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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)
TFDA profoma invoice
Stamped bank deposit slip
TFDA receipt (x 2)

Estimated cost  USD  1,500

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USD expand_more expand_less
  • USD Add Name Here
USD 500
Registration of human and veterinary domestic medicine
USD 1,000
Registration of human and veterinary domestic medicine

Total Duration 35 d - 241 d expand_more expand_less

  Min. Max.
Total time (sum): 35 d 241 d
of which:
Waiting time in queue (sum): 5mn 55mn
Attention at counter: 25mn 1h. 25mn
Waiting time until next step (sum): 35 d 240 d

Laws 3 expand_more expand_less

TFDA fee and charges regulation Tanzania Food, Drugs and Cosmetics (Fee and Charges) Regulations, 2015
  Sections 12, First Schedule
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 4, 5, 6
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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