Why Invest in the Tanzanian Pharmaceutical Industry?

• Strategic geographical location (bordering 8 countries of which 6 are LLC, 3 major ports and 3 International Airports)
• Access to Tanzania (approx. 60 million), EAC (162 million) and SADC (450 million) market
• Peace and Sound political stability (multiparty, democracy, good governance, stable post –election and no civil wars)
• Bulk procurement by Government through MSD for SADC.
• Reputable & strong Regulatory Authority in Africa (WHO - ML3).
• Few narrow range of generic products registered.
• Limited number of sterile products manufacturing plants.
• Exemption of VAT for manufacturing equipment.
• Reduced application processing timelines
• No retention fees
• Abolishing importation fees for raw materials
• Assisted exportation for finished products.

How to Establish a manufacturing plant in Tanzania?

• Apply for registration of premises
• Start construction of the facility after approval from TMDA
• Apply for GMP inspection once the construction is completed
• Apply for marketing authorization of your products

Detailed information is available in the Procedure for Establishing a Pharmaceutical Plant in Tanzania.

Domestic Manufactures in Tanzania

Furthermore, two (2) facilities are under construction which are for human medicines. The list of the facilities that are under construction and products to be manufactured is as indicated below;

FAQs on Investing in Tanzania's Pharmaceutical Sector

Tanzania relies upon imports for more than 90% of medicines and 80% of medical devices. To ensure adequate and sustainable supply of the medical supplies in the country, Government is calling upon individuals/ companies to invest in this sector whereby they will be able to enjoy a wide range of incentives provided through TISEZA ranging from free land, duties and Tax exemptions.

Below are questions and answers which provides valuable information for investment in this sector: -

1. Which body regulates Medicines and Medical Devices in Tanzania?
   

   Tanzania Medicines and Medical Devices Authority (TMDA) is a semi-autonomous regulatory body under the Ministry of Health (MoH); which is responsible for protecting and promoting public health by ensuring safety, quality and effectiveness of medicines, medical devices and diagnostics.

2. How can I establish a pharmaceutical facility in Tanzania?

   Steps to follow when establishing a pharmaceutical manufacturing facility include:-
   Submit online application and upload copy of certificate of Registration from the Business Registration and Licensing Agency, copy of certificate of incentives from TISEZA, copy of memorandum and articles of association, approval from National Environment Management Council (NEMC) on suitability of the site for pharmaceutical manufacturing activities and schematic drawing of the proposed building.

3. Which incentives are provided to the domestic pharmaceutical manufacturers?
   1. Fiscal and non-fiscal incentives from TISEZA
   2. Technical support from TMDA
   3. Reduced/ waiver on products registration, inspection and retention fees
   4. Reduced timelines for product registration
   5. Preferential price and priority in the government tenders
4. Are there any special incentives provided for investors in the Pharmaceutical Sector?

   Yes, Pharmaceutical Sector is among 10 priority sectors that are provided special incentives including free investment land in the eight (8) Special Economic Zones located in Dar Es Salaam, Pwani, Dodoma and Shinyanga. Other Incentives include: -
   

   • Plant, Machinery and Raw materials VAT and duty free
   • 10 years Corporate Income Tax exemption
   • VAT and Import duty exemption on Capital Goods
   • VAT and import duty exemption on pre-fabricated Factory Buildings
   • VAT and import duty exemption on specialized utility vehicles specific to project
   • VAT exemption on services and utilities including electricity, water, port handling
   • Withholding tax exemption on services, dividends and interest on foreign bank loans
   • Building permits issued within 24 Hours
   • All licenses and permits to be procured hassle free at TISEZA Premier investors’ service centre
   • TISEZA market access support by connecting with buyers and distributors globally
   • TISEZA officers stationed at all Regional and main ports of exit to facilitate cross boarder transit processes

5. As a domestic manufacturer, will I have any advantage in government tenders?

   Yes, the public procurement Act No. 5, Cap 410 provides preferential price up to 15% for domestic manufacturers. Government through Medical Stores Department limit some tenders to domestic suppliers only.

   Procurement of medical products is done on tender basis guided by the Public Procurement Act, Cap 410 and its regulations. Section 57 - 62 of the act, provides preferential treatment for the products manufactured within the country during public procurement.

6. What are Tanzania’s import policies for medical materials and equipment?

   Imported medicines and medical devices should be registered by TMDA. Registration requires an applicant to have a local technical representative; submit application for marketing authorization and application for GMP inspection of the manufacturing site.

7. As a domestic pharmaceutical manufacturer, will I be allowed to export Medicines outside Tanzania?

   Yes, products manufactured in the country can be exported to other countries after obtaining necessary government permits

8. Are there any special economic zones for pharmaceutical manufacturing facilities?

   Yes, Tanzania Investment and Special Economic Zones Authority have seven Special Economic Zones (SEZ) located in Dar Es Salaam, Dodoma, Mbeya, Kigoma, Mtwara, Geita and Coastal Region. Within these zones, there are areas dedicated for construction of pharmaceutical manufacturing facilities.

9. How can I get information on the highly imported medicines and medical devices in Tanzania?

   Imports of medicines and medical devices are regulated by Tanzania Medicines and Medical devices Authority. Reports of imported medicines and medical devices along with their FoB values can be obtained from TMDA. Please click here for more information