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The Cosmetic Product Notification(CPN)to National Pharmaceutical Regulatory Agency (NPRA), Malaysia

In the vibrant world of cosmetics, Malaysia is a key player with a diverse and thriving beauty industry. As consumers continue to seek quality and safety in beauty products, understanding the regulatory framework governing cosmetics in Malaysia becomes crucial for manufacturers, distributors, and consumers alike. 


The Cosmetic Product Notification(CPN)to National Pharmaceutical Regulatory Agency (NPRA), Malaysia

The cosmetics regulation in Malaysia falls under the purview of the National Pharmaceutical Regulatory Agency (NPRA), a division of the Ministry of Health (MOH). The NPRA oversees the implementation of the Control of Drugs and Cosmetics Regulations 1984, ensuring the safety, quality, and efficacy of cosmetic products in the Malaysian market.


Though the cosmetic registration in Malaysia is not required, manufacturers and importers must notify the NPRA before placing a product in the market. The Cosmetic Notification Malaysia Portal allows businesses to submit information about their cosmetic products, ensuring the authorities can trace and monitor products for safety and compliance. 


Cosmetic Notification Holder (CNH)


The Cosmetic Notification Holder (CNH) is the locally incorporated company or legal entity responsible for registering cosmetic products in Malaysia. The CNH, which may or may not be the product proprietor, must have a permanent address and be registered with the Malaysian Companies Commission. The entity responsible for placing cosmetic products in the market, whether the product owner or not, is obliged to notify the National Pharmaceutical Regulatory Agency (NPRA) before manufacturing, importing, supplying by wholesale, or selling the products. If the notifying entity is not the product owner, written authorization from the owner is required. Responsibilities of the Cosmetic Notification Holder Malaysia (CNH) include ensuring:


  • All transactions with NPRA are conducted by CNH’s appointed person(s). 

  • The notified cosmetic product complies with Cosmetic regulations Malaysia and guidelines. 

  • The Product Information File (PIF) is available and accessible, containing updated information on product quality, safety, and claimed benefits. 

  • Product recall is conducted if directed by NPRA, with proper records kept for recall purposes. 

  • Changes to notified product particulars are submitted accordingly. 

  • The manufacturer complies with Good Manufacturing Practice (cGMP). 

  • Reporting to NPRA in the case of a serious adverse event. 

  • Truthfulness of particulars given for product notification. 

  • Each consignment continues to meet legal requirements and conforms to declared standards. 

  • In the case of non-conformity, CNH cannot rely on product notification acceptance in legal proceedings. 

  • Keeping correspondence details updated. 

  • Informing NPRA in writing about the cessation of CNH authorization. 

  • Informing NPRA of any decision to withdraw the notification of a product, along with reasons.


Cosmetic Product Notification (CPN) Malaysia:


The Cosmetic Product Notification is mandatory for all cosmetic products before manufacture, sale, supply by wholesale, and import. The company or person carrying out Cosmetic Product Notification must be registered.


  • Authorization Requirements: Manufacture, importation, and wholesale activities must be authorized. Post-market surveillance is conducted to ensure ongoing compliance.

  • Notification Procedure: Notification is done online through the NPCB website (www.bpfk.gov.my/Quest2). Applicants must register for a digital certificate for access to the Quest2 online system.

  • Document Requirements: A Letter of Authorization from the product owner, including the product list, is required if the notifier is not the product owner. For skin whitening products, an original Certificate of Analysis for the finished product must be submitted within one month after Cosmetic Product Notification.

  • Language and Privacy: All documents submitted to NPCB must be in English or Bahasa Malaysia. Information is treated as 'commercial-in-confidence,' irrespective of markings.

  • Product Variant and Manufacturer: Variants may be submitted in one application, with additional variants added with the appropriate fee. Multiple manufacturers may be submitted in one Cosmetic Product Notification application if the product name and formulation are identical.

  • Fees and Validity: A processing fee of RM50.00 is required for Cosmetic Product Notification of each product and variant. An annual fee of RM500.00 is applicable for wholesale authorization. Notification is valid for two years, with renewal required one month before expiry.

  • Authorization and Changes: Authorization for manufacturing or importing is granted upon receipt of the Cosmetic Product Notification Note. The notification number is generated 1-3 days after payment for self-printing of the Notification Note. Any subsequent changes in notified product particulars must be communicated to the authority.


These procedures ensure that cosmetic products meet regulatory standards, and the notification system is designed to facilitate compliance and ongoing monitoring.


Product Information File (PIF) - 


The Product Information File (PIF) for cosmetic products in Malaysia is the responsibility of the Cosmetic Notification Holder (CNH), who must provide all requested information, certificates, documents, and data to the National Pharmaceutical Regulatory Agency (NPRA). The PIF can be in the form of a dossier or electronic format, readily available and accessible in Bahasa Malaysia or English. Key points regarding the PIF include:


  • Responsibility of CNH: CNH is responsible for providing all requested information to the NPRA. The PIF must be available in either paper or electronic form and accessible upon NPRA's request. It should be kept updated for any changes to the notified product.

  • Recommended Organization of PIF: It is recommended to organize the PIF into four parts: Administrative Documents and Product Summary, Quality Data of Raw Material, Quality Data of Finished Product, and Safety and Efficacy Data. A Table of Contents should be provided for each of the four parts.

  • PIF Audits: The NPRA conducts audits of the PIF at the address specified on the label. There are two types of audits: Routine audits, which are announced in advance, and Ad-hoc audits, triggered by market sample results or consumer complaints. For routine audits, it is recommended to announce them sufficiently in advance (at least 1 month). Ad-hoc audits may be announced at least 48 hours in advance or, in extreme urgency, may take place without announcement.


Post-Market Surveillance:


Post-Market Surveillance for cosmetic products in Malaysia, conducted by the National Pharmaceutical Control Bureau (NPCB), involves monitoring compliance in the marketplace and at the premises of the company responsible for placing the product in the market. Key points include:


  • Product Information File (PIF): The company placing the product is responsible for providing all information, certificates, and data requested by the NPCB for the PIF. Regular updates are required for any modifications, such as new ingredients, manufacturers, raw material suppliers, production processes, or other relevant information.

  • Safety Assessment: A cosmetic product must not cause harm to human health under normal or reasonably foreseeable conditions of use. The company or person placing the product in the market is responsible for ensuring a safety assessment has been conducted.


Compliance with these regulations ensures ongoing safety and quality assurance of cosmetic products in the Malaysian market.


Labeling requirements - 


The company or person responsible for placing the cosmetic product in the market must ensure compliance with labeling requirements. Labeling encompasses information in written, printed, or graphic form on immediate or outer packaging and any leaflets. Labeling must include the name of the Cosmetic Product, which refers to the name given to a cosmetic product, which may include an invented name, trademark, or the manufacturer's name. Labels must be clear, accurate, and provide essential information such as the product name, ingredient list, manufacturer's details, batch number, and expiration date. The information on the label must be in English and/or Bahasa Malaysia. 

The Halal logo may be used voluntarily on a notified cosmetic product for both local and export markets. The product must be certified and approved as Halal by the Malaysia Department of Islamic Development (JAKIM) or any Islamic Body recognized by JAKIM.


Recent Regulatory changes by NPRA – 


The NPRA provides a list of prohibited and restricted substances in cosmetics to safeguard consumers. Cosmetic products must not contain ingredients that are harmful, prohibited, or exceed permissible limits. 


Malaysia has updated its cosmetic substances list to align with the ASEAN Cosmetics Directive (ACD), incorporating changes based on the requirements of the directive. Nineteen prohibited substances, including 2-Chloroacetamide, Acetaldehyde, Quinoline, Styrene, and Vinyl acetate, have been added, with a focus on substances classified as CMR (Carcinogenic, Mutagenic, or Toxic to Reproduction). The transitional period for existing products affected by these changes extends until May 8, 2025.

Additionally, three substances, namely Benzoic acid, 2-hydroxy-; Methyl N-methyl anthranilate; and Ammonium Silver Zinc Aluminium Silicate, have been added to the restricted substances list. Cosmetics containing these restricted substances will be prohibited from sale without approval after the Regulations come into effect.

Two substances, Sodium hydroxymethylamino acetate and 2-cyano-3, 3-diphenylacrylic acid, 2-ethylhexyl ester, are permitted for use. The ACD serves as a regional framework among ASEAN member countries, aiming to harmonize cosmetic regulations and reduce technical barriers to trade in the region. All ASEAN member countries, including Malaysia, must incorporate the revised content of the ACD into their national legislation. 


As the beauty industry evolves, challenges such as the rise of counterfeit products and the need for harmonization with international standards are becoming more apparent. The NPRA continues to work towards enhancing regulatory frameworks and aligning them with global best practices.


Navigating the regulatory landscape for cosmetics in Malaysia is crucial for a successful and compliant presence in the market. At Artixio, we specialize in providing comprehensive Cosmetic Notification Services to streamline the process for your cosmetic products. Our expert team ensures that your products meet all necessary regulations, allowing you to focus on what you do best – creating innovative and beautiful cosmetics.


Ready to ensure your cosmetic products comply with Malaysian regulations? Contact Artixio today for personalized Cosmetic Notification Services that align with the requirements set by the National Pharmaceutical Regulatory Agency (NPRA). Let us be your partner in achieving regulatory success in the dynamic world of cosmetics.


Contact Artixio for Your Cosmetic Notification Services Today!

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