Country · Africa
Pharmaceutical exports to Zimbabwe, ready for MCAZ registration
Progene Pharma supplies Zimbabwean 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 Medicines Control Authority of Zimbabwe asks for, pack for the long road inland, and ship through Beira, Durban or Maputo.
- Regulator
- MCAZ
- Labels
- English, with the registration number
- Stability
- Zone IVb, 30 °C / 75% RH
- Route in
- Beira, Durban, Maputo
The Zimbabwean medicines market in brief
Zimbabwe is a landlocked country in Southern Africa. Its medicines arrive by sea through Beira or Maputo in Mozambique or Durban in South Africa and then travel inland by road. It has a small local pharmaceutical industry and imports a large share of the medicines it uses.
HIV prevalence is high, so antiretrovirals are bought at scale through national programmes, and malaria, tuberculosis, antibiotics and pain medicines are in steady demand, with diabetes and high blood pressure rising in Harare and Bulawayo. Payment terms and foreign currency need careful planning, and we agree them clearly before an order.
Public health facilities are supplied mainly through the National Pharmaceutical Company, NatPharm, while private importers, pharmacy chains, mission hospitals and NGOs buy alongside it. Zimbabwe also takes part in the ZAZIBONA collaboration, which lets regulators in Southern Africa share the assessment of a dossier.
Medicines we supply to Zimbabwe
These are the medicines Zimbabwean distributors ask us for most. We make any human formulation to your specification, under your brand. See all human formulations
-
Antimalarials
Artemether and lumefantrine tablets, dispersible tablets and dry syrup, and artesunate injection, for pharmacies, clinics and malaria programmes.
-
Antibiotics
Amoxicillin, amoxicillin and clavulanic acid, azithromycin, ciprofloxacin, cefixime and ceftriaxone injection, in adult and paediatric forms.
-
Pain and fever
Paracetamol, ibuprofen and diclofenac in tablets, suspensions and injections, the fastest-moving products in community pharmacies.
-
HIV and tuberculosis
Antiretrovirals such as lamivudine and zidovudine, and rifampicin, isoniazid, ethambutol and pyrazinamide, for national programmes and treatment centres.
-
Diabetes and blood pressure
Metformin, glimepiride, amlodipine, losartan and atorvastatin, as long-term conditions become more common in Harare, Bulawayo and Mutare.
-
Deworming and child health
Albendazole for school deworming, and oral rehydration salts with zinc for children with diarrhoea.
-
Mother and child health
Iron with folic acid for pregnancy, vitamin B complex, vitamin D3 and paediatric syrups.
-
Hospital supplies
IV fluids, injectable antibiotics, anaesthetics and analgesics in hospital and tender packs.
MCAZ registration, step by step
A medicine cannot be imported, sold or distributed in Zimbabwe until the Medicines Control Authority of Zimbabwe (MCAZ) has registered it. This is the usual route for a finished pharmaceutical product made abroad.
-
01
A local company applies
The registration is held by a company registered in Zimbabwe, usually the importer or distributor, acting as the local agent of the manufacturer. It applies to MCAZ.
-
02
The manufacturer authorises it
The manufacturer gives the applicant a letter of authorisation that names the product and the company, which we provide.
-
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.
-
04
MCAZ reviews it
MCAZ assesses the dossier and may ask questions, which we answer with you. A dossier can also go through the ZAZIBONA collaboration, which shares the assessment between several Southern African regulators.
-
05
Samples and inspection
The samples are tested in the national laboratory, and MCAZ may inspect the manufacturing site or rely on its GMP certification.
-
06
Registration and renewal
On approval MCAZ 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 MCAZ updates its requirements from time to time, so check the current guidelines with MCAZ or your regulatory agent. Many importers register a few products first and add more as orders grow.
Who does what when you import into Zimbabwe
A clear split of the paperwork, so nothing falls between the importer and the manufacturer.
Your company handles
- The MCAZ application, as the registered local agent
- The licences your business needs to import and wholesale medicines
- The MCAZ import permit for each consignment
- The customs declaration with the Zimbabwe Revenue Authority, through your clearing agent
- Payment, foreign currency and transit through 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 MCAZ's questions during review
Made for Zimbabwean conditions
Heat, humidity, long journeys and several languages: what a medicine needs to stay good from the port to the patient.
-
Built for the climate
Stability studies at 30 °C and 75% relative humidity (Zone IVb), the condition African authorities ask for, with alu-alu or PVDC blisters and sealed bottles for humid conditions.
-
Labels MCAZ accepts
English cartons and leaflets that carry the registration number, batch number, manufacture and expiry dates, storage conditions and the other details MCAZ requires.
-
Packs for every channel
Pharmacy packs, hospital packs and tender packs in the quantities NatPharm, mission hospitals, pharmacies and NGOs buy.
-
Cartons for the long road
Strong outer cartons and palletised loads for the road journey of several hundred kilometres from the coast, where loads sit in heat and handling is rough.
Shipping to Zimbabwe
Orders leave from Nhava Sheva (JNPT) near Mumbai by sea, or by air when they are urgent, with the documents your clearing agent needs.
-
Beira
The usual route, by sea and then by road along the Beira corridor to Harare
-
Durban and Maputo
The alternative routes, through South Africa or Mozambique, depending on the schedule
-
Harare
By air to Robert Gabriel Mugabe International Airport for urgent orders and samples
-
Terms and documents
FOB, CFR or CIF, with invoice, packing list, certificate of origin and COA, and the MCAZ permit, transit documents and customs declaration from your side
Where Zimbabwean distributors sell
The same registered product moves through several channels, and each needs its own pack.
-
Public health supply
NatPharm supplies public hospitals and clinics, buys through tenders, and asks for the full document set.
-
NGOs and donor programmes
International organisations buy HIV, malaria and tuberculosis products in bulk and expect complete documentation.
-
Pharmacies and private importers
Importers in Harare and Bulawayo supply pharmacies and clinics with branded packs of the fast-moving generics.
-
Mission and private hospitals
Mission hospitals and private clinics buy in hospital packs, often under annual contracts.
Questions about supplying Zimbabwe
Something else? Email [email protected].
Do you export medicines to Zimbabwe?
Yes. Progene Pharma manufactures generic medicines in a WHO-GMP certified facility and supplies them to importers, wholesalers, hospital suppliers and tender suppliers in Zimbabwe.
Can you help us register products with MCAZ?
Yes. Progene Pharma prepares the documents MCAZ 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 Zimbabwean company submits the application, and we answer MCAZ's questions with you.
Do I need a local company to register and import?
Yes. MCAZ registers a medicine through a company registered in Zimbabwe, usually the importer or distributor, which must also hold the licences to import and wholesale medicines. Check the current requirements with MCAZ.
How long does MCAZ 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 MCAZ's questions helps. Many importers register a few products first and add more as orders grow.
Which documents does MCAZ ask for?
The usual set is a CTD dossier, a COPP, a GMP certificate, stability data, a letter of authorisation, product samples and artwork. MCAZ updates its requirements from time to time, so confirm the current list with MCAZ or your regulatory agent. We tell you what we can provide with your quotation.
What is ZAZIBONA?
It is a collaboration between medicines regulators in Southern Africa, including Zimbabwe, that share the assessment of a dossier so a product can be reviewed once for several countries. Tell us the countries you plan to sell in and we will confirm how to prepare the file.
How is payment handled?
Foreign currency availability and the bank's requirements can affect payment, so we agree the payment terms with you before an order and tell you which documents your bank needs.
Can you supply NatPharm and NGO programmes?
Yes. Progene Pharma supplies tender and programme packs and the documents they usually ask for. Send us the requirements and we will confirm what we can provide.
What must the packs carry for Zimbabwe?
English text, the MCAZ registration number, batch number, manufacture and expiry dates, storage conditions and the other details MCAZ 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 Zimbabwe?
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 Zimbabwe?
Progene Pharma ships by sea from Nhava Sheva (JNPT) near Mumbai to Beira, Durban or Maputo, with onward road freight to Harare, or by air to Harare 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.
Related pages
Request a quote
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