简介
- The cosmetic notification process with the National Pharmaceutical Regulatory Agency (NPRA) is a mandatory requirement in Malaysia for all cosmetic and personal care products intended for distribution, sale, or importation. This process ensures that products meet strict standards of safety, ingredient compliance, and quality, as regulated by the Ministry of Health Malaysia. Notified products are granted an official Notification Note (NOT Number), enabling them to be marketed legally in compliance with Malaysian laws and regulations. This process protects public health by ensuring that only safe and high-quality products are available in the market while also fostering trust between consumers and product brands.
负责部门
- 国家药品监管机构 (NPRA) 隶属马来西亚卫生部 (Kementerian Kesihatan Malaysia, KKM)
执照名称（马来文）
- Notifikasi Produk Kosmetik (melalui sistem QUEST3+)
详情
- 范围：
- Cosmetic and personal care products for external use (including skincare, makeup, hair care, body care, and oral hygiene).
- 要求：
- Submission must be made exclusively through the NPRA's QUEST3+ online system.
- The applicant must be a locally incorporated company in Malaysia acting as the Product Notification Holder (CNH).
- Full submission of the product formulation and 100% ingredient percentage breakdown.
- Strict safety and ingredient compliance verification against the ASEAN Cosmetic Directive (ACD) Annexes.
- 申请流程：
- The applicant registers and activates a corporate user account within the NPRA QUEST3+ digital portal.
- Preparation and upload of required digital assets, including full ingredient details, manufacturer company data, and final packaging/labeling artwork layouts.
- Digital submission of the cosmetic notification form via the QUEST3+ platform.
- Online settlement of the mandatory statutory processing fee to the government.
- Instant system validation and generation of the unique NOT tracking number.
- 所需文件：
- Detailed product formulation and ingredient percentage listing.
- Clear digital layouts of the product labeling, outer packaging text, and artwork.
- Valid proof of manufacturer status (such as a Good Manufacturing Practice (GMP) certificate or a Manufacturer's License).
- Letter of Authorization (LoA) if an appointed agent or consultant is submitting the application on behalf of the brand owner.
- 制造商认证文件。
- Processing and approval time takes 1 to 3 working days upon successful online payment confirmation.
- 注册有效期：
- The cosmetic notification (NOT) is valid for 2 years, subject to renewal before the expiry date.
重要规定
- Products must not contain any prohibited substances (e.g., mercury, hydroquinone, tretinoin) or restricted ingredients exceeding the legal thresholds set by the ASEAN Cosmetic Directive.
- Misleading, exaggerated, or unsubstantiated therapeutic claims on product labels or packaging are strictly prohibited (cosmetics cannot claim to "cure" or "treat" medical illnesses).
- Notified products must clearly display their valid NOT number, country of origin, batch number, manufacturer/importer details, and a full ingredient list on their physical packaging.
- Unauthorized changes to the chemical formulation or product name after the notification note is issued are not allowed; any major variation requires a brand-new notification submission.
违规罚款与处罚
- Unnotified Products:
- (Individuals): Fine up to RM25,000, imprisonment up to 3 years, or both for a first offense under the Control of Drugs and Cosmetics Regulations 1984.
- (Company): Fine up to RM50,000 for a first offense.
- Repeat Offenses:
- (Individuals): Fine up to RM50,000, imprisonment up to 5 years, or both.
- (Company): Fine up to RM100,000.
- 不符合标签规则：
- Fine up to RM25,000, imprisonment up to 3 years, or both.
- 虚假或误导信息：
- Fine up to RM50,000, imprisonment up to 5 years, or both.
顾问
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Commonly Asked Questions
It is a mandatory safety clearing process managed by the Ministry of Health Malaysia (KKM) that grants your cosmetic and personal care products a unique NOT number so they can be legally imported, distributed, and sold in the market.
Any locally incorporated Malaysian company (SSM holder) acting as the brand owner, authorized importer, or contract manufacturer must register as the Product Notification Holder to take legal accountability for the cosmetic items.
Applications are done through the official QUEST3+ online system.
The NOT number is issued for cosmetic products registered with NPRA, confirming they are approved for sale in Malaysia.
- DCA number: For pharmaceutical products
- NOT number: For cosmetic products
The processing time ranges between 6 to 12 months, depending on the product type and completeness of documentation.
Selling or distributing unregistered products is illegal and can result in fines or imprisonment.
Yes. Registrations are valid for five years and must be renewed before expiry.
Yes, but only with prior approval from the Medicine Advertisements Board (MAB).
We manage end-to-end NPRA registration, including dossier preparation, submission, and compliance consultation — ensuring faster approval and full legal compliance.