List of steps
(Total number of steps: 13)
Obtain NEMC enviromental assessment certificate  (2)
Procure scoping report and TORs  (2)
Obtain scoping report and TORs approval  (2)
Actual EIA assessment  (1)
Obtain pharmaceuticals Manufacturing license  (6)

Preview & Print

Properties
 
Summary of the procedure
 

Where to go? (5)

You will have to go to the following agencies. The number indicates how many interactions are required with each entity.
National Environment Management Council (NEMC) (x 3)
2 5 6
National Environment Management Council (NEMC)
Customer's Site (x 2)
7 12
Customer's Site
Tanzania Food and Drugs Authority (TFDA) HQ (x 3)
8 10 13
Tanzania Food and Drugs Authority (TFDA) HQ
National Microfinance Bank (NMB)
9
National Microfinance Bank (NMB)
TFDA Eastern Zone Office
11
TFDA Eastern Zone Office

What you will get (2)

The objective of the procedure is to obtain those documents.
Premise registration certificate
13
Premise registration certificate
Business Licence
13
Business Licence

Required documents 

The documents with green band will be provided to you during the procedure.

Scoping report approval letter
6
Application for license form 0003 (TFDA)
8
Application for license form 0003 (TFDA)
Premise Registration form 0001 (TFDA)
8
Premise Registration form 0001 (TFDA)
Certificate of incentives
8
Certificate of incentives
Memorandum and Articles of Association
8
Memorandum and Articles of Association
Environmental Clearance Certificate
8
Environmental Clearance Certificate
Plant lay-out
8
Plant lay-out
TFDA proforma invoice
9
TFDA proforma invoice
NMB Bank slip
9
NMB Bank slip
NMB Bank Pay slip
10
NMB Bank Pay slip
TFDA Payment receipt
11
TFDA Payment receipt
TFDA payment receipt (x 2)
12 13
TFDA payment receipt

How much?

Cost of the procedure  TZS  850,000 + USD  3,250

Cost detail

Estimate your cost

TZS 700,000
Business permit fees for large pharmaceutical factory
TZS 150,000
Good Manufacturing Practice GMP Inspection fees per year
USD 3,000
Good Manufacturing Practice GMP inspection for facilities within the East African region
USD 250
GMP inspection fee for domestic/local pharmaceutical manufacturing plant

How long ?

The estimated total time is calculated by adding the time spent: 1) waiting in queue, 2) at the counter and 3) between steps.
  Min. Max.
Total time (sum): 10 d 20 d
of which:
Waiting time in queue (sum): 10mn 45mn
Attention at counter: 30mn 1h. 10mn
Waiting time until next step (sum): 10 d 20 d

Legal justification?

The regulations which justify the procedure and its content
THE TANZANIA FOOD, DRUGS AND COSMETICS ACT, 2003 THE TANZANIA FOOD, DRUGS AND COSMETICS ACT, 2003
  articles S. 22, S. 7
THE TANZANIA FOOD, DRUGS AND COSMETICS ACT, 2003 THE TANZANIA FOOD, DRUGS AND COSMETICS ACT, CAP 219, 2003
  articles 20, S. 18, S. 19
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