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Steps (30) arrow_drop_up arrow_drop_down
Obtain registration certificate of premises for wholesale medicine  (6) expand_more expand_less
Apply for medicine registration  (3) expand_more expand_less
Obtain medicines import permit  (3) expand_more expand_less
Obtain certificate of radioactivity analysis  (3) 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 12 expand_more expand_less

Tanzania Medicine and Medical Device Authority (x 5)
RIMS Customer Self Service Portal (x 2)
Tanzania Medicines and Medical Devices Authority (TMDA), Sub- Head Office
Customer online self service portal (TMDA)
Online RAC application (x 2)
Mobile E payment
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)
Permission to import registered medicine product
Radioactivity analysis certificate
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 2)
Commitment letter
Sketch location of the premise
TMDA profoma invoice. (x 2)
Stamped bank deposit slip
TMDA receipt (x 2)
Application form for medicine registration
Cover letter
Certificate of pharmaceutical product
A table of contents
Medicinal product dossier
A site master file
Registration certificate of premise
Proforma invoice
Bill of lading (x 2)
TFDA Invoice
Commercial invoice (x 2)
Control number (TAEC)
Payment advice
Clearing agent's authorization letter for customs (x 2)
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  4,385,000 +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
TZS 35,000
Radiation fee for consignment with FOB value inferior to TZS 10 milions
TZS 0 -
0.4 % Free On Board (FOB)
Radiation fee for consignment FOB valuesuperior to TZS 10 millions and inferiorto TZS 1 billion
TZS 4,000,000
Radiation fee for consignment with FOB value superior to 1 billion
USD 0 -
3 % goods-value
of CIF
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 Fee CPF

Total Duration 9d - 19d  expand_more expand_less

  Min. Max.
Total time (sum): 9d 19d
of which:
Waiting time in queue (sum): 25mn 3h. 55mn
Attention at counter: 1h. 30mn 4h. 15mn
Waiting time until next step (sum): 8d 18d

Laws 12 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
Tanzania Atomic Energy Commission Service Charter Tanzania Atomic Energy Commission Service Charter
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 Atomic energy (Fees and Charges) Regulations, 2011 The Atomic Energy (Fees and Charges) Regulations, 2011 Category A
  Article Fifth schedule
The Atomic Energy Act, 2003 The Atomic Energy Act, 2003
  Sections 30, 31
The Protection from Radiation Regulations The Protection from Radiation (control of radiation contaminated food stuff) Regulations, 1998
  Sections 4 (2), 4
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
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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