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Malaysia: Revises Guidelines for Control of Cosmetics Products

  •   9 Mar 2017
  •    Jo Zhou
  •  4270
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    Takehome:

    Malaysia revised its "Guidelines for Control of Cosmetics Products" (replacing the 2008 edition), which serves as the standard for the cosmetic notification process including quality control, inspection and post-market surveillance. This guideline became effective on 1st Feb. 2017.

    Compared to the previous 2008 guidelines, the new version introduces the concept of Cosmetic Notification Holder (hereinafter referred to as 'CNH'), to fulfill notification application responsibilities. The guidelines also outline an overall policy strengthening the post-market surveillance. Two more important issues have been revised including: 1) the certificate of free sale and 2) HALAL logo requirements.

    New Concept of CNH:

    The 2008 guidelines stipulated "the company or person responsible for placing cosmetic products in the market" should shoulder the duty of applying for notification. The new guidelines stipulate that "the CNH" is the individual which notifies the Director of Pharmaceutical Services (known as DPS) prior to manufacture, sell, supply, import or possession of any cosmetic product. To be more specific, the CNH is required to comply with all requirements stated in this guideline and to make a declaration upon notification to the Director of Pharmaceutical Services (known as DPS) through the National Pharmaceutical Regulatory Agency (NPRA).

    The CNH also has the following responsibilities and should ensure the following:

    a) All transactions with NPRA shall be carried out by CNH's appointed person(s).

    b) Notified product meets all stipulated regulations and guidelines for cosmetic product.

    c) Product Information File (PIF), including updated information/document on product quality, safety and claimed benefit is available and accessible upon request.

    d) If and when directed by NPRA for product recall, CNH must ensure all affected cosmetic products are recalled from the market and all sale and supply discontinued. A product distribution record must be properly kept for recall purposes.

    e) Change(s) to notified product particulars is submitted accordingly.

    f) Manufacturer (and assembler, where applicable) of the cosmetic product is compliant with Cosmetic Good Manufacturing Practice (CGMP).

    g) In the incidence of serious adverse event, CNH shall report to NPRA appropriately.

    h) Particulars given for product notification are truthful where all data and information of relevance to the notification has been provided.

    i) Each consignment continues to meet all legal requirements and conforms to standards and specifications declared for the product.

    j) When a product failed to conform to any of the standards or specifications declared for the product, CNH cannot place reliance on the acceptance of the product notification in any legal proceedings.

    k) Correspondence details such as company's name, address, contact person, telephone number, fax number and email shall be kept updated.

    l) Cessation of the authorization of the CNH shall be informed to the NPRA in writing.

    m) Any decision to withdraw the notification of a product shall be informed to the NPRA, with reasons.

    In summary the CNH have the most responsibility to guarantee cosmetics safety and quality and to ensure full compliance with regulatory and administrative standards.

    Activities for Post-market Surveillance

    The NPRA shall monitor compliance of cosmetic products through Post Market Surveillance (PMS) program. In the new guidelines, more activities are added to PMS program.

    Comparison of activities in PMS Program

    2008 Edition

    2017 Edition

    Screening of product formulation and information

    Screening of product formulation and information to ensure that cosmetics do not contain any prohibited or harmful substances and all restricted ingredients are used within the allowable limits and conditions of use

     

    Screening criteria also includes product name and its claimed benefits

    Audit on the Product Information File (PIF) for compliance with the regulations

     

    Sample collection, testing and monitoring of label compliance

    Sample collection and testing

     

    Monitoring of label compliance

    Audit of premises to ensure compliance with ASEAN Guidelines for Cosmetic Good Manufacturing Practice

    Audit of premises for compliance to the Cosmetic GMP

    Investigation of complaints

    Handling of product complaints

    Monitoring of cosmetic advertisement

    Monitoring of advertisements

    Monitoring of adverse reactions from cosmetic products

    Monitoring of adverse reactions

     

    Audit on the PIF Risk communication

    Initiation of warning and information sharing system between ASEAN countries

    Information sharing through ASEAN

    Post Marketing Alert System (PMAS)

    Note: Product Information File (PIF), which would be inspected by post-market surveillance, is now the responsibility of CNH.

    Two Newly Raised Issues

    1. Certificate of Free Sale

    A certificate of free sale (CFS) serves as a document which states that the product can be freely sold in Malaysia. The certificate is not a mandatory requirement. As such, it will only be issued by the NPRA upon request by the CNH who wish to export their notified cosmetic product to another country that requires the certificate.

    The application for CFS can only be made online by the CNH via the Quest system and a fee of RM50.00 will be charged for each copy of the certificate. The product and variant can be combined into one certificate provided that the latter is notified as a variant of the main product.

    1. HALAL

    Halal logo may be used voluntarily on a notified cosmetic product, for both the local and export market, provided the product has been certified and approved as Halal by the Malaysia Department of Islamic Development (Jabatan Kemajuan Islam Malaysia, JAKIM) or any Islamic Body recognized by JAKIM.

    Specific information you may see: whole guidelines from CL.

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