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End-to-End service provider for cosmetics in Malaysia
A trusted regulatory consultant for successful commercialization of cosmetics in Malaysia.
Artixio is a leading consulting company with presence in over 100+ countries, helping our clients with effective regulatory strategies to successfully commercialize their products in the Malaysian market. With our regulatory experts team, we offer complete support right from product development up to its successful launch and then post-approval maintenance in compliance with Malaysian regulatory requirements.
Overview of Cosmetics in Malaysia
As per Malaysia, a cosmetic product is 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 or correcting body odours or protecting them or keeping them in good condition.
Cosmetic products in Malaysia are regulated under the Control of Drugs and Cosmetic Regulations (CDCR) 1984 promulgated under the Sale of Drugs Act 1952.
Cosmetic products in Malaysia are controlled through notification procedure, and it is considered as an offence to manufacture, sell, supply, import, possess any cosmetic if it is not a notified cosmetic.
The Cosmetic Notification Holder (CNH) must comply with the requirements of Malaysian guidelines for cosmetic products and must make a declaration upon notification to the Director of Pharmaceutical Services (DPS) through National Pharmaceutical Regulatory Agency (NPRA).
Artixio provides a step-to-step guidance for all submission for notification of the cosmetics in Malaysia, and it is done through the Online QUEST system via NPRA’s website http://npra.moh.gov.my., in compliance with the NPRA regulatory requirements.
Process for Cosmetic notification in Malaysia is as follows:
A notification number is unique for each product and its variant (if any). CNH is responsible for ensuring the maintenance of valid notification number for products in the market. Existing notification number is retained for product notification renewed before the expiry date. For products that are not renewed within the given timeline and products with changes requiring new notification, a new notification number will be generated.
Fees
The processing fee for notification of a cosmetic product is RM 50.00 for each product (and variant, if any).
(RM: Malaysian ringgit)
Validity period
The validity period for notification of a cosmetic product is 2 years. The renewal should be done no later than 1 month prior to notification expiry.
Certificate of Free Sale (CFS)
- A CFS is a document which states that the product can be freely sold in Malaysia. It is not a mandatory requirement.
- It will be issued by the NPRA upon request by the CNH willing to export their notified cosmetic product to another country that requires the certificate.
Artixio offers following services for cosmetic products in Malaysia
- Stepwise guidance for QUEST registration
- Advice on data requirements
- Strategies to get the cosmetic product successfully notified
- Support throughout the product commercialization journey
- Post-approval maintenance of the product
Why Artixio
Global experts with decades of experience in successful product commercialization
Evidence based solutions
Strategies by reducing time to market entry of the product
Provide insights to make a product stand out in the global market
Regional expertise in compliance with the health authority requirements
FAQs
Which is language is required for documents submission for cosmetic products to NPRA Malaysia?
Documents submitted to NPRA Malaysia must be Bahasa Malaysia or English, and translated version from other languages must be endorsed or authorised.
What is the processing fees for renewal of notification of a cosmetic product in Malaysia?
The processing fees for renewal of notification of a cosmetic product is RM 50.00 for each product (and variant, if any).
How to submit changes to an existing cosmetic product notification in Malaysia?
Any subsequent change to the particulars of a notified cosmetic product must be submitted to NPRA, in either of the following ways:
| Type of Change | Description | Fees | Notification Number |
|---|---|---|---|
| Type 1 Change | Changes that only require amendments to the current notification. | No charge required | Notification number remains the same. |
| Type 2 Change | Changes that require a new notification. | Processing fee RM 50.00 | New notification number will be issued to the product. |
How to obtain a Certificate of Free Sale (CFS) in Malaysia?
The application for CFS must be through online submission by the CNH via Quest system and a fee of RM 50.00 is charged for each copy of the certificate.
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