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How to Register a Health Supplement in Malaysia
Selling health supplements in Malaysia involves more than just labeling and distribution. All supplements—whether local or imported—must be registered with the National Pharmaceutical Regulatory Agency (NPRA) under the Ministry of Health (MOH) before they can be sold to consumers.
Here’s a simplified overview of the process:
- Skincare (moisturizers, creams, lotions)
- Haircare (shampoo, hair dye)
- Makeup (foundation, lipstick, mascara)
- Perfumes and deodorants
Steps to Register a Cosmetic Product
Step 1: Product Classification & Ingredient Review
Determine whether your product is classified as a health supplement, traditional medicine, or drug based on its function, claims, and ingredients. We will also review your formulation and label to ensure all components are allowed and within permitted limits under NPRA guidelines.
Step 2: Register Your Malaysian Company with MOH
To submit a product registration, your company must be registered locally in Malaysia and licensed as a Product Registration Holder (PRH). If you're a foreign brand, you will need a Malaysian agent to act as your PRH.
Step 3: Register the Manufacturer
The manufacturer—local or overseas—must hold valid GMP (Good Manufacturing Practice) certification. This information must be declared in your submission and approved by NPRA.
Step 4: Submit Product Dossier
A full dossier must be prepared and submitted through the Quest 3+ system, including:
Product formula
Label and packaging
Certificate of analysis
Manufacturing license and GMP certificate
Safety and efficacy data (if applicable)
The registration process may take up to 6 months depending on product complexity and NPRA response times.
Step 5: Post-Approval Compliance
Once approved, your product will receive a MAL number (e.g., MAL20123456NC), which must appear on the product label. Even after approval, NPRA may conduct post-market audits, so ongoing compliance is essential.
Common Issues That Delay Registration
- Using non-approved ingredients or dosage levels
- Incomplete documentation
- Foreign companies applying without a local PRH
Need Help With Supplement Registration?
Our experienced team of pharmacists and regulatory affairs experts can guide you from start to finish—from classification and documentation to NPRA submission and final approval.
Contact us for expert assistance in registering your supplement product in Malaysia.
