What is Defined as a Cosmetic Product?
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”.
What is Cosmetic Product Notification?
Under the Control of Drugs and Cosmetics (amendment) Regulations 2007, the company or person responsible for placing a cosmetic product in the local market must notify the National Pharmaceutical Regulatory Agency (NPRA) prior to product manufacture or importation.
Cosmetic notification process will allow the NPRA to gather adequate information on the cosmetic products that are placed in the local market. It is an offence for anyone to manufacture or import a cosmetic product without prior notification to the NPRA.
Step-by-Step Guide: How to Notify a Cosmetic Product with NPRA in Malaysia
Step 1: The company must first register as a Cosmetic Notification Holder (CNH) via NPRA’s Quest 3+ system.
Homepage of NPRA Quest 3+ Sytem
Step 2: CNH to fill up relevant information and provide the relevant documents in the Quest system such as certificate of incorporation.
Step 3: Payment for membership application: The charges for Quest membership would range between RM 260 and RM 290 depending on the validity period of the membership.
Source: NPRA Guidelines on Cosmetics – Annex 1. Part 3 Charges for Quest Membership
Step 4: Upon successful registration for CNH, notifications of the cosmetic products shall be done online through Quest 3+ system
Step 5: Payment of RM 50 for notification of each cosmetic product.
Step 6: The cosmetic products will undergo a compliance screening to determine whether it complies with the regulatory requirements.
Step 7: If it complies, the notification note will be generated, and the cosmetic products can be registered and enter the market.
Step 8: The notification of cosmetic products shall be valid for two (2) years and the renewal of the same should be done no later than one (1) month prior to notification expiry
Cosmetic Notification as a Manufacturer
Manufacturers of cosmetics in Malaysia must also comply with Good Manufacturing Practice (GMP) requirements prior to product notification. The GMP standards ensure that cosmetic products are produced consistently and in a controlled manner, adhering to quality standards that minimize the risks associated with the product’s use. Manufacturers must demonstrate that their products comply with GMP guidelines by providing the necessary documentation during the notification process through the NPRA Quest system.
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