OMC Medical
OMC Medical

 Cosmetics Registration in Brunei

Regulatory Authority:

Brunei Darussalam Medicines Control Authority (BDMCA)

Link for RA:

https://www.moh.gov.bn/Pages/Home.aspx

Local regulation:

Medicines (Cosmetic Products) Regulations, 2007

Who can register :  

  • Importer
  • Manufacturer

Data to be communicated : 

The following documents must be presented with the first Notification:

  • A copy of the company’s certificate of incorporation 
  • A copy of the importer’s and representative’s Brunei Darussalam Identity Card 
  • Letter of authorization for the appointed representative(s)

Details to be filled in the Notification:

  • Brand name 
  • Company changes due to changes in distribution rights 
  • Product types 
  • Product presentation (single product, palettes in a range, etc.) 
  • Intended use
  • Product name
  • Formulation 
  • Manufacturer or assembler (name and address), including the addition of a new manufacturer and assembler
  • Name and address of local company without change of distribution rights 
  • A person representing local company
  • Importers, including the addition of new importers

Process:  

  • The importer must be registered under the Business Names Act (Chapter 92) if he is an individual. He must hold a Brunei Darussalam Identity Card and be based in Brunei Darussalam, and possess adequate knowledge that complies with all regulations specified by the Authority.
  • The cosmetic product notification form can be obtained from the Cosmetic Unit or downloaded from the following website: http://www.moh.gov.bn/medhealthservices/pharmacyservices.htm.
  • The Cosmetic Product Notification Form shall be submitted only ONCE for each cosmetic product. 
  • Completed forms shall be submitted to the Cosmetic Unit, Drug Administration Section, Department of Pharmaceutical Services, Ministry of Health.
  • Each cosmetic product application form would be issued with temporary reference numbers, which would be used for all correspondences before the notification numbers are issued.

Timeframe and fees: 

New Product Notification – $10/ year

Product variant – $10/ year

Palette(s) in a range of one product type – $10 each (first 5 colours)/ year

        $5 each (subsequent colour)/ year

Renewal of Cosmetic Product Notification – $10/ year (3)

Application to amend Cosmetic Product Notification – No charge

Notification validity for one year, 2 years or 3 years.

Each product notification form submitted shall be acknowledged within three working days, and a cosmetic product notification number would be issued for each cosmetic product. 

Application Form(s) for renewal of cosmetic product notifications must be submitted 2 weeks before the expiry of the validity period of the cosmetic product notification acknowledgement letter. 

Additional information:  

Information on the cosmetic product label must be in the English and Malay language or both and must be legible, understandable and memorable. Other languages, if any, may be present on the label.