1. Export
  2. Commodities
  3. Medicine
  4. Initial registration and licences
  5. Registration of medicine
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Properties

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 3 expand_more expand_less

RIMS Customer Self Service Portal (x 2)
1 4
Bank
2
Tanzania Medicines and Medical Devices Authority (TMDA), Sub- Head Office
3

Results 1 expand_more expand_less

Certificate of registration of medicine
4

Required Documents expand_more expand_less

Application form for medicine registration
1
Cover letter
1
Certificate of incorporation
1
Medicinal product dossier
1
Certificate of pharmaceutical product
1
Certificate of compliance to GMP
1
TMDA profoma invoice
2

Estimated cost USD  1,500

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TZS expand_more expand_less
  • TZS Add Name Here
USD 500
Registration fee of human and veterinary domestic medicine
USD 1,000
Fast track registration fee of human and veterinary domestic medicine

Total Duration 15mn - 1h. 5mn  expand_more expand_less

  Min. Max.
Total time (sum): 15mn 1h. 5mn
of which:
Waiting time in queue (sum): 5mn 30mn
Attention at counter: 10mn 35mn

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 52, 53
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