Malaysia Cosmetics Legislation

  •   21 Sep 2016
  •    Angelita Hu

     Malaysia Cosmetics Legislation

    Overarching Regulation
    Guidelines for Control of Cosmetic Products in Malaysia(2017)
    Competent Authority
    National Pharmaceutical Regulatory Agency (NPRA)
    Main Supporting Rules 
    Jun 13 2007Asean Guidelines for Product Information File (PIF)
    May 8 2007Asean 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.

    Contents

    Part 1 Regulatory Framework and Competent Authority

    1 Existing Main Cosmetic Regulations in Malaysia

    Regulations

    Remark

    ASEAN Cosmetic Directive

    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

    Template for Notification of Cosmetic Product

    Lists all the information needed for notification

    Asean Guidelines for Product Information File (PIF)

     

    Guidelines for Safety Assessment of Cosmetic Product

    Formulated especially for cosmetic safety assessment requested in the PIF

    ASEAN Guidelines for Cosmetic Good Manufacturing Practice

     

    ASEAN Cosmetic Labeling Requirements

     

    ASEAN Cosmetic Claims Guidelines

     

    Cosmetic Advertising Code

     

    2 Competent Authority

    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.

    Part 2 Cosmetic Products

    1 Definition

    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).

    2 Manufacturing Requirements

    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.

    3 Notification

    malaysia cosmetic regulationsThe 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

    Any question?

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