print

Preview & Print

Properties

Preview & Print

Properties

Steps (6) arrow_drop_up arrow_drop_down
Obtain medicine registration certificate  (6) expand_more expand_less

arrow_drop_up arrow_drop_down
Summary of the procedure

Institutions involved 2 expand_more expand_less

Tanzania Food and Drugs Authority (TFDA), 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)
A table of contents (x 2)
Medicinal product dossier (x 2)
Certificate of pharmaceutical product (x 2)
A site master file (x 2)
TFDA profoma invoice
Stamped bank deposit slip
TFDA receipt (x 2)

Estimated cost  USD  1,500

expand_more expand_less

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

Total Duration 60 d - 301 d expand_more expand_less

  Min. Max.
Total time (sum): 60 d 301 d
of which:
Waiting time in queue (sum): 20mn 55mn
Attention at counter: 35mn 1h. 30mn
Waiting time until next step (sum): 60 d 300 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, 12
THE TANZANIA FOOD, DRUGS AND COSMETICS ACT, CAP 219, 2003 The Tanzania Food, Drugs and Cosmetics Act, 2003
  Sections 52, 53
Powered by eRegulations ©, a content management system developed by UNCTAD's Business Facilitation Program and licensed under Creative Commons License