5. Regulatory Action

Kadar pengguna: 3 / 5

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5.1 Rejection of Notification Submission
5.2 Cancellation of Notification Note
5.3 Product Recall
5.4 Punitive Action/Penalty


5.1 Rejection of Notification Submission

All cosmetic notification submission shall be subjected to screening by NPRA. Cosmetic product found to contain substances that are prohibited or used beyond the limit and conditions allowed as well as product claimed or purported to be used beyond the cosmetic scope will be denied for notification.



5.2 Cancellation of Notification Note

The DPS may, at any time cancel the notification note of any cosmetic product if he has the reason to believe that the product failed to comply with the stipulated regulations and guidelines. The DPS may also amend any conditions to which the notification note is subject.

The cancellation takes effect when the DPS gives a written notice (known as directive) of cancellation. The CNH must follow all instructions given in the directive issued by the DPS including but not limited to recall and disposal of the affected product. A formatted report must be prepared and submitted within the specified time as mentioned in the directive.




5.3 Product Recall

The decision for recall of a product shall be made when there is potential risk to the user of the products. Recalls may be done voluntarily by the CNH or as directed by the DPS. The CNH is responsible for conducting recalls of defective or unsafe products. No recall should take place without first consulting/informing the NPRA. Please refer to Guidelines on Good Distribution Practice at NPRA’s website and Annex I, Part 16: Guideline For Industry - Reporting and Recall of Cosmetic Product – Reporting and Recall of Cosmetic Product for more information.




5.4 Punitive Action/Penalty

Any person who contravenes any of the provisions of the guidelines and regulations commits an offence and shall be liable on conviction as stipulated under Section 30 (1) of the CDCR 1984.


National Pharmaceutical Regulatory Agency (NPRA)

Lot 36, Jalan Universiti (Jalan Prof Diraja Ungku Aziz), 46200 Petaling Jaya, Selangor, Malaysia.

  • Phone: +603-7883 5400




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