Roles and Functions

Introduction:
The Pharmacy Enforcement Section regulates the importation and sale of pharmaceutical products through the enforcement of the Poisons Act and the Misuse of Drugs Act. These two acts are specifically for regulating products containing scheduled poisons and Controlled Drugs as listed under the Poisons Act and the Misuse of Drugs Regulations respectively.

The Poisons Act is enforced by the Ministry Of Health through the Pharmacy Enforcement Section under the Department of Pharmaceutical Services. The Misuse of Drugs Act which control drug abuse is enforced by Narcotics Control Bureau whereas the Misuse of Drug Regulations is jointly enforced by the Pharmacy Enforcement Section and Narcotics Control Bureau.

In addition to the above two pharmacy legistations, namely the Poisons Act and the Misuse of Drug Act, Brunei Darussalam is also a signatory member to the three international drug conventions:

1. Single Convention on Narcotic Drugs (1961)
   
   
2. Convention on Psychotropic Substances (1971)
   
   
3. United Nations against Illicit Traffic in Narcotic Drugs & Psychotropic Substances (1988)
   

Being in line with those three conventions, all the substances listed under the 1961 Convention are controlled under the Misuse of Drug Act and all those substances listed under the 1971 and 1988 conventions are controlled under the Poisons Act.

Future pharmacy legislations would include Registration of Pharmacists Order and the Medicines Order. The Registration of Pharmacists Order has already been passed but not enforce yet. This Act controls the standards and practices of Pharmacists in Brunei Darussalam. The Medicines Order which covers drug registration and control of medical advertisement is in process of drafting by the Attorney General’s Chambers.

Currently this section is manned by one officer, five medicines inspectors and one trainee medicines inspector.

1. Inspection and Licensing Unit
   
   
   • Processing application of poisons licences
   • Processing application for renewal of poisons licences
   • Inspection of premises
   • Inspection at entry points
     
     

   Inspection of premises for processing application and renewal of poisons licences is carried out by this unit. All licensed premises are inspected on a regular basis and their inventories checked in order to ensure compliance of the Poisons Act. Pharmaceutical wholesaler, medical and dental clinics and any companies dealing with poison chemicals are subject to inspection upon applying or renewal of their poisons licences.

   
   This unit also carries out inspection to any outlets that sell medicines such as supermarket, shops and mini marts in the rural areas. Personal import of medicines are also inspected at the customs in post office and selected consignment containing medicines are also subject to inspection at airport cargo and passenger terminal.

   
   
2. Poisons Unit
   
   
   • Control on import of poisons
   • Control on sale and supply of poisons
   • Computerised data entry and storage
   • Documentation of banned medicines
   
   In collaboration with Royal Customs and Excise, this unit controls the import of poisons through the endorsement of Customs declaration forms. All poisons imported are stored in a computerised database for future reference and information. This unit also carries out regular inspection of medical halls and any medical outlets.
   
   
3. Non-Poisons Unit
   
   
   • Application for import of non-poison
   • Documentation of banned medicines
   • Inspection of unlicenced premises
   • Post Marketing Surveillance
   
   Application for approval to import traditional medicines and health supplement is processed by this unit. All items either approved or prohibited for import are recorded in a computerized database. Inspections are also conducted for the sale of adulterated traditional medicines and counterfeit pharmaceuticals. Samples of traditional medicines collected from the markets are tested for the presence of controlled substances under the on going poisons surveillance program.
   
   
4. Narcotics, Psychotropics and Precursors Unit
   
   
   • Processing application of import licences
   • Monitoring the distribution of controlled substances
   • Data collection for International Narcotics Control Board
   
   This unit monitors all the import and distribution of narcotics and psychotropic substances. Application for licence to import these substances is processed in accordance to the quota allocated to Brunei Darussalam by the International Narcotics Control Board. Data for all narcotics, psychotropic substances and precursor chemicals are collected and compiled for reporting to the said board.
   
   Objectives:
   
   
   • To safeguard public health through the enforcement of the legislative control of pharmaceuticals under the Poisons Act and the Misuse of Drugs Regulations and administrative control of tradisional medicines, health supplements and any other products for medicinal use.
   
   
   • To ensure proper use of substances which can be abused and to prevent their diversion from legitimate trade to illicit market.