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We are the Drug Administration team

​What we do:

Implementing the drug registration system and cosmetic notification procedure through assessment of technical data and information received from applicants. The drug registration system encompasses the evaluation of documents submitted for application of:

  1. Registration of medicinal products
  2. Variation to a registered medicinal product
  3. Renewal of medicinal product registration
  4. Import Permit for importation of unregistered medicinal products
  5. Licence to import a registered medicinal product by non-product licence holder (on con-signment basis)
  6. Import Licence and Wholesaler's Licence for medicinal products; and
  7. Licence to manufacture /assemble medicinal products.   

The Cosmetic Notification Procedure includes:
  • Notification of Cosmetic Products
  • Amendment of a notified cosmetic product; and
  • Renewal of a notified cosmetic product.
  • Investigating complaints regarding safety, quality or efficacy of registered medicinal products; and the safety and quality of notified cosmetic products.
  • Monitoring the quality of registered medicinal products and notified cosmetic products through random sampling of the products in the market, evaluation ​of the samples, and lab testing of the samples in collaboration with the Pharmacy Enforcement Section and the Drug Quality Control Section.
  • Licensing of local medicinal product manufacturers, importers and wholesalers, and moni-toring their conformance to recognised international standards.
 
Other notes:
We are a team of there are 4 units, namely:
  • Drug Registration Unit
  • Cosmetic Unit
  • Good Manufacturing Practice (GMP) & Licensing Unit
  • Surveillance Unit.  

How to reach us:
Department of Pharmaceutical Services
2nd Floor, Spg. 433, Rimba Highway,
Kg. Madaras, Mukim Gadong A,
Brunei Darussalam.

Telephone number: +6732393298 / 2393301 / 2393230 Ext 218/ 219
Fax number: +6732393297