A Cosmetic Notification Holder (CNH) in Malaysia is a locally incorporated company or a legal entity with a permanent address and registration with the Companies Commission of Malaysia (CCM). A CNH may or may not be the proprietor of cosmetic products. Still they are, responsible for notifying the National Pharmaceutical Regulatory Agency (NPRA) prior to the manufacturing, selling, supplying, importing, or possessing of any product. In this article, we shall explore the profound importance of a CNH in the Malaysian cosmetic market, taking a glance at their diverse responsibilities and key role in the submitting cosmetic notifications.
The Responsibilities of a CNH
- All transactions with the Malaysian Health Authority (HA), specifically the NPRA, must be carried out by persons appointed by the CNH.
- The CNH must ensure that the notified product complies with all the stipulated regulations and guidelines for cosmetic products.
- The CNH should maintain an up-to-date Product Information File (PIF) and be able to provide updated information and documentation on product quality, safety, and claimed benefits upon request.
- In the event of a product recall by the NPRA, the CNH must ensure that all the affected cosmetic products are removed from the market and that their sale and supply are completely discontinued. They also need to maintain proper distribution records for recall purposes.
- The CNH should submit any change(s) to the particulars of a notified product accordingly.
- The CNH must ensure that the manufacturer (and assembler, where applicable) of the cosmetic product is compliant with Cosmetic Good Manufacturing Practices (cGMP).
- In the incidence of serious adverse events, the CNH should report the event to the NPRA appropriately.
- The CNH should be able to provide truthful and complete particulars/details for product notification, along with all the relevant data and information.
- The CNH needs to verify that each consignment continues to meet all the legal requirements and, moreover, conforms to the standards and specifications declared for the product.
- When a product fails to conform to any of the standards or specifications, the CNH cannot rely on the acceptance of the product notification in any legal proceeding(s).
- The CNH must maintain updated correspondence details, such as the company’s name, address, contact person, telephone number, fax number, and email.
- The CNH should inform the NPRA of the cessation of their authorization in writing.
- The CNH should inform the NPRA of any decision to withdraw the notification of a product, along with the relevant reasons.
The Key Role of a CNH in the Submission of Cosmetic Notifications
All cosmetic notifications must be submitted online through the NPRA’s Quest3+ system on its official website. The CNH must complete the notification for each cosmetic product and any variant(s), if applicable, on the Quest3+ system, proceed with the payment to the NPRA, and once these steps are carried out, ensure the completion of the submission process.
Thus, it is essential to have a CNH in place when launching cosmetic products in the Malaysian market. To streamline your process and effectively address the challenges involved, consult an experienced service provider like Freyr and get Regulatory assistance!