|Guidelines for Control of Cosmetic Products in Malaysia(2017)|
|National Pharmaceutical Regulatory Agency (NPRA)|
|Main Supporting Rules|
|June 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 by the National Pharmaceutical Control Bureau (NPRA 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 NPRA. Post Market Surveillance will be actively conducted by the NPRA to ensure compliance. Action will be taken against any product that is not compliant with the 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|
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 Control Bureau (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 placedin 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.
A company who wants to place cosmetic products in the market must notify the DPS through NPRA prior to manufacture, import, supply or sale of products. The company is the one who is responsible for ensuring safety, quality, performance or efficacy of the cosmetic product placed in Malay market and to ensure that the product complies with the regulations.
Applicants who must be a company in Malaysia are required to make the notification through NPRA’s Quest 2 system. The notification is not complicated at all but only need to fill in the Product Notification Form with some basic information relating to their products such as product name, intended use, name and addresses of manufacturer and ingredient list (click here to see the notification template).
However, for skin whitening products, there is an additional requirement, that is, applicants shall submit an original certificate of analysis for finished products within 1 month after product has been notified to NPRA.
If the applicant is not the product owner, a written authorization requires submission. The information related to the owner is also needed to be provided in the Quest 2 system.
All documents submitted must be in English or Bahasa Malaysia.