National Pharmaceutical Regulatory Agency (NPRA) Cosmetic Notification (NOT)

License / Permit / Service Description

• Professional NPRA cosmetic notification support for businesses intending to manufacture, import, distribute or sell cosmetic products in Malaysia. We assist with the review of applicant and product information, coordination of supporting documents, preparation of notification details, assistance with submission through the relevant NPRA system and follow-up on notification status.Our service is suitable for cosmetic brand owners, local manufacturers, importers, distributors and businesses introducing eligible skincare, haircare, personal care, makeup or fragrance products to the Malaysian market. We can also assist in coordinating enquiries relating to product variants, notification renewal and changes to product information, subject to the agreed service scope.The Cosmetic Notification Holder remains responsible for the accuracy of declarations and the product’s ongoing compliance, including its formulation, safety, claims, labelling and Product Information File. Notification is subject to NPRA’s applicable requirements and regulatory action.

Related Departments / Regulatory Bodies ​

• National Pharmaceutical Regulatory Agency (NPRA).
• Pharmaceutical Services Programme, Ministry of Health Malaysia.
• Director of Pharmaceutical Services.
• Cosmetic Notification Holder (CNH).
• Product owner, manufacturer and importer, where applicable.
• Companies Commission of Malaysia (SSM).
• Royal Malaysian Customs Department, where applicable.
• Department of Islamic Development Malaysia (JAKIM) or the relevant halal certification authority, where halal certification is sought.
• Testing laboratory or technical consultant, where required.
  

License Name ( Bahasa Malayu )

• Notifikasi Kosmetik dengan National Pharmaceutical Regulatory Agency (NPR
  

Application Scenarios & Business Necessity

• A business plans to introduce a new cosmetic product in Malaysia.
• A brand owner intends to manufacture a cosmetic product through an appointed manufacturer.
• A company plans to import an overseas cosmetic product for the Malaysian market.
• An importer or distributor needs to coordinate notification with the authorised product owner.
• A business plans to sell skincare, haircare, makeup or other eligible cosmetic products.
• A company is introducing additional product variants that require notification.
• A Cosmetic Notification Holder needs assistance coordinating a notification renewal.
• A business needs to review whether changes to product information require an amendment or a new notification.
• A company requires assistance coordinating product, manufacturer and applicant information.
• A business needs support responding to an NPRA enquiry or organising requested documentation.
• An online seller wants to verify that a cosmetic product has a valid notification before selling it.

Important Rules & Compliance Standards

• The product must first be assessed to determine whether it falls within the cosmetic category under the applicable requirements.
• The CNH must meet NPRA’s local entity requirements and be responsible for placing the product on the Malaysian market.
• Where the CNH is not the product owner, the relevant authorisation from the product owner must be available.
• The CNH must notify the product before undertaking activities requiring a valid cosmetic notification.
• Product ingredients, formulation, intended use, labelling and claims must comply with the applicable cosmetic requirements.
• Cosmetic products must not make prohibited medicinal claims or contain prohibited substances.
• The CNH must maintain a Product Information File (PIF) and make it available to the authorities as required.
• The CNH is responsible for the accuracy of the submitted information and for ongoing product compliance after notification.
• Product changes must be assessed because some changes may require an amendment while others may require a new notification.
• A notification number is not evidence that NPRA has approved every safety or performance claim made for the product.
• NPRA’s FAQ states that notification is valid for two years and renewal should be made no later than one month before expiry.
• Product testing, PIF preparation, technical assessment, translation, manufacturer charges and official fees are separate unless stated in the quotation.
  

Compound & Legal Penalties

• Notification submission may be rejected if the product or information does not comply with the applicable requirements.
• The notification may be cancelled if the product is found to be non-compliant.
• The CNH may be required to stop supply, recall or dispose of affected products, subject to the authority’s direction.
• Warning notices, investigation or other regulatory action may be taken where applicable.
• Supplying, selling, importing or manufacturing a cosmetic without the required valid notification may constitute an offence.
• False declarations or non-compliant ingredients, labelling or claims may result in enforcement action.
• Legal proceedings and penalties may apply depending on the specific offence and applicable law.
• Additional costs may arise for product recall, testing, correction of labels or further submissions.
• The amount of any compound or penalty depends on the offence and applicable legal provisions. It should be confirmed with the relevant authority for the specific case.

Frequently Asked Question