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Entering the Malaysian Cosmetic Market
Cosmetic products intended for manufacture, import, or sale in Malaysia must be notified to the National Pharmaceutical Regulatory Agency (NPRA) before entering the market. This ensures compliance with Malaysian safety, quality, and labeling requirements aligned with the ASEAN Cosmetic Directive.Companies are responsible for maintaining proper documentation to support product safety and compliance.
TECOLAB is here to support you at every step of your cosmetic product compliance journey in Malaysia
Cosmetic Product Notification : Key Steps
The cosmetic product notification process in Malaysia involves several key steps to ensure compliance with regulatory requirements prior to market entry
Step 1 : CNH Appointment & QUEST Registration
A Cosmetic Notification Holder (CNH) is a locally registered entity responsible for ensuring that cosmetic products comply with all regulatory requirements set by the NPRA.
The CNH must register for membership in NPRA’s QUEST 3+ online system and obtain the required digital access token in accordance with NPRA requirements.
TECOLAB is here to support you throughout this process—assisting with your QUEST membership application or acting as your appointed CNH.
Step 2 : Manufacturer & Importer/Distributor Registration
The manufacturer and importer/distributor details must be registered in the NPRA’s QUEST 3+ online system , supported by the required documentation.
TECOLAB facilitates the submission of these details through the NPRA system, ensuring a smooth and efficient registration process.
Step 3 : Product Documentation Preparation & Review
All required documentation must be prepared in accordance with applicable regulatory requirements prior to submission. This includes ingredient information, labeling artwork, and the Certificate of Analysis (COA).
TECOLAB will review the documents to ensure compliance with applicable regulatory requirements before proceeding with the notification process.
Step 4 : Submission of Cosmetic Notification
The cosmetic product notification is submitted through the NPRA QUEST 3+ online system, together with the required product information and supporting documentation, followed by payment of the applicable processing fee.
TECOLAB facilitates the submission via the NPRA QUEST system, ensuring all required information is accurately captured and submitted in full compliance with regulatory requirements.
Step 5 : Compliance Screening & Notification Note
Following submission, the product undergoes a compliance screening by the NPRA to verify that all submitted information meets Malaysian cosmetic regulatory requirements.
Upon successful screening and payment, the CNH may generate the Notification Note through the system. This confirms that the product has been successfully notified and is permitted to be marketed in Malaysia, subject to ongoing compliance
TECOLAB supports this process by coordinating the submission and ensuring a smooth progression through the notification system.
Ongoing Compliance & PIF Preparation
Following successful notification, companies are required to ensure ongoing compliance with regulatory requirements and maintain the Product Information File (PIF) for inspection purposes. TECOLAB supports these requirements through the following services.
Post Market Compliance
After successful notification, products must continue to comply with regulatory requirements set by the NPRA. TECOLAB supports ongoing compliance by providing regulatory guidance, assisting during inspections, and offering continuous compliance advisory.
Product Information File (PIF) Preparation
Support in preparing and maintaining the Product Information File (PIF), ensuring that all technical and safety information is properly documented.