NTA Level 6 • Semester 1 • PST06103

Registration and Regulation of Pharmaceutical Manufacturing in Tanzania

Pharmaceutical Production • Source Session/Topic 2

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Session 2: Registration and Regulation of Pharmaceutical Manufacturing in

Tanzania

Total Session Time: 120 minutes

Pre-requisites

• None

Learning Tasks

By the end of this session students are expected to be able to:

• Explain the registration of businesses in Tanzania

• Explain the role of Tanzania investment centre in promoting

pharmaceutical manufacturing

• Outline the licensing of businesses in Tanzania

• Explain the role of TFDA in establishing and regulating manufacturing of

pharmaceuticals

• Explain the role of TRA pharmaceutical manufacturing

Resources Needed:

• Flip charts, marker pens, and masking tape

• Black/white board and chalk/whiteboard markers

• LCD projector and computer

SESSION OVERVIEW

SESSION CONTENTS

STEP 1: Presentation of Session Title and Learning Tasks (5 minutes)

READ or ASK students to read the learning tasks and clarify

ASK students if they have any questions before continuing

STEP 2: Company Registration (25 minutes)

|Activity: Buzzing (5 minutes) |

| |

|ASK students to pair up and buzz on the following question for 2 |

|minutes |

| |

|How are companies or businesses registered in Tanzania? |

| |

|ALLOW few pairs to respond and let other pairs to add on points not |

|mentioned |

| |

|WRITE their response on the flip chart/board |

| |

|CLARIFY and SUMMARIZE by using the content below |

• In order to do business in Tanzania, a business entity in form of a sole

proprietorship, partnership or limited liability company needs to be

formed

• The business entity in form of sole proprietorship, partnership must be

registered with the Business Registration and Licensing Agency (BRELA)

which is under the Ministry of Industries and Trade

• The first step in registration of the business name is to obtain name

clearance from BRELA

• Generally, the following documents are required for in the process of

forming a company;

o Name of the company

o The address of the company in Tanzania

o Names, residential addresses and nationalities of the first

subscribers and directors (at least two)

o Memorandum of Association (stating in details the objects of the

company) and Articles of Association (stating in details the

management structure and processes)

▪ At least two copies of the documents each documents are required

o Filling a prescribed form to declare that a company has complied with

the requirements of the Tanzania company law, and

o Payment of filing fees, registration fee and the stamp duty

• A certificate of registration (for sole proprietorship and partnership)

or Incorporation (for a limited company) is issued after completion of

the registration process

• After registering the name of the company, Tax Identification Number

(TIN) should be obtained from Tanzania Revenue Authority (TRA)

STEP 3: Investment Approval (20 minutes)

• In order to make investment incentives from Tanzania Investment Centre

(TIC), the following documents are required;

o Project’s business plan/feasibility study

▪ Intended project should aim at foreign exchange generation and

savings, import substitution, creation of employment opportunities,

linkage benefits, transfer of technology, expansion of production

of goods and services etc.

▪ The feasibility study should contain clear statement of the

project objective, information regarding the investor, details of

investments costs (foreign and local expected capital expenditure),

how the proposed investment will be financed, specific sources(s)

of finance for the project, terms and condition of loans if

applicable, sources of technology if applicable, project financial

and economic analysis, market study, project capacity, production

process if applicable, environmental impact assessment, expected

employment generation, proposed implementation schedule, etc.

o Filled application form from issued by TIC

o In case of expansion/rehabilitation, a copy of audited account for the

past three years

o A copy of the company’s Memorandum and Articles of Association

o Certified copy of the Certificate of company incorporation

o A brief profile of the investor(s)

o Evidence of sufficient financial capital available to implement the

project

o Evidence of land ownership for the location of the project

o Project implementation schedule, and

o An overall covering letter to which all the above are attached

• The role of TIC in promoting investment in pharmaceutical industry are;

o Aftercare service

▪ This is a core functional unit in investment promotion and

facilitation whose role to facilitate both the successful start-up

and continuing development of the investment with a view towards

maximizing its contribution to the local economic development

▪ Aftercare unit offers assistance in ensuring that the investment

project is implemented free of unnecessary obstacles

o Access to various services related to permits, licenses and approvals

in the TIC One Stop Facilitation Centre

▪ Companies Registration (BRELA) for registration of company

▪ Tanzania Revenue Authority (TRA) for issues related to taxes

▪ National Environment Council (NEMC) for environmental impact

assessment

▪ Tanzania Foods and Drugs Authority for licensing in manufacturing

of pharmaceutical products

▪ Tanzania Electric Supply Company (TANESCO) for electric power

supply

▪ IOccupational Health and Safety Authority (OSHA) for issues

related to occupational health

▪ Facilitates the process of obtaining work permit, resident

permit, business license and land acquisition

o Issuance of Certificate of incentives to investors

▪ Incentives offered;

▪ The recognition of private property and protection against any

non-commercial risks. Tanzania is an active member of the World

Bank Foreign Investment Insurance wing, MIGA (Multilateral

Investment Guarantees Agency)

▪ Zero percent (0%) Import Duty on Project Capital Goods,

Computers and Computer Accessories, Raw Materials and Replacement

Parts for Agriculture, Animal Husbandry and Fishing, Human and

Livestock Pharmaceuticals and Medicaments, Motor Vehicle in

Completely Knocked down (CKD) form and inputs for Manufacturing

Pharmaceutical Products

▪ Ten percent (10%) – Import Duty for Semi-processed/semi

finished goods)

▪ Introduction of pay and refund scheme for excise duty paid on

fuel purchased by eligible companies

▪ The Income Tax Laws allows 50% Capital allowances in the first

year of use for Plant and Machinery used in manufacturing

processes and fixed in a factory

▪ VAT Deferment granted on project capital Goods such as Plant &

Machinery. However the persons have to keep proper VAT records

and file returns, has no Tax outstanding and VAT payable in

respect of each unit of the Capital goods is twenty million

Shillings or above

STEP 4: Business Licensing (20 minutes)

• Type and number of required licenses differ from one sector to another

depending on the degree of regulation in the sector involved

• For investment in pharmaceutical industry, the following specific

licenses are required;

o Industrial license issued by the Ministry of Industries and Trade

▪ Issued after application is made to the Industrial Licensing

Board

▪ The requirements for obtaining an industrial license are;

▪ Filling an application

▪ Submission of copies of memorandum and Articles of

Association, Certificate of incorporation on the company

▪ Submission of a Business plan

▪ Submission of a Lease agreement/Title Deed

o Special license/permits issued by Tanzania Food and Drugs Authority

(TFDA)

• General Business License

o Apart from fulfilling the sector specific requirement (in this case

pharmaceutical sector), all businesses must obtain a general business

license issued under the Business Licensing Act, 1972. To obtain this

general license, the applicant must submit the following documents;

▪ Copy of certificate of incorporation or certificate of compliance

(in case of a company) or certificate of registration or extract

(in case of partnership or sole traders)

▪ Memorandum and Articles of Association showing among other things

the objectives of the company allowing it to the business which the

license is being applied for

▪ Proof of Tanzania citizenship e.g. photocopy of passport, birth

certificate, or in case of non-citizen –a resident permit Class A

(showing the holder to be the investor in the company/business)

▪ In case of the shareholders of the company are non-residents, a

Power of Attorney to a citizen/resident must be submitted

▪ Proof by the applicant having a suitable business premises for

the business applied

▪ Proof that can be submitted includes title deed, tenancy

agreements, receipt of rent or property tax payment

▪ Tax Identification Number (TIN) issued by Tanzania Revenue

Authority (TRA)

STEP 5: Medicine Manufacturing Licence (30 minutes)

|Activity: Small Group Discussion (15 minutes) |

| |

|DIVIDE students into small manageable groups |

| |

|ASK students to discuss on the following question |

|What is the role of TFDA in establishing and regulation of |

|pharmaceutical manufacturing in Tanzania? |

| |

|ALLOW students to discuss for 15 minutes |

| |

|ALLOW few groups to present and the rest to add points not mentioned |

| |

|CLARIFY and SUMMARIZE by using the contents below |

• Medicines are one of the groups of items regulated by the Tanzania Food,

Drugs and Cosmetics Act, 2003. The others are food and cosmetic products

• The Act is enforced by the Tanzania Food and Drugs Authority (TFDA)

• TFDA issues license for manufacturing processes for all products

regulated under the Act, including medicines

• Any investor in pharmaceutical manufacturing must obtain a manufacturing

license from TFDA after fulfilling the following conditions;

o The premises in which the applicant proposes to manufacture the

respective products have been inspected and registered by TFDA for

that purpose

o Provide evidence that the substances he intends to use are of a

quality satisfactory of the standards prescribed by TFDA in respect of

the product he proposes to manufacture

o Provide evidence of having sufficient financial resources such as

would enable him, in relation to the manufacture of products regulated

under the TFDA Act, to maintain the standards of quality prescribed by

or under the act

o The applicant must have not, within twelve months immediately

preceding present application, been convicted of an offence under this

Act or any other written law relating to quality standards of products

regulated by TFDA Act

o The applicant must have adequate expertise or skill or has personnel

qualified to execute the business for which he is seeking to be

licensed

o The applicant must have adequate facilities such as would enable him

to maintain the standards of quality prescribed in relation to the

manufacture of the products for which he is seeking to be licensed

STEP 6: Taxes in Pharmaceutical Manufacturing (10 minutes)

• Tanzania Revenue Authority (TRA) is responsible for all issues related to

taxes

• In the process of the pharmaceutical company (like any other company), a

Tax Identification Number (TIN) should be obtained from the TRA

o In application for a TIN, the following are required;

▪ Filling of a TIN application form

▪ Submission of Business registration or Certificate of

Incorporation and Memorandum and Articles of Association

▪ Fulfilment of immigration procedures (for non-citizens)

• All taxes and duties payable and exemptions (whenever

applicable) are communicated to the investors by TRA

STEP 6: Key Points (5 minutes)

• In order to do business in Tanzania, a business entity in form of a sole

proprietorship, partnership or limited liability company needs to be

formed

• The business entity in form of sole proprietorship, partnership must be

registered with the Business Registration and Licensing Agency (BRELA)

which is under the Ministry of Industries and Trade

• Tanzania Investment Centre (TIC) has a core functional of promoting

investment and facilitating both the successful start-up and continuing

development of the investment with a view towards maximizing its

contribution to the local economic development

STEP 7: Evaluation (5 minutes)

• What is the role of BRELA in establishing a pharmaceutical manufacturing

company?

• How is TIC involved in investment in manufacturing of pharmaceuticals in

the country?

• What is the role of TFDA in pharmaceutical manufacturing?

References

URT, The Tanzania Investment Act, 1997

URT, The Tanzania Business Licensing Act, 1972

URT, National Industries (Registration and Licensing) Act, 2002

URT, Business Names (Registration) Act, 2002

ONLINE TAXPAYER REGISTRATION USER GUIDE. (n.d.). Retrieved from

https://gateway.tra.go.tz/OnlineTin/USER_GUIDE.pdf

Administration – tfda.go.tz. (n.d.). Retrieved from

https://www.tfda.go.tz/sites/default/files/tfdaact_1.pdf

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