying the product. Product distribution records must be properly kept for recall purposes.

e) Change(s) to notified product particulars is submitted accordingly.

f) Manufacturer (and assembler, where applicable) of the cosmetic product is compliant with the current Good Manufacturing Practice (cGMP).

g) In the incidence of a serious adverse event, CNH shall report to NPRA appropriately.

h) Particulars given for product notification are truthful where all data and information of relevance to the notification have been provided.

i) Each consignment continues to meet all legal requirements and conforms to the standards and specifications declared for the product. 

j) When a product fails to conform to any of the standards or specifications declared for the product, CNH cannot place reliance on the acceptance of the product notification in any legal proceedings. 

k) Correspondence details such as the company’s name, address, contact person, telephone number, fax number, and email shall be kept updated. 

l) Cessation of the authorization of the CNH shall be informed to the NPRA in writing.

m) Any decision to withdraw the notification of a product shall be informed to the NPRA, with reasons. 


2.3 Submission of Notification

 All submissions for notification shall be done online through the NPRA Quest system via NPRA’s website at


2.3.1  Quest Membership Registration

 A CNH must first register for a Quest membership. A detailed guide for Quest membership registration is available on NPRA’s website. CNH may also refer to the Frequently Asked Questions (FAQ) section on Quest System at NPRA’s website for more information.

For information on charges and validity of the membership, please refer to Annex I, part 3: Charges for Quest Membership.

The CNH shall be responsible for any act of fraudulence or misuse of Quest membership.

The NPRA reserves the right to approve or reject any application for the Quest membership.


2.3.2 Notification of Cosmetic Products

 For online submission of notification of cosmetic products, CNH must complete the notification form in the Quest system for each cosmetic product and variant, if any, and proceed with the payment to the NPRA.

Step-by-step guidance on online notification submission is described further in Annex I, part 4: Manual for Quest3+ Online Submission for Cosmetic Notification

A general workflow of a notification process is shown in Figure 1.

Figure 1: Workflow of a notification process


2.4 Language

Any document and material submitted to NPRA must be in Bahasa Malaysia or English. Translated versions from other languages must be endorsed or authorized.


2.5 Privacy Markings

All Information submitted to the NPRA is deemed confidential, even though it is not marked as such by the CNH.


2.6  Fee

The processing fee for notification of a cosmetic product is RM50.00 for each product (and variant, if any).

The processing fee for renewal of notification of a cosmetic product is also RM50.00 for each product (and variant, if any).

Any payment made shall NOT BE REFUNDABLE once the application has been submitted and payment is confirmed. Please refer to Annex I, part 4: Manual for Quest3+ Online Submission for Cosmetic Notification for acceptable modes of payment.


2.7 Notification Validity Period

The notification of a cosmetic product shall be valid for 2 years. The renewal should be done no later than 1 month prior to notification expiry.


2.8 Manufacture or Importation of Product

CNH may manufacture or import the cosmetic product upon receipt of the authorization given in the Notification Note from the DPS. CNH may generate the Notification Note immediately from the QUEST system after confirmation of payment by NPRA subject to meeting all notification requirements.


2.9 Changes in Notification Particulars

Any subsequent changes to the particulars of the notified cosmetic product must be submitted to the NPRA. There are two types of changes:


Type 1 change:

  • Changes that only require amendments to the current notification. No charge is imposed and the notification number remains the same.

Type 2 change:

  • Changes that require a new notification and is subjected to RM 50.00 processing fee. A new notification number will be issued to the product.

Please refer to Annex I, part 5 for the List of Types of Changes for Notified Product


2.10 Notification Number

The notification number is unique for each product and its variants (if any) in the format below:

NOTyymmxxxxxK (y: year, m: month, x: serial number)

CNH is responsible to ensure the maintenance of valid notification numbers for products in the market. The existing notification number will be retained for a product notification that has been renewed prior to the expiry date. A new notification number will be generated for a product that is not renewed within the given timeline and for a product that has undergone changes requiring new notification.


2.11   Certificate of Free Sale

A certificate of free sale (CFS) serves as a document that states that the product can be freely sold in Malaysia. The certificate is not a mandatory requirement. As such, it will only be issued by the NPRA upon request by the CNH who wishes to export their notified cosmetic product to another country that requires the certificate.

The application for CFS can only be made through online submission by the CNH via the Quest system and a fee of RM50.00 will be charged for each copy of the certificate. CFS for a product and variant can be combined in one certificate provided that the latter is notified as a variant of the main product.



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