|Guidelines for Control of Cosmetic Products in Malaysia(2017)|
|National Pharmaceutical Regulatory Agency (NPRA)|
|Main Supporting Rules|
|Jun 13 2007||Asean Guidelines for Product Information File (PIF)|
|May 8 2007||Asean Guidelines for Cosmetic Good Manufacturing Practice|
From year 2002 to the end of year 2007, the control of cosmetic products was conducted through pre-market registration; where the company which is responsible for placing the product in the local market submit product details and relevant certificates for review and registration before the product can be manufactured, imported or sold in the country.
As a member state of ASEAN Malaysia agreed to replace the system with a notification procedure starting from 1 January 2008 in conformance with the harmonization of cosmetic regulations in the ASEAN region. Instead of registration, companies are now required to only notify/declare their compliance status 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 declaration and/or product found to be non- compliant to the stipulated regulations and guidelines.
Malaysia cosmetic regulations are completely in conformance with the harmonization of cosmetic regulations in the ASEAN region
|Guidelines for Control of Cosmetic Products in Malaysia(2017)||Reference for notification process including quality control, inspection and post-market surveillance activities of cosmetics|
Lists all the information needed for notification
Formulated especially for cosmetic safety assessment requested in the PIF
Director of Pharmaceutical Services (DPS) is the authority responsible for the regulation of cosmetics products.
National Pharmaceutical Regulatory Agency (NPRA) acts as a secretariat to the DPS which is in charge of the cosmetic notification process and the post-market surveillance.
The definition of cosmetics is based on the ACD. Cosmetics refer to 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 (click here to see the illustrative list of cosmetic product by categories).
The ASEAN guidelines on Good Manufacturing Practice (GMP) stipulates the requirements for manufacturing cosmetics in the respects of personnel, Premises, equipment, Sanitation and hygiene, etc.. Cosmetic manufacturers must ensure that their manufacturing conditions comply with the GMP. Local manufacturer is subjected to periodical inspection by GMP auditors from the NPRA to ensure continuous compliance. For foreign manufacturer, documentation to prove GMP compliance is to be made available upon request by the NPRA.
The Cosmetic Notification Holder (CNH) is responsible to notify the DPS prior to manufacture, sell, supply, import or possess any cosmetic product. The CNH refers to a company who is responsible for placing the cosmetic product in the market. The CNH must be a locally incorporated company or legal entity in the field of cosmetics, with permanent address and registered with Companies Commission of Malaysia (with the scope of business related to the health/cosmetic product as it appears in the `Memorandum and Article of Association’ of the company). The CNH may or may not be the product owner.
All submission for notification shall be done online through NPRA Quest system via NPRA’s website