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Preview & Print

Properties

Steps (8) arrow_drop_up arrow_drop_down
Apply for medicine registration  (3) expand_more expand_less
Obtain of Tanzania GMP compliance certificate  (4) expand_more expand_less
Obtain medicine registration certificate  (1) expand_more expand_less

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Summary of the procedure

Institutions involved 3 expand_more expand_less

RIMS Customer Self Service Portal (x 2)
Bank (x 2)
Tanzania Medicines and Medical Devices Authority (TMDA), Sub- Head Office (x 4)

Results 1 expand_more expand_less

Certificate of registration of medicine

Required Documents expand_more expand_less

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

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 5mn - 2h.   expand_more expand_less

  Min. Max.
Total time (sum): 5mn 2h.
of which:
Waiting time in queue (sum): 0mn 1h.
Attention at counter: 5mn 1h.

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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