DRUG ADMINISTRATION SECTION

Drug Administration Section (DAS) is one of the regulatory arms of the Department of Pharmaceutical Services that regulates medicinal products and cosmetic products in Brunei Darussalam.  Its main objective is to ensure medicinal products meet the quality, efficacy and safety requirements and the cosmetic products meet the quality and safety criteria before they are marketed in Brunei Darussalam.

Currently there are 4 units in operation namely:

• Drug Registration Unit
• Cosmetic Unit
• Good Manufacturing Practice (GMP) & Licensing Unit
• Surveillance Unit. 
  
   
  
  The Medicines Order, 2007 and its related listed legislations are administered to execute various functions of the section.

• Medicines (Licensing, Standard Provision and Fees) Regulations, 2010;
• Medicines (Labelling) Regulations, 2010; and
• Medicines (Cosmetic Products) Regulations, 2007).
   

DAS will also be responsible for the processes pertaining to regulation of Traditional Medicine and Health Supplement (TMHS) products in the future.  Comprehensive TMHS control will be implemented in phases once the legal and physical infrastructure; and manpower resources are in place.

Roles and Functions

The main activities of Drug Administration Section include:

1. 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:
• Registration of medicinal products
• Variation to a registered medicinal product
• Renewal of medicinal product registration
• Import Permit for importation of unregistered medicinal products
• Licence to import a registered medicinal product by non-product licence holder (on consignment basis)
• Import Licence and Wholesaler's Licence for medicinal products; and
• 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 monitoring their conformance to recognised international standards.

LOCATION

Department of Pharmaceutical Services

2^nd Floor, Spg. 433, Rimba Highway,

Kg. Madaras, Mukim Gadong A,

Brunei Darussalam.

CONTACT NO.

OPERATING HOURS

SCHEDULES