1. MEDICINES AND DEVICES LICENCES FROM TMDA
  2. Business permit for Drugs and medical devices
  3. Business permit for manufacturing
  4. Obtain pharmaceutical manufacturing business permit
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Steps (13) arrow_drop_up arrow_drop_down
Obtain NEMC enviromental assessment certificate  (2) expand_more expand_less
Procure scoping report and TORs  (2) expand_more expand_less
Obtain scoping report and TORs approval  (2) expand_more expand_less
Actual EIA assessment  (1) expand_more expand_less
Obtain pharmaceuticals Manufacturing license  (6) expand_more expand_less

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Summary of the procedure

Institutions involved 5 expand_more expand_less

National Environment Management Council (NEMC) (x 3)
2 5 6
Customer's premise/workplace (x 2)
7 12
Tanzania Medicines and Medical Devices Authority (TMDA) HQ (x 3)
8 10 13
National Microfinance Bank (NMB)
9
TMDA Eastern Zone Office
11

Results 2 expand_more expand_less

Premise registration certificate
13
Business Licence
13

Required Documents expand_more expand_less

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

Estimated cost TZS  850,000 +USD  3,250

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TZS expand_more expand_less
  • TZS Add Name Here
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

Total Duration 11d - 21d  expand_more expand_less

  Min. Max.
Total time (sum): 11d 21d
of which:
Waiting time in queue (sum): 10mn 45mn
Attention at counter: 30mn 1h. 10mn
Waiting time until next step (sum): 10d 20d

Laws 3 expand_more expand_less

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
The Tanzania Medicines and Medical Devices Act, Cap 219 of 2019
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