Malaysia NPRA Cosmetic Notification: Requirements and Process

Malaysia’s National Pharmaceutical Regulatory Agency (NPRA) oversees the cosmetic notification process to ensure product safety and quality. This article breaks down the notification steps, regulatory documentation, and important compliance considerations for companies seeking to introduce cosmetic products into the Malaysian market.

Understanding ASEAN Cosmetic Regulations

The Association of Southeast Asian Nations (ASEAN) introduced the ASEAN Harmonised Cosmetic Regulatory Scheme (AHCRS) to unify safety and quality standards for cosmetics across its 11 member states, including Malaysia, Thailand, Vietnam, Myanmar, Cambodia, Laos, Singapore, Indonesia, the Philippines, Brunei, and Timor-Leste.

Since the implementation of the ASEAN Cosmetic Directive (ACD) in 2008, cosmetic products manufactured or sold in one ASEAN country can be marketed in other member states, provided they meet local notification requirements. However, separate notifications must still be completed for each country to comply with local laws.

Malaysia Regulatory Documents on Cosmetic Product Notification

Control of Drugs and Cosmetic Regulations 1984
Guidelines for Control of Cosmetic Products in Malaysia (2022)
NPRA Announcements on Ingredient Revisions:
- Circular No. 2/2023
- Circular No. 1/2023
Guidelines for Cosmetic Claims
Manual for QUEST3+ Online Submission for Cosmetic Notification

Competent Authority in Malaysia: NPRA

In Malaysia, cosmetic products are regulated by the Drug Control Authority (DCA) and National Pharmaceutical Regulatory Agency (NPRA).

DCA is the authority responsible for the regulation of cosmetics products in Malaysia. NPRA acts as a secretariat to the DCA which is in charge of the cosmetic notification process and the post-market surveillance.

What Does “Cosmetic Notification Holder” Mean in Malaysia?

The Cosmetic Notification Holder (CNH) refers to a company that is responsible for placing a cosmetic product on the market. The CNH is responsible for the notifications, who may or may not be the product owner.

The CNH must be a local company or legal entity, with a permanent address and registered with the Companies Commission of Malaysia (with the scope of business related to the health/cosmetic product as it appears in the `Memorandum and Article of Association’ of the company).

Steps to Notify Cosmetics in Malaysia

Businesses must follow a structured process to ensure compliance before marketing products in Malaysia.

Formula and Packaging Review: Ensure the product formula and packaging comply with NPRA guidelines.
Register for Quest Membership: Before the submission for notification, a CNH must first register for a Quest membership.
Online Submission: Submit the required documents via the NPRA online Quest system. The administration fee for notification is RM50.00 for each product.
Notification Approval: Once reviewed and approved by NPRA, a Notification Note can be generated from the Quest system, allowing the product to be marketed. The Notification Note shall be valid for 2 years.

Notification Completion Time: 3–4 weeks.

To know your ingredient regulatory status, try our COSMETIC INGREDIENT SEARCH TOOL for a comprehensive search.

Documents Required for Malaysia Cosmetic Notification

Product Details:
- Product name
- Product type
- Intended usage
- Product presentation
Manufacturer Information:
- Name and address of the manufacturer (if applicable)
CNH Information:
- Name, address, and valid contact details (phone number and email)
CNH Representative Information:
- Personal details of the individual representing the holder, including valid contact information
Importer Information:
- Name and address of the importer (if applicable)
Complete Product Ingredient List:
- Full ingredient list, and restricted ingredient content (if applicable)
Authorization Letter:
- Authorization documents from brand owner to CNH (if applicable)
Product Labeling:
- Labels must meet Malaysia’s regulatory standards.

Product Information File (PIF) Requirements in Malaysia

After completing the notification process, businesses must maintain a Product Information File (PIF) to ensure ongoing compliance during inspections.

The PIF shall be in Bahasa Malaysia or English. The PIF should include:

Qualitative and Quantitative Composition
Specifications for Ingredients and Finished Products
Production Methods: Documentation of processes complying with Good Manufacturing Practices (GMP).
Safety Evaluations: Safety data for the finished product and its ingredients, including their chemical structures and potential exposure risks.
Adverse Effects Data: Records of any known adverse effects of the cosmetic product on human health.
Efficacy Claims Support: Evidence supporting the product’s performance and efficacy claims.

How REACH24H Can Help with Malaysia Cosmetic Notification

At REACH24H, we offer tailored regulatory services to help businesses successfully navigate Malaysia’s cosmetic notification process. Stay compliant with Malaysia’s NPRA cosmetic regulations by partnering with experts who streamline the notification process. Reach out to us today to ensure a seamless entry into Malaysia’s cosmetics market.

Our expert support includes:

Ingredient Compliance Reviews: Checking for banned or restricted substances in your formula.
Labeling and Formula Review: Ensuring your product meets Malaysia’s packaging and formulation requirements.
Document Preparation: Assisting with the submission of all required notification documents.
PIF Compilation and Maintenance: Preparing and organizing a fully compliant Product Information File.
Regulatory Updates and Alerts: Keeping you informed of the latest changes in Malaysia’s cosmetic regulations.

Why Choose REACH24H for Your Cosmetic Compliance Needs

With professional experience and a proven track record of assisting more than 1,000 global cosmetic companies, REACH24H provides innovative regulatory solutions that ensure compliance. Our team ensures your products meet Malaysia’s standards and enter the market seamlessly.

For more information, contact us at customer@reach24h.com.