The opportunity is clear. The route isn’t.
Tanzania imports more than 90% of its medicines and around 80% of its medical devices. It’s a market of about 60 million people, part of both the East African Community and SADC, and a gateway to six landlocked neighbors.
For a manufacturer, the goal is simple: get your products on shelves, build steady sales, and use Tanzania as a base for regional growth.
The route is less simple. Before you sell a single pack, your products, your local partner and your warehouses all need approval.
The real worry
Most manufacturers aren’t worried about paperwork. They’re worried about committing time, stock and money, then finding out too late that something basic went wrong: a distributor controlling their registrations, a launch slipping by months, or profit stuck in Tanzania.
Here’s how the route works, and where to protect yourself.
1. Decide how you’ll enter
Route | Best for | Watch out for |
|---|---|---|
Local distributor | Testing the market at low cost | Less control over pricing, stock and registrations |
Your own subsidiary | Long-term control | Higher setup cost and full tax obligations |
Local partner | Local relationships and shared risk | Shared control. Needs strong governance |
Ask early: if this relationship ends in three years, what do we still own?
2. Get your products registered
Every medicine and medical device must be registered with the Tanzania Medicines and Medical Devices Authority (TMDA). For imported products, you’ll need:
- Marketing authorization for each product
- A good manufacturing practice inspection of your factory
- A local technical representative to act for you
TMDA holds WHO Maturity Level 3 status, among the most advanced in Africa. Expect a rigorous review, and registrations that carry weight.
Two things often missed: registration runs product by product, so start with your most important products. And registered products carry annual retention fees, so a large portfolio is an ongoing cost.
3. Choose your representative carefully
Your representative deals with the regulator for you and often influences who controls your registrations. Before signing:
- Check their capability, finances and track record.
- Check whether they represent competing products.
- Agree in writing who holds the registrations, and what happens if you part ways.
This is where many manufacturers lose control without realizing it.
4. Import, store and distribute properly
Each consignment needs an import permit, and warehouses must meet TMDA’s storage and distribution standards. For temperature-sensitive products, a cold chain failure costs you twice: once in lost stock, and again with the regulator.
5. Handle the local setup
- Your own company needs incorporation, tax registration and bank accounts.
- Importing and wholesale need a Class A business license from BRELA.
- Zanzibar is a separate market, with its own regulator and registration system. Mainland approval doesn’t cover it.
6. Plan how profit gets home
If you have a Tanzanian subsidiary:
- Corporate income tax is 30%.
- Dividends to a foreign parent attract 10% withholding tax.
- Royalties and service fees paid abroad attract 15%.
- Prices charged to your own subsidiary must be at arm’s length, and pharmaceutical pricing gets close attention from the tax authority.
A structure that works elsewhere can leave profit stuck, or invite a tax challenge, if it isn’t designed for Tanzania.
7. Know the government market before you bid
The Medical Stores Department buys medicines for public health facilities through tenders. But the rules favor local production: locally made products can get a price preference of up to 15%, and some tenders are limited to local suppliers.
For importers, that changes the math. For some manufacturers, the long-term answer is a local partner or local production, which the government actively supports with incentives.
Where manufacturers get stuck
- The distributor owned the registrations. When the relationship ended, moving them took months, and sales stopped.
- The launch came before approval. Stock arrived early, and some neared expiry before it could be sold.
- The tender plan ignored local preference. Expected government sales never came.
- The transfer price didn’t hold. The tax authority challenged it, with tax, interest and penalties.
What a well-planned entry looks like
- Your registrations are under your control.
- Your launch date is realistic, built around approvals.
- Your partner is accountable, with clear terms and reporting.
- Your structure gets profit home without surprises.
- Your head office can see what’s happening every month.
That’s the goal: growing sales in Tanzania, and a secure base from which to expand across East and Southern Africa.
How Glenrich helps
Entering a new market from abroad means making regulatory, commercial, tax and structural decisions at once, usually without a trusted team on the ground. Glenrich is that team. Our tax, investment advisory and risk specialists, working with our legal partners, guide you in three steps:
- Plan your route. Choose how to enter, model costs and returns, and set a realistic timeline.
- Structure it right. Design ownership, pricing and profit flows, and put strong contracts in place with your partners.
- Stay in control. Set up controls over stock, sales and cash, stay compliant, and get clear monthly reporting.
Planning to enter Tanzania? Let’s talk.
We work with international clients by video call, in English, around your time zone.
[Book a free introductory call] ·
Glenrich Consultants, Samora Tower, Dar es Salaam
Frequently asked questions (FAQ)
Can a foreign manufacturer register medicines in Tanzania?
Yes, through a local technical representative, with a good manufacturing practice inspection of the factory.
Do I need my own company to sell?
No. Many manufacturers start with a distributor. Your own company gives more control but costs more.
Are there ongoing costs after registration?
Yes. Registered products carry annual retention fees.
Can foreign manufacturers win government tenders?
Yes, but local products can get a price preference of up to 15%, and some tenders are for local suppliers only.
Does Mainland approval cover Zanzibar?
No. Zanzibar has its own regulator and process.
Further reading
- Distributor, Subsidiary or Partner: How to Enter Without Losing Control
- What It Really Costs to Enter Tanzania’s Pharmaceutical Market
- Company Registration in Tanzania
- Business Licenses in Tanzania
About Glenrich
Glenrich Consultants is a finance and risk partner for investors and businesses in Tanzania. Our team of accountants, tax consultants, investment advisors and risk specialists supports clients from market entry through to compliance, reporting and protection, across Tanzania Mainland and Zanzibar.