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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 – 11.45am
1.45pm – 4.00pm

Submission of Applications are made by appointment basis

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Application Forms and Guidelines:

  • APPLICATION FORM (PART 1) - ADMINISTRATIVE DATA & PRODUCT INFORMATION
  • (PART II) SECTION 1 QUALITY REQUIREMENTS OF THE DRUG SUBSTANCE
  • (PART II) SECTION 2 QUALITY REQUIREMENTS OF THE DRUG PRODUCT
  • APPLICATION FORM FOR APPEAL OF REJECTED MEDICINAL PRODUCTS

Guidelines to Application for Registration:

  • GUIDE TO APPLICATION FOR REGISTRATION OF MEDICINAL PRODUCTS (3RD EDITION, DEC 2012)


Checklist for submitting Applications:

  • GUIDE TO APPLICATION FOR REGISTRATION OF MEDICINAL PRODUCTS (3RD EDITION, DEC 2012)


GUIDE TO APPLICATION FOR REGISTRATION OF MEDICINAL PRODUCTS (3RD EDITION, DEC 2012)

Poisons license renewal - Form B:


Complaint and Recall forms:

 

Application forms for Drug Registration:

Application checklists for Drug Registration:

Application form for Appeal for Registration of Rejected Medicinal Products
(Form No: BDMCA/DPS/Appeal/01)     updated on 18.02.2013 
 

Application form for Variations to a Registered Medicinal Product
(Form No: BDMCA/DPS/Vartn/02)     updated on 18.02.2013 
 

Application Form for Renewal of Registration for Medicinal Product  
  updated on 18.02.2013 

 

Application Form for an Import Permit of a Medicinal Product on Consignment Basis
 

Checklist for Submission of Application for an Import Permit of a Medicinal Product on Consignment Basis
 

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