Country · Africa
Pharmaceutical exports to Rwanda, ready for Rwanda FDA registration
Progene Pharma supplies Rwandan importers, wholesalers, hospital suppliers and tender suppliers with generic medicines we manufacture in a WHO-GMP certified facility. We prepare the dossier, the COPP and the samples the Rwanda Food and Drugs Authority asks for, pack for the road inland, and ship through Mombasa or Dar es Salaam.
- Regulator
- Rwanda FDA
- Labels
- English, French on request
- Stability
- Zone IVb, 30 °C / 75% RH
- Route in
- Mombasa or Dar es Salaam
The Rwandan medicines market in brief
Rwanda is a small, landlocked and well-organised country in East Africa with a strong record on public health. Its medicines arrive by sea through Mombasa in Kenya or Dar es Salaam in Tanzania and then by road, and it imports almost all of the medicines it uses.
Malaria, HIV and tuberculosis are managed through national programmes, antibiotics and pain medicines are in steady demand, and diabetes and high blood pressure are growing in Kigali. A community-based health insurance scheme covers most of the population, which has widened access to essential medicines.
Public health facilities are supplied mainly through the medical procurement and production division of the national biomedical centre, while private importers, pharmacies and hospitals buy alongside it. Rwanda is a member of the East African Community and takes part in its joint assessment of dossiers.
Medicines we supply to Rwanda
These are the medicines Rwandan distributors ask us for most. We make any human formulation to your specification, under your brand. See all human formulations
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Antimalarials
Artemether and lumefantrine tablets, dispersible tablets and dry syrup, and artesunate injection, for pharmacies, clinics and malaria programmes.
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Antibiotics
Amoxicillin, amoxicillin and clavulanic acid, azithromycin, ciprofloxacin, cefixime and ceftriaxone injection, in adult and paediatric forms.
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Pain and fever
Paracetamol, ibuprofen and diclofenac in tablets, suspensions and injections, the fastest-moving products in community pharmacies.
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HIV and tuberculosis
Antiretrovirals such as lamivudine and zidovudine, and rifampicin, isoniazid, ethambutol and pyrazinamide, for national programmes and treatment centres.
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Diabetes and blood pressure
Metformin, glimepiride, amlodipine, losartan and atorvastatin, as long-term conditions become more common in Kigali, Huye and Musanze.
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Deworming and child health
Albendazole for school deworming, and oral rehydration salts with zinc for children with diarrhoea.
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Mother and child health
Iron with folic acid for pregnancy, vitamin B complex, vitamin D3 and paediatric syrups.
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Hospital supplies
IV fluids, injectable antibiotics, anaesthetics and analgesics in hospital and tender packs.
Rwanda FDA registration, step by step
A medicine cannot be imported, sold or distributed in Rwanda until the Rwanda Food and Drugs Authority (Rwanda FDA) 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 registered in Rwanda, usually the importer or distributor, acting as the local agent of the manufacturer. It applies to the Rwanda FDA.
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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 CTD dossier with Zone IVb stability data, the WHO-format COPP, the GMP certificate and the samples. We prepare all of these.
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04
Rwanda FDA reviews it
The Rwanda FDA assesses the dossier and may ask questions, which we answer with you. A dossier can also go through the East African Community's joint assessment, which reviews one file for several partner states.
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05
Samples and inspection
The samples are tested, and the Rwanda FDA may inspect the manufacturing site or rely on its GMP certification.
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06
Registration and renewal
On approval the Rwanda FDA 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 Rwanda FDA updates its requirements from time to time, so check the current guidelines with Rwanda FDA or your regulatory agent. Many importers register a few products first and add more as orders grow.
Who does what when you import into Rwanda
A clear split of the paperwork, so nothing falls between the importer and the manufacturer.
Your company handles
- The Rwanda FDA application, as the registered local agent
- The licences your business needs to import and wholesale medicines
- The Rwanda FDA import permit for each consignment
- The customs declaration with the Rwanda Revenue Authority, through your clearing agent
- Transit bonds and the road journey inland
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 Rwanda FDA's questions during review
Made for Rwandan 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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Built for the climate
Stability studies at 30 °C and 75% relative humidity (Zone IVb), the condition East African authorities ask for, with alu-alu or PVDC blisters and sealed bottles for humid conditions.
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Labels the Rwanda FDA accepts
English cartons and leaflets that carry the registration number, batch number, manufacture and expiry dates, storage conditions and the other details the Rwanda FDA requires. We can add French text where your customers need it.
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Packs for every channel
Pharmacy packs, hospital packs and tender packs in the quantities the national procurement division, hospitals and pharmacies buy.
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Cartons for the long road
Strong outer cartons and palletised loads for the road journey of well over a thousand kilometres from the coast, where loads sit in heat and handling is rough.
Shipping to Rwanda
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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Mombasa
The usual route, by sea and then by road along the northern corridor through Kenya and Uganda to Kigali
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Dar es Salaam
The alternative route, by sea and then by road through Tanzania on the central corridor
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Kigali
By air to Kigali 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 Rwanda FDA permit, transit documents and customs declaration from your side
Where Rwandan distributors sell
The same registered product moves through several channels, and each needs its own pack.
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Public health supply
The national medical procurement division supplies public hospitals and health centres, buys through tenders, and asks for the full document set.
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Pharmacies and private importers
Importers in Kigali supply pharmacies and clinics with branded packs of the fast-moving generics.
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Hospitals and health networks
Referral hospitals, private clinics and faith-based health networks buy in hospital packs.
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Regional supply
Some importers supply neighbouring Burundi and eastern DR Congo, and need consistent labelling and documents.
Questions about supplying Rwanda
Something else? Email [email protected].
Do you export medicines to Rwanda?
Yes. Progene Pharma manufactures generic medicines in a WHO-GMP certified facility and supplies them to importers, wholesalers, hospital suppliers and tender suppliers in Rwanda.
Can you help us register products with Rwanda FDA?
Yes. Progene Pharma prepares the documents Rwanda FDA registration needs: a CTD dossier with Zone IVb stability data, the WHO-format COPP, the GMP certificate, the letter of authorisation and samples for testing. Your Rwandan company submits the application, and we answer Rwanda FDA's questions with you.
Do I need a local company to register and import?
Yes. The Rwanda FDA registers a medicine through a company registered in Rwanda, usually the importer or distributor, which must also hold the licences to import and wholesale medicines. Check the current requirements with the Rwanda FDA.
How long does Rwanda FDA 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 Rwanda FDA's questions helps. Many importers register a few products first and add more as orders grow.
Which documents does Rwanda FDA ask for?
The usual set is a CTD dossier, a COPP, a GMP certificate, stability data, a letter of authorisation, product samples and artwork. Rwanda FDA updates its requirements from time to time, so confirm the current list with Rwanda FDA or your regulatory agent. We tell you what we can provide with your quotation.
Can the dossier be assessed for several East African countries at once?
The East African Community runs a joint assessment that reviews one dossier for several partner states, which can save time if you plan to sell in Kenya, Uganda or Tanzania as well. Tell us the countries and we will confirm how to prepare the file.
How do medicines reach Rwanda?
Rwanda is landlocked, so shipments go by sea to Mombasa or Dar es Salaam and then by road to Kigali, under a transit bond. Your clearing agent handles transit and customs, and we confirm the schedule with your quotation.
Can you supply the national procurement division?
Yes. Progene Pharma supplies tender packs and the documents public tenders usually ask for. Send us the tender requirements and we will confirm what we can provide.
What must the packs carry for Rwanda?
English text, French where you want it, the Rwanda FDA registration number, batch number, manufacture and expiry dates, storage conditions and the other details required. 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 Rwanda?
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 Rwanda?
Progene Pharma ships by sea from Nhava Sheva (JNPT) near Mumbai to Mombasa or Dar es Salaam, with onward road freight to Kigali, or by air to Kigali 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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- [email protected]
- Phone
- +91 22 49793146
- +91 90829 70494