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Overview:

Cosmetic products in Malaysia are regulated under the Control of Drugs and Cosmetic Regulations 1984. From year 2002 to the end of year 2007, the control of cosmetic products was 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 (NPCB) before the product can be manufactured, imported or sold in the country.

In conformance with the harmonization of cosmetic regulations in the ASEAN region, this system has been replaced by a notification procedure starting 1 January 2008. Instead of registration, companies are now required to only notify / declare their compliance to the ASEAN Cosmetic Directive to the NPCB. Post Market Surveillance will be actively conducted by the NPCB to ensure compliance. Action will be taken against any product that is not compliant with the Directive.

The requirements of the ASEAN Cosmetic Directive have been adapted into the Guidelines for Control of Cosmetic Products in Malaysia.

Notification Procedure

The company responsible for placing a cosmetic product in the local market must submit a notification to the Director of Pharmaceutical Services (DPS) through the National Pharmaceutical Control Bureau (NPCB) prior to any marketing, manufacturing, importing or wholesaling of the product. A Notification Note should be printed out for every product and variant (if any) and will act as authorization to carry out the above-mentioned activities.

Notification must be carried out online via the Quest3 system available on the NPCB official website, www.bpfk.gov.my

Responsibility of the Company Placing the Product in the Market

A company that brings a particular product into the market is fully responsible for the safety, quality and efficacy of the product. Cosmetic products must not contain any substance that may cause harm to the consumer when applied under normal or reasonably foreseeable conditions of use.
Please refer to the Guidelines for Control of Cosmetic Products in Malaysia for details of the compliance requirements.

Post Market Surveillance

Active product monitoring via the Post Market Surveillance (PMS) program will be conducted by the authority to ensure that only safe products are being marketed. The activities will consist the following:

  1. Screening of product formulation and information
  2. Audit on the Product Information File (PIF) for compliance with the regulations
  3. Sample collection, testing and monitoring of label compliance
  4. Audit of premises to ensure compliance with ASEAN Guidelines for Cosmetic Good Manufacturing Practice
  5. Investigation of complaints
  6. Initiation of warning and information sharing system between ASEAN countries
  7. Monitoring of adverse reactions from cosmetic products
  8. Monitoring of cosmetic advertisement



 
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