4.1 Post Market Surveillance Activities
4.2 Product Sampling Requirements
4.3 Product Complaint
4.4 Reporting Of Adverse Event
4.5 Notification of Product Quality Issue (PMAS)

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: Heavy Metal And Microbiological Test Limit For Cosmetic Product.

4.3 Product Complaint

The CNH shall investigate all complaints related to quality and safety problems pertaining to their notified cosmetics of which the CNH is aware and responsible to determine appropriate corrective and preventive action. Please also refer to Guidelines on Good Distribution Practice, which is available at NPRA’s website.

4.4 Reporting Of Adverse Event

CNH shall report any serious adverse events or high incidences of adverse events occurred, regardless of the source of the report (e.g. consumer and healthcare professional). Please refer to Annex I, part 15: Guide Manual for Adverse Event Reporting for more information.

4.5 Notification of Product Quality Issue (PMAS)

NPRA may notify other regulatory authorities or stakeholders regarding the recall and/or other regulatory action of a defective cosmetic product in order to protect public health.