1. MEDICINES AND DEVICES LICENCES FROM TMDA
  2. Registration of drugs and medical devices
  3. Obtain drugs/medicine registration certificate
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Steps (4) arrow_drop_up arrow_drop_down
Obtain medicine registration certificate  (4) expand_more expand_less

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Summary of the procedure

Institutions involved 2 expand_more expand_less

Tanzania Medicines and Medical Devices Authority (TMDA) HQ (x 3)
1 3 4
BANK
2

Results 1 expand_more expand_less

Medicine Registration Certificate
4

Required Documents expand_more expand_less

Medicine registration application form
1
Cover letter TMDA
1
Certificate of incorporation
1
Certificate of pharmaceutical product
1
Tables of content
1
Medical product dossier
1
Control number (TMDA) (x 2)
2 3
TMDA receipt
4

Estimated cost USD  6,000

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TZS expand_more expand_less
  • TZS Add Name Here
USD 2,000
Registration fee of human, veterinary and biological medicine
USD 4,000
Fast track registration fee of human, veterinary and biological medicine

Total Duration 4h. 20mn - 5h. 15mn  expand_more expand_less

  Min. Max.
Total time (sum): 4h. 20mn 5h. 15mn
of which:
Waiting time in queue (sum): 5mn 40mn
Attention at counter: 15mn 35mn
Waiting time until next step (sum): 4h. 4h.

Laws 3 expand_more expand_less

TFDA fees 2011 TFDA fees 2011
THE TANZANIA FOOD, DRUGS AND COSMETICS ACT, 2003 THE TANZANIA FOOD, DRUGS AND COSMETICS ACT, 2003
THE TANZANIA FOOD, DRUGS AND COSMETICS ACT, 2003 THE TANZANIA FOOD, DRUGS AND COSMETICS ACT, CAP 219, 2003
  Article S. 7
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