Country · Southeast Asia
Pharmaceutical exports to Brunei, ready for Ministry of Health registration
Progene Pharma supplies Bruneian importers, distributors and hospital suppliers with generic medicines we manufacture in a WHO-GMP certified facility. We prepare the dossier, the COPP and the samples that Pharmaceutical Services at the Ministry of Health asks for, label in English, and ship to Muara.
- Regulator
- Pharmaceutical Services, Ministry of Health
- Labels
- English
- Stability
- Zone IVb, 30 °C / 75% RH
- Main port
- Muara
The Bruneian medicines market in brief
Brunei is a small, wealthy market on the island of Borneo, with a well-funded public health system. It imports almost all of the medicines it uses, and the Ministry of Health buys for government hospitals and clinics.
Chronic care medicines for diabetes, high blood pressure and heart disease sell in large volumes, alongside antibiotics, pain medicines, gastric products and supplements. Private pharmacies and clinics buy through a small number of licensed importers.
Brunei is an ASEAN member and uses the ASEAN Common Technical Dossier (ACTD) format. As the market is small, many importers add Brunei after registering in larger Southeast Asian markets.
Medicines we supply to Brunei
These are the medicines Bruneian distributors ask us for most. We make any human formulation to your specification, under your brand. See all human formulations
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Generic medicines for pharmacies
Analgesics, antihistamines, gastric medicines and everyday prescription generics in the strengths and packs pharmacies sell.
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Antibiotics and infections
Amoxicillin, amoxicillin and clavulanic acid, azithromycin, ciprofloxacin, cefixime and ceftriaxone injection, for clinics and hospitals.
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Pain and fever
Paracetamol, ibuprofen and diclofenac in tablets, suspensions and injections.
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Diabetes and heart care
Metformin, glimepiride, amlodipine, losartan and atorvastatin, as long-term conditions become a larger share of prescriptions in Bandar Seri Begawan, Kuala Belait and Seria.
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Stomach and allergy
Omeprazole, pantoprazole, cetirizine, montelukast and cough syrups, for everyday pharmacy sale.
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Hospital and tender supplies
IV fluids, injectable antibiotics, anaesthetics and analgesics in hospital packs for tenders.
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Vitamins and supplements
Multivitamins, vitamin D3, omega-3, probiotics and protein products for pharmacies, health stores and online sellers.
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Herbal and personal care
Herbal products, creams, washes, shampoos and soaps under your brand, with the ingredient lists your authority requires.
MoH registration, step by step
A medicine cannot be imported or sold in Brunei until Pharmaceutical Services at the Ministry of Health has registered it. This is the usual route for a finished pharmaceutical product made abroad.
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01
A local company applies
The registration is held by a company established in Brunei that holds the right licences, usually the importer or distributor, acting for the manufacturer. It applies to the ministry.
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02
The manufacturer authorises it
The manufacturer gives the applicant a letter of authorisation that names the product and the company, which we provide.
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03
The dossier goes in
The applicant submits the ACTD dossier with stability data, the WHO-format COPP, the GMP certificate and the samples. We prepare the manufacturer's documents.
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04
MoH reviews it
The ministry assesses the dossier and may ask questions, which we answer with you.
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05
GMP evidence and samples
The ministry checks that the manufacturing site complies with GMP, from the documents or an inspection, and may test samples.
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06
Registration and renewal
On approval the ministry issues a registration and a registration number, which goes on every pack. The registration is valid for a fixed period and is renewed before it expires.
Registration takes from several months to more than a year, and MoH updates its requirements from time to time, so check the current guidelines with MoH or your regulatory agent. Many importers register a few products first and add more as orders grow.
Who does what when you import into Brunei
A clear split of the paperwork, so nothing falls between the importer and the manufacturer.
Your company handles
- The ministry application, as the registered local company
- The licences your business needs to import and distribute medicines
- The import permit for each consignment
- The customs declaration, through your clearing agent
- Payment, and clearance at the port
Progene Pharma handles
- The CTD dossier, stability data and samples
- The COPP, the GMP certificate and the letter of authorisation
- A Certificate of Analysis for every batch
- Labels and leaflets with your registration number
- Invoice, packing list and certificate of origin
- Answers to MoH's questions during review
Made for Bruneian conditions
Heat, humidity, long journeys and several languages: what a medicine needs to stay good from the port to the patient.
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English labels
Cartons and patient leaflets in English, with the registration number, batch number, expiry date and storage conditions the ministry requires, and an approved proof before printing.
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Built for the climate
Stability studies at 30 °C and 75% relative humidity (Zone IVb), with moisture-resistant blisters and bottles for the humid conditions.
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Packs for every channel
Pharmacy packs, clinic packs and hospital packs in the quantities importers and the government buy.
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Documents that match the file
The COA, the COPP and the GMP certificate are prepared to match the dossier exactly, because inconsistencies slow review.
Shipping to Brunei
Orders leave from Nhava Sheva (JNPT) near Mumbai by sea, or by air when they are urgent, with the documents your clearing agent needs.
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Muara
Brunei's deep-water port, with road freight to Bandar Seri Begawan
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Via Singapore
Some cargo is transhipped through Singapore or Port Klang, depending on the schedule
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Bandar Seri Begawan
By air to Brunei International Airport for urgent orders and samples
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Terms and documents
FOB, CFR or CIF, with invoice, packing list, certificate of origin and COA, and the import permit and customs declaration from your side
Where Bruneian distributors sell
The same registered product moves through several channels, and each needs its own pack.
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Government hospitals
The Ministry of Health buys for government hospitals and clinics and asks for the full document set.
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Private clinics and hospitals
Private clinics and hospitals buy through licensed importers.
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Pharmacies
Pharmacies sell branded packs of everyday generics and supplements.
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Importers
A small number of licensed importers hold the registrations and supply the country.
Questions about supplying Brunei
Something else? Email [email protected].
Do you export medicines to Brunei?
Yes. Progene Pharma manufactures generic medicines in a WHO-GMP certified facility and supplies them to importers, wholesalers, hospital suppliers and tender suppliers in Brunei.
Can you help us register products with MoH?
Yes. Progene Pharma prepares the documents MoH registration needs: a CTD dossier with stability data, the WHO-format COPP, the GMP certificate, the letter of authorisation and samples for testing. Your Bruneian company submits the application, and we answer MoH's questions with you.
Do I need a local company to register and import?
Yes. The ministry registers a medicine through a company established in Brunei that holds the right licences, usually the importer or distributor. Check the current requirements with Pharmaceutical Services.
How long does MoH registration take?
It varies by product and by how complete the dossier is, from several months to more than a year. A complete dossier with clear stability data and prompt answers to MoH's questions helps. Many importers register a few products first and add more as orders grow.
Which documents does MoH ask for?
The usual set is a CTD dossier, a COPP, a GMP certificate, stability data, a letter of authorisation, product samples and artwork. MoH updates its requirements from time to time, so confirm the current list with MoH or your regulatory agent. We tell you what we can provide with your quotation.
What is the ACTD?
The ASEAN Common Technical Dossier is the shared registration format that ASEAN countries use for medicines, covering quality, manufacture and stability. Progene Pharma prepares the dossier in the format the ministry accepts, and the ministry may add its own requirements.
Is Brunei worth registering in?
It is a small market, so many importers add it after registering in larger Southeast Asian markets. The dossier you prepare for those can be reused. Tell us your plans and we will say how it fits.
Can you supply Brunei government tenders?
Yes. Progene Pharma supplies tender packs and the product documents public tenders usually ask for, such as the COPP, GMP certificate and COA. Tell us the tender requirements and we will confirm what we can provide.
What must the packs carry for Brunei?
English text, the ministry registration number, batch number, manufacture and expiry dates, storage conditions and the other details ministry requires. We prepare the artwork to match your registration and you approve a proof before printing.
Are your medicines suitable for the climate?
Yes. Products for this market are tested at 30 °C and 75% relative humidity (Zone IVb) and packed in moisture-resistant blisters or bottles, so the shelf life stays valid in hot, humid conditions.
Can you supply tenders in Brunei?
Yes. Progene Pharma supplies tender packs and the product documents tenders usually ask for, such as the COPP, GMP certificate and COA. Tell us the tender requirements and we will confirm what we can provide.
How are orders shipped to Brunei?
Progene Pharma ships by sea from Nhava Sheva (JNPT) near Mumbai to Muara, or by air to Bandar Seri Begawan for urgent orders, on FOB, CFR or CIF terms. We confirm the schedule with your quotation.
What is the minimum order quantity?
It depends on the product, the dosage form and the packaging. We work with large importers and tender suppliers as well as smaller distributors, and confirm the minimum quantity with your quotation.
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Send us your product requirements and target country. Our team will reply with a quotation and next steps.
- [email protected]
- Phone
- +91 22 49793146
- +91 90829 70494