National Pharmaceutical Regulatory Agency (NPRA) Malaysia
Link for RA:
Control of Drugs and Cosmetic Regulations (CDCR) 1984
Who can register :
Cosmetic Notification Holder (CNH): Cosmetics-related locally incorporated company or legal entity with a permanent address and registration with the Malaysian Companies Commission. The CNH may or may not be the proprietor of the product.
Data to be communicated :
- Specifications of the products, such as the name, type, intended application, and presentation
- Name, address, and legitimate contact number (and e-mail address) of the manufacturer(s) and assembler(s), if applicable.
- Details of the person representing CNH, including a working phone number
- Complete product ingredient list (the content, i.e. proportion (percent) of the restricted components must be mentioned)
- Name and address of the importer(s), if any
- A letter of authorization, a declaration, or a letter of contract manufacturing is required.
- The product’s label(s)
Product Information Requirements:
- The product’s qualitative and quantitative composition, and in the case of perfume compositions, the composition’s name and code number, as well as the identity of the supplier
- Raw material and final product specifications
- The production technique is per the Guideline for Cosmetic Good Manufacturing Practices.
- Evaluation of the finished product, its ingredients, their chemical structure, and the degree of exposure for human health.
- Existing evidence of harmful effects on human health as a result of using the cosmetic product
- Prior to manufacturing, selling, supplying, importing, or possessing any cosmetic product, the Cosmetic Notification Holder (CNH) must notify the DPS.
- All notice submissions must be made online through the NPRA Quest system on the NPRA website at http://npra.moh.gov.my.
- A CNH must first register for a Quest membership before submitting a notification request. On the NPRA website, there is a step-by-step tutorial on registering for Quest membership.
Timeframe and fees:
The notification of a cosmetic product shall be valid for two years.
The processing fee for notification of a cosmetic product is RM 50.00 for each product.