DRUG Administration SECTION  

Schedules:

1. Submission of application for drug registration:
   Monday and Wednesday (by appointment only)

2. Cosmetic product notification:
   • Submission of cosmetic product notification form: Tuesday and Thursday (7.45 am – 12 noon)
   • Payment: (working days – 7.45 am – 12 noon)

Introduction:
Drug Administration Section (DAS) is one of the regulatory arms of the Department of Pharmaceutical Services. The main objectives of DAS are to ensure that drugs used in Brunei Darussalam are safe, effective and of acceptable quality; and to ensure cosmetic products available in the country meet safety and quality criteria. With this objective it will further strengthen the department’s drug regulatory control in Brunei Darussalam.

Currently there are 2 units under DAS in operation. They are:

1. Registration Unit

2. Cosmetic Unit

Apart from these, DAS will also be eventually responsible for the GMP & Licensing; and surveillance programme. These functions will be implemented in phases once the legal and physical infrastructure and resources are in place.

Personnel:

• 1 Principal Pharmaceutical Chemist;

• 1 Senior Pharmaceutical Chemist;

• 4 Pharmaceutical Chemists;

• 4 support staff (1 Assistant Executive Officer and 3 clerical staff)

Main functions and activities:

Drug Registration Unit:
One of the main functions is implementing the drug registration system with the objective of ensuring pharmaceutical products imported, manufactured, supplied and sold are safe, efficacious and of acceptable quality for use in Brunei Darussalam. However, before comprehensive drug registration system is introduced with proper legislative support, provisional drug registration (PDR) was started since April 2006. The implementation of PDR is carried out in phases according to the different classes of drugs.

Provisional Drug Registration Committee:
Provisional Drug Registration Committee (PDRC) was established in August 2007 and meet monthly to discuss the submitted PDR applications which have been completely evaluated including variation applications. PDRC also discussed matter pertaining to the issues raised in the implementation of provisional drug registration.

Cosmetic Unit:
Cosmetic unit is responsible for handling the cosmetic notification procedure in-line with the Medicines (Cosmetic Products) Regulations, 2007 and ASEAN Cosmetic Directive (ACD). The notification procedure involves an upfront declaration of compliance by the responsible person/ company before placing the product in the local market. The responsible company/ person has to ensure that their cosmetic product complies with the safety and quality criteria. The notification procedure for cosmetic products was implemented on 03 June 2008. This unit is headed by the Chief Scientific Officer.