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Importation, Manufacture, Sale and Supply of Medicinal Products into 
Brunei Darussalam


In Brunei Darussalam, the importation, manufacture and sale of medicinal and supply products is regulated under:

  • Medicines Order, 2007;
  • Medicines (Labelling) Regulations, 2010;
  • Medicines (Licensing, Standard Provisions and Fees) Regulations, 2010;
  • Misuse of Drug Regulations

All pharmaceutical importers, wholsalers and manufacturers must comply with all the relevant provisions under the Medicines Order and its regulations, which include registration of medicinal products to ensure all medicinal products marketed in Brunei Darussalam are safe, efficacious and of good quality


REGISTRATION OF MEDICINAL PRODUCT

As prescribed by section 10 of the Medicines Order - no person shall manufacture, sell, supply or import any medicinal product unless:

  1. The medicinal product is a registered product;
  2. That person holds the appropriate license required and issued under this order

REGISTRATION PROCESS OF A MEDICINAL PRODUCT

​Steps ​Client's Charter (TPOR)
​
Step 1:
  • Submission of application form with complete documentation
​
30 Minutes
​
Step 2:
  • Assessment by Product Regulation Team and Drug Registration Committee (DRC)
    Generic:
    New Chemical Entity / Vaccines / Biologics :
​


132 Working days
 246 days
​
Step 3:
  • Endorsement by Brunei Darussalam Medicines Control Authority (BDMCA)
​
45 Working days


Note:
  1. Product license is valid for 5 years and can be renewed
  2. Product License Holder must inform the authority of any changes to the registered product particulars prior to implementation