2.0 Cosmetic Notification

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2. COSMETIC NOTIFICATION

 

2.1 Who Shall Submit for Cosmetic Notification  
2.2 Responsibility of the CNH  
2.3 Submission of Notification  
2.4 Language  
2.5 Privacy Markings  
2.6 Fee  
2.7 Notification Validity Period  
2.8 Manufacture or Importation of Product  
2.9 Changes in Notification Particulars  
2.10 Notification Number  

 

APPLICATION PROCEDURES

 

2.1 Who Shall Submit for Cosmetic Notification

 

The CNH is responsible to notify the DPS prior to manufacture, sell, supply, import or possess any cosmetic product.

 

2.2 Responsibility of the CNH

 

CNH is responsible to ensure that:

  1. All transactions with NPRA shall be carried out by CNH’s appointed person(s).
  2. Notified product meets all stipulated regulations and guidelines for cosmetic product.
  3. Product Information File (PIF), including updated information/document on product quality, safety and claimed benefit is available and accessible upon request.
  4. If and when directed by NPRA for product recall, CNH must ensure all affected cosmetic products are recalled from the market and discontinued from selling or supplying the product. Product distribution record must be properly kept for recall purpose.
  5. Change(s) to notified product particulars is submitted accordingly.
  6. Manufacturer (and assembler, where applicable) of the cosmetic product is compliant to Cosmetic Good Manufacturing Practice (cGMP).
  7. In the incidence of serious adverse event, CNH shall report to NPRA appropriately.  
  8. Particulars given for product notification are truthful where all data and information of relevance to the notification has been provided.
  9. Each consignment continues to meet all legal requirements and conforms to standards and specifications declared for the product.
  10. When a product failed to conform to any of the standards or specifications declared for the product, CNH cannot place reliance on the acceptance of the product notification in any legal proceedings.
  11. Correspondence details such as company’s name, address, contact person, telephone number, fax number and email shall be kept updated.
  12. Cessation of the authorisation of the CNH shall be informed to the NPRA in writing.
  13. Any decision to withdraw the notification of a product shall be informed to the NPRA, with reasons

2.3 Submission of Notification

All submission for notification shall be done online through NPRA Quest system via NPRA’s website at http://npra.moh.gov.my.

  1. Quest Membership Registration

A CNH must first register for a Quest membership. A detailed guide for Quest membership registration is available on NPRA’s website. CNH may also refer to Frequently Asked Questions (FAQ) section on Quest System at NPRA’s website for more information. 

For information on charges and validity of the membership, please refer to Annex I, part 3: Charges for Quest Membership.

The CNH shall be responsible for any act of fraudulence or misuse of Quest membership.

The NPRA reserves the rights to approve or reject any application for the Quest membership.


ii. Notification of Cosmetic Products

For online submission of notification of cosmetic product, CNH must complete the notification form on the Quest system for each cosmetic product and variant, if any and proceed with the payment to the NPRA.

A step by step guidance on online notification submission is described further in Annex I, part 4: Guide Manual for Quest Online Submission of Cosmetic Notification

A general workflow of a notification process is shown in Figure 1.

 

2.4. Language

Any document and material submitted to NPRA must be in Bahasa Malaysia or English. Translated version from other languages must be endorsed or authorised. 

 

2.5 Privacy Markings

 All Information submitted to the NPRA is deemed confidential, although it is not marked as such by the CNH.

 

2.6 Fee

The processing fee for notification of a cosmetic product is RM50.00 for each product (and variant, if any).

The processing fee for renewal of notification of a cosmetic product is also RM50.00 for each product (and variant, if any).

Any payment made shall NOT be REFUNDABLE once the application has been submitted and payment is confirmed. Please refer to Annex I, part 4: Guide Manual for Quest Online Submission of Cosmetic Notification for acceptable mode of payment.

 

 


Figure 1: Workflow of a notification process

 

 

 

2.7 Notification Validity Period

The notification of a cosmetic product shall be valid for 2 years. The renewal should be done no later than 1 month prior to notification expiry.

 

2.8       Manufacture or Importation of Product

CNH may manufacture or import the cosmetic product upon receipt of authorisation given in the Notification Note from the DPS. CNH may generate the Notification Note immediately from the Quest system after confirmation of payment by NPRA subject to meeting all notification requirements.

 

2.9       Changes in Notification Particulars

Any subsequent changes to the particulars of the notified cosmetic product must be submitted to the NPRA. There are two types of changes:

Type 1 change:

  • Changes that only require amendments to the current notification. No charge is imposed and the notification number remains the same.

Type 2 change:

  • Changes that require a new notification and is subjected to RM 50.00 processing fee. A new notification number will be issued to the product.

Please refer to Annex I, part 5 for Illustrative List of Types of Changes for Notified Product.

 

 

2.10    Notification Number

Notification number is unique for each product and its variant (if any) in the format as below:

NOTyymmxxxxxK (y: year, m: month, x: serial number)

CNH is responsible to ensure the maintenance of valid notification number for product in the market. The existing notification number will be retained for product notification that has been renewed prior to expiry date. A new notification number will be generated for product that is not renewed within the given timeline and for product that has undergone changes requiring new notification.

 

 


National Pharmaceutical Regulatory Agency (NPRA)
Lot 36, Jalan Universiti, 46200 Petaling Jaya, Selangor, Malaysia.
  • Email: npra@npra.gov.my
  • Phone: +603-7883 5400
  • Fax: +603-7956 2924, +603-7956 7075

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