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Steps (6) arrow_drop_up arrow_drop_down
Obtain medicine registration certificate  (6) 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), Sub- Head Office (x 5)
Bank

Results 1 expand_more expand_less

Certificate of registration of medicine

Required Documents expand_more expand_less

Application form for medicine registration (x 2)
Cover letter (x 2)
Certificate of incorporation (x 2)
Certificate of pharmaceutical product (x 2)
A table of contents (x 2)
Medicinal product dossier (x 2)
A site master file (x 2)
TMDA profoma invoice
Stamped bank deposit slip
TMDA receipt (x 2)

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 121d - 151d  expand_more expand_less

  Min. Max.
Total time (sum): 121d 151d
of which:
Waiting time in queue (sum): 15mn 1h.
Attention at counter: 30mn 1h. 25mn
Waiting time until next step (sum): 120d 150d

Laws 3 expand_more expand_less

TFDA fee and charges regulation Tanzania Food, Drugs and Cosmetics (Fees and Charges) Regulations, 2015 First schedule
  Section  12
The Tanzania Food, Drugs and Cosmetics (Registration of Medicinal products) Regulations, 2015 The Tanzania Food, Drugs and Cosmetics (Registration of Medicinal products) Regulations, 2015
  Sections 5, 6, 12, 13
THE TANZANIA FOOD, DRUGS AND COSMETICS ACT, CAP 219, 2003 The Tanzania Food, Drugs and Cosmetics Act, 2003
  Sections 51, 52, 53
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