4. Post Market Surveillance Programme

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4.1 Post Market Surveillance Activities
4.2 Product Sampling Requirements

 

4.1 Post Market Surveillance Activities

The NPRA shall monitor compliance of cosmetic products through Post Market Surveillance (PMS) programme. The PMS activities for cosmetics consist of:

  • 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
  • Sample collection and testing
  • Monitoring of label compliance
  • Audit of premises for compliance to the Cosmetic GMP
  • Handling of product complaints
  • Monitoring of advertisements
  • Monitoring of adverse reactions
  • Audit on the PIF
  • Risk communication
  • Information sharing through ASEAN Post Marketing Alert System (PMAS)

 

 

4.2 Product Sampling Requirements

For the purpose of checking the quality and/or label compliance, the NPRA may obtain a cosmetic sample from the market or request the sample from the CNH. The CNH shall ensure that the requested sample for laboratory testing fulfil the following criteria:

  • All samples must be from the same production batch
  • The sample should be presented in its originally marketed container/packaging and unopened
  • The sample label and package insert (if any) must not be taken out from the container/packaging
  • The expiry date should not be less than one year, calculated from the sample delivery date to the NPRA
  • Sample of a cosmetic product should at least consist of 4 units/containers, with a minimum total content of 40g/40ml (weight/volume of the product content without the container/packaging material)

Information on the limit used for heavy metal and microbial limit test are described in Annex I, part 14.

 

National Pharmaceutical Regulatory Agency (NPRA)
Lot 36, Jalan Universiti, 46200 Petaling Jaya, Selangor, Malaysia.
  • Email: npra@npra.gov.my
  • Phone: +603-7883 5400
  • Fax: +603-7956 2924, +603-7956 7075

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