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Properties

Steps (31) arrow_drop_up arrow_drop_down
Obtain registration certificate of premises for wholesale medicine  (6) expand_more expand_less
Obtain medicine registration certificate  (6) expand_more expand_less
Obtain medicines import permit  (4) expand_more expand_less
Pre-clearance documentation  (4) expand_more expand_less
Clearance of medicine through Julius Nyerere International Airport (JNIA)  (11) expand_more expand_less

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Summary of the procedure

Institutions involved 9 expand_more expand_less

Tanzania Medicines and Medical Devices Authority (TMDA) ( Eastern zone office) (x 5)
Tanzania Medicines and Medical Devices Authority (TMDA), Sub- Head Office (x 7)
Customer online self service portal (TMDA)
Clearing Agent
Tanzania Custom Intergrated System (x 3)
Tanzania Revenue Authority- Julius Nyerere Airport (x 3)
National Microfinance Bank (NMB)

Results 5 expand_more expand_less

Registration certificate of premise
Business permit of a premise (TFDA)
Certificate of registration of medicine
Permission to import registered medicine product
Release order

Required Documents expand_more expand_less

Application form for premise registration
Application form for licence
Certified copy of academic certificate
Tax Identification Number certificate (x 3)
Memorandum and articles of association
Certificate of incorporation (x 3)
Commitment letter
Sketch location of the premise
TMDA profoma invoice (x 2)
Stamped bank deposit slip (x 2)
TMDA receipt (x 4)
Application form for medicine registration (x 2)
Cover letter (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)
Customer registration form
Registration certificate of premise
Proforma invoice
Bill of lading
TFDA Invoice
Payment advice
Clearing agent's authorization letter for customs (x 2)
Commercial invoice
Packing list
Permission to import registered medicine product (x 2)
Certificate of origin (x 2)
Commercial invoice (x 3)
Packing list (x 2)
Control number (TRA)
Tanzania Single Administrative Document (TANSAD)
Airway bill (x 3)
Permission to import registered medicine with release stamp (x 2)
Certificate of origin with release stamp
Importer identitification card
Handling shed invoice
Release order
Handling shed invoice
Gate pass
Representatives
Clearing agent authorization letter
Clearing agent's authorization letter for customs

Estimated cost TZS  350,000 +USD  6,000

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TZS expand_more expand_less
  • TZS Add Name Here
This is an estimate based on a series of assumptions which you can modify to calculate your own costs:

Cost detail

Estimate your cost

TZS 300,000
Premise registration fee
TZS 50,000
Inspection fee
USD 2,000
Registration fee of human, veterinary and biological medicine
USD 4,000
Fast track registration fee of human, veterinary and biological medicine
USD 0 -
2 % Free On Board (FOB)
Medicine import permit fee
USD 0 -
3 % goods-value
of CIF
TZS 0 -
1.6 % goods-value
For domestic imported products
TZS 0 -
18 % Custom value
Value Added Tax VAT
TZS 0 -
1.5 % Custom value
Railway development levy
TZS 0 -
0.6 % Custom value
Custom Processing Unit CPU

Total Duration 129d - 169d  expand_more expand_less

  Min. Max.
Total time (sum): 129d 169d
of which:
Waiting time in queue (sum): 45mn 4h. 25mn
Attention at counter: 2h. 5h.
Waiting time until next step (sum): 128d 168d

Laws 8 expand_more expand_less

East African Community Customs Management Act, 2004 (Revised Edition 2017) East African Community Customs Management Act, 2004 (Revised Edition 2019)
  Sections 2, 33, 34, 38, 39, 40, 41, 125, 126, 127, 145, 146, 147, 148, 181, 188, 235
East African Community Customs Management Regulations (2010) East African Community Customs Management Regulations, 2010
  Sections 33, 34, 39, 40, 44, 45, 46, 50, 53, 131, 235
Guideline for importation and exportation of medicines products Guideline for importation and exportation of medicines products
  Section  1
Swissport approved terminal charges Swissport approved terminal charges
TFDA fee and charges regulation Tanzania Food, Drugs and Cosmetics (Fees and Charges) Regulations, 2015 First schedule no.104
  Sections 4, 12 ,  Article Schedule (162)
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 5 (h), 18, 20, 21, 51, 52, 53, 73
The value added tax Act, 2014 The Value Added Tax Act, 2014
  Section  3
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