Medicinal products
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The medicinal products manufactured, sold, supplied or imported into Brunei Darussalam are regulated under the Medicines Order, 2007 and its related regulations.
The Brunei Darussalam Medicines Control Authority (BDMCA) through the Department of Pharmaceutical Services is the Authority responsible for making decisions and recommendations in relation to any matter related to any registration, the issuance of any licences or the listing of any medicinal product.
Since mandatory implementation of drug registration system in July 2012, the pharmaceutical importers, wholesalers and manufacturers must register a medicinal product before the product can be marketed in Brunei Darussalam.
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CONTACT US
Drug Registration Unit
Product Regulation Section
Department of Pharmaceutical Services
Second Floor, Spg 433,
Building of the Department of Pharmaceutical Services
Kg Madaras, Rimba Highway,
Brunei Darussalam
Telephone: 2393298 / 2393301 ext 225
Email: drugregistration@moh.gov.bn
drugvariation@moh.gov.bn
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OPENING HOURS
Monday – Thursday & Saturday
8.00 am – 11.45 am
1.45 pm – 4.00 pm
Submission of Application for Registration of Medicinal Products
Submission of Application for Renewal of Registration of Medicinal Products
Monday 8am - 11am
Submission of Application for Import Permit of Medicinal Products with Special Approval (SMP )
Submission of Application to Import a Registered Medicinal Product by Non-Product Licence Holder (on consignment basis )
Submission of Application for Minor Variation (MiV-N) to Registered Medicinal Products
Tuesday 8 am – 11 am
Submission of Application for Variation to Registered Medicinal Products (MaV / MiV-PA)
Wednesday 8 am – 11 am
Submission of Applications are made by appointment basis
