Importing medicines into Tanzania
Regulator, legal routes, documents, approval times and shipping lanes for medicines supplied from India to Tanzania.
At a glance
- Regulator
- TMDA
- Main route
- TMDA special permit for an unregistered product
- Courier transit from India
- 3 to 6 days
- Air cargo transit from India
- 4 to 9 days
Short answer
Medicines in Tanzania Mainland are regulated by the Tanzania Medicines and Medical Devices Authority (TMDA). An unregistered medicine enters on a TMDA special permit under section 57(1) of the Act, requested by a hospital, healthcare provider, government institution, importing wholesaler or, for personal use, the patient with a prescription. Supply to a patient without a TMDA permit is not allowed.
Research summary, confirm with the regulator or a local agent
This guide was researched from official and published sources. A regulatory specialist has not confirmed it yet, so check current requirements before you rely on it.
Content updated November 13, 2026
Key facts
- Regulator
- Tanzania Medicines and Medical Devices Authority (TMDA)
- Main route
- TMDA special permit for an unregistered product
- Who applies
- Hospital, healthcare provider, government institution or TMDA-registered importing wholesaler
- Import permit or approval
- Needed before goods ship
- Supply addressed to patients
- Not a legal route. Supply goes to a licensed consignee
- Typical approval time
- TMDA publishes service targets of one working day for standard import permits and seven working days for special permits. Queries restart the clock, and TMDA advises applying at least six weeks before the consignment is loaded.
- Courier transit from India
- 3 to 6 days
- Air cargo transit from India
- 4 to 9 days
- Common Incoterms
- CIP, CPT, DAP, FCA
- Local currency
- TZS
- Languages
- Swahili, English
Legal routes and who applies
Routes for a medicine that is not registered in Tanzania. The local party named under each route files the application, not the exporter.
- Route 1Within 7 working days (published by TMDA)
TMDA special permit for an unregistered product
TMDA issues special permits under section 57(1) of the Tanzania Medicines and Medical Devices Act to allow import of unregistered products. The applicant uploads a covering letter with the reasons and a certificate of analysis for each product, plus a supporting letter and local purchase order when importing for a health facility. TMDA expects that no registered equivalent is available, or that a registered equivalent has not been imported for at least six months, and that the product comes from a TMDA-approved GMP facility.
Who applies: Hospital, healthcare provider, government institution or TMDA-registered importing wholesaler
- Route 2Within 1 working day (published by TMDA)
TMDA import permit for a registered product
Registered medicines are imported on a standard permit lodged on TMDA's online trader portal. The permit covers one shipment, or two partial shipments, and is valid for six months from the TMDA invoice date, with one extension of up to three months possible.
Who applies: Importer whose premises are registered with TMDA
- Route 3Within 7 working days (published by TMDA)
Special permit for personal use
TMDA lists the general public among those who can apply for a special permit for personal use. The application needs a prescription from a registered medical practitioner and a letter giving the reasons for the import if TMDA asks for one. Travellers entering Tanzania Mainland may carry up to 21 days of their own medicine without this permit.
Who applies: The patient or a representative, with a prescription from a registered practitioner
- Route 4Within 7 working days for special requests (published by TMDA)
Import permit for investigational products
Investigational and comparator products for a trial approved in Tanzania Mainland are imported on a TMDA permit. The application must include the clinical trial approval letter issued by TMDA.
Who applies: Clinical trial sponsor or principal investigator
Document checklist
Documents a buyer in Tanzania usually needs. The exact list depends on the route and the product.
- TMDA special permit or import permit printed from the online portal
- Covering letter stating the reasons for importing the unregistered medicine
- Supporting letter and local purchase order from the health facility
- Prescription from a registered practitioner for personal use imports
- TMDA premises registration of the importer
- Proforma invoice and commercial invoice
- Certificate of analysis for each batch
- Evidence that the manufacturing site is TMDA GMP approved
- Air waybill
- Clinical trial approval letter for investigational products
The documents a country, buyer type and product usually need, ready to print.
Build a checklist for your requestThe regulator
The Tanzania Medicines and Medical Devices Authority (TMDA) regulates medicines in Tanzania Mainland under the Tanzania Medicines and Medical Devices Act (Cap 219). Section 73 of the Act gives TMDA its mandate over imports and exports. TMDA's import and export control page sets out the main rules:
- Importers must register their premises with TMDA before applying for permits.
- Recognised importer categories are government and non-government institutions, importing wholesalers, manufacturers, clinical trial sponsors and investigators, and recipients of donations.
- Applications are lodged on TMDA's online trader portal, at least six weeks before loading.
- Narcotic drugs are imported only by the Medical Stores Department. Other facilities need a TMDA permit before buying them from that department.
TMDA also publishes a list of registered importing wholesalers for 2025 to 2026. The rules on this page cover Tanzania Mainland. Zanzibar has its own regulator, so confirm the route for consignments going there.
Legal routes for unregistered medicines
Special permit under section 57(1)
TMDA issues a special permit to allow import of an unregistered product. Hospitals, healthcare providers, government institutions, clinical trial staff and members of the public importing for personal use can apply. TMDA's import guidelines (fourth edition, January 2021) list the conditions for an unregistered medicine:
- A covering letter stating the reasons and a certificate of analysis for each product.
- For a health facility, a supporting letter and local purchase order from that facility.
- No registered therapeutic equivalent, or a registered equivalent that TMDA confirms has not been imported for at least six months.
- Manufacture in a TMDA-approved GMP facility.
Special requests are processed within seven working days, against one day for standard permits.
Personal use, trials and donations
A personal-use permit needs a prescription from a registered practitioner and, if TMDA asks, a letter giving the reasons. Visitors and returning residents may carry up to 21 days of their own medicine. Investigational products are imported by the sponsor or principal investigator with TMDA's clinical trial approval letter. Donations need a donation certificate and must follow the Ministry of Health donation guidelines.
Documents a buyer usually needs
- TMDA special permit or import permit, printed from the portal
- TMDA premises registration of the importer
- Covering letter with reasons, and the facility's supporting letter and local purchase order
- Prescription from a registered practitioner, for personal-use imports
- Proforma invoice and commercial invoice, with the original proforma travelling with the goods
- Certificate of analysis for each batch
- Evidence of TMDA GMP approval for the manufacturing site
- Air waybill
Timeline: a worked example
A private hospital in Dar es Salaam needs a biologic for a rare disease. The product has no registered equivalent in Tanzania.
| Step | Who acts | Typical time |
|---|---|---|
| Supporting letter and local purchase order | Hospital pharmacy and treating physician | 1 to 3 days |
| Proforma invoice, certificate of analysis and GMP evidence | Exporter in India | 2 to 5 days |
| Special permit application and TMDA review | Hospital or importing wholesaler | Within 7 working days (published) |
| Export documents and dispatch from India | Exporter and forwarder | 2 to 7 days |
| Nonstop flight Mumbai to Dar es Salaam | Carrier | 1 to 2 days |
| TMDA inspection and customs release | TMDA inspector, customs and clearing agent | 1 to 3 days |
Total: roughly 2 to 5 weeks if the manufacturing site already has TMDA GMP approval. If it does not, expect a much longer lead time. These are planning estimates built on TMDA's published targets.
Shipping lanes from India
Air Tanzania operates a daily Dar es Salaam to Mumbai service, and IndiGo has announced daily Mumbai to Dar es Salaam flights from 20 November 2026, subject to approvals. Medicines enter through authorised ports such as Julius Nyerere International Airport, Kilimanjaro International Airport and the Dar es Salaam sea port. Express courier service is usually 3 to 6 days door to door. Air cargo is usually 4 to 9 days including TMDA inspection and customs.
CIP, CPT and DAP to Dar es Salaam are common, and FCA suits importers that use their own forwarder.
Practical tips for buyers
- Check TMDA GMP approval for the manufacturing site first. Without it, a special permit for an unregistered product is unlikely.
- Remaining shelf life must be at least 60 percent for products with a shelf life over 24 months, and at least 80 percent for shorter-dated products.
- Each consignment must travel with the permit, the original proforma invoice, the commercial invoice, the air waybill and a certificate of analysis for each batch.
- TMDA may sample antimalarials, antiretrovirals, anti-tuberculosis medicines and antibiotics at the port for quality testing.
- Duty on HS 3004 medicines is 0 percent under the East African Community tariff according to World Bank WITS data. The VAT Act (Cap 148) exempts essential human medicines approved by the responsible Minister. Other imports pay the standard 18 percent VAT.
Shipping from India at a glance
Typical transit times and terms on the lanes from Indian airports to Tanzania.
Courier, door to door
3 to 6 days
Air cargo with clearance
4 to 9 days
Usual Incoterms
Cold chain on this lane
Nonstop flights between Mumbai and Dar es Salaam keep air time short, and TMDA inspects every consignment at the port of entry before release. Validated passive shippers of 72 to 96 hours usually cover door to door, provided the permit is printed and the paperwork is ready before the goods land.
Check a shipper against this laneTransit times are typical estimates from India, not carrier commitments.
Questions about importing into Tanzania
Can a medicine that is not registered in Tanzania be imported?
Yes, on a TMDA special permit issued under section 57(1) of the Tanzania Medicines and Medical Devices Act. The applicant explains the reasons, provides a certificate of analysis, and shows that no registered equivalent is available or that one has not been imported for at least six months.
Who can apply for a TMDA special permit?
TMDA lists hospitals, healthcare providers, government institutions, clinical trial staff and members of the public importing for personal use. Importing wholesalers can also apply for unregistered products. Applications are made on TMDA's online trader portal.
How long does TMDA take to issue a special permit?
TMDA's published target is seven working days for special permits and one working day for standard import permits. Queries restart the review, and TMDA advises applying at least six weeks before the goods are loaded.
Can a patient in Tanzania import a medicine for personal use?
TMDA allows members of the public to apply for a special permit for personal use with a prescription from a registered practitioner. Most patients still go through their hospital or an importing wholesaler, which handles the permit and clearance. Travellers may carry up to 21 days of their own medicine.
Does the manufacturing site need TMDA approval?
For a special permit covering an unregistered medicine, TMDA's guidelines expect the product to come from a TMDA-approved GMP facility. Check this before quoting, since it can decide whether the route is available at all.
What taxes apply to imported medicines in Tanzania?
World Bank WITS data shows 0 percent East African Community tariff duty on HS 3004 medicines. The VAT Act exempts essential human medicines approved by the responsible Minister, and other imports pay 18 percent VAT. Confirm the treatment of the specific product with a customs agent.
Do TMDA rules apply to Zanzibar?
TMDA's import guidelines cover Tanzania Mainland. Zanzibar has its own regulator, so a consignment for Zanzibar should be checked with the Zanzibar authorities before it ships.
Sources
Official sources first, then published secondary sources. Each was read when this guide was researched.
- 1.TMDA, Import and export control
- 2.TMDA, Guidelines for importation and exportation of pharmaceutical products and raw materials (fourth edition, January 2021)
- 3.TMDA, List of registered importing wholesalers for 2025 to 2026
- 4.Ministry of Health Tanzania, Tanzania Medicines and Medical Devices Act (Cap 219)
- 5.Tax Revenue Appeals Board, The Value Added Tax Act (Cap 148 R.E. 2023)
- 6.World Bank WITS, Tanzania MFN tariff on HS 300490 (TRAINS 2023)
- 7.US International Trade Administration, Tanzania import tariffs
- 8.The Citizen, Air Tanzania makes Mumbai route daily
- 9.Aviation and Defence Universe, IndiGo adds Dar es Salaam to its network
This page explains how regulatory routes work. It is not legal or medical advice. Confirm current requirements with the regulator or a local agent before goods ship.
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