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Steps (37) 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  (5) expand_more expand_less
Pre-clearance documentation  (4) expand_more expand_less
Obtain TBS batch certificate  (5) 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 8)
Clearing Agent
TBS Services Online Application System
TBS Import Inspection Office (x 3)
Tanzania Revenue Authority- Julius Nyerere Airport (x 2)
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
Batch certificate

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 2)
Memorandum and articles of association
Certificate of incorporation (x 3)
Commitment letter
Sketch location of the premise
TFDA profoma invoice (x 2)
Stamped bank deposit slip (x 4)
TFDA 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 (x 2)
Proforma invoice
Bill of lading (x 3)
TFDA Invoice
Payment advice
Clearing agent's authorization letter for customs
Commercial invoice (x 6)
Packing list (x 4)
Provision permits for entry of imported goods
Self assessment document (TRA)
TBS Debit advice
Application letter for conditional release
Conditional release form
Importer identitification card (x 3)
Clearing and forwarding agent identification card
Batch certificate inspection form
Application form for import batch certificate
TBS receipt
TBS testing report
Animal health certificate
Clearance certificate for imported milk and milk products
Milk and milk products import permit
Permission to import food
Certificate of conformity
Certificate of origin
Control number (TRA)
Tanzania Single Administrative Document (TANSAD)
Airway bill (x 3)
Fertilizer import permit
Airway bill with release stamp
Fertilizer import permit with TFRA release stamp
Permission to import medicine registered product with release stamp
Phytosanitary certificate with release stamp
Handling shed invoice1 (x 2)
Handling shed invoice
Release order
Swissport gate pass
Representatives
Authorization letter

Estimated cost TZS  630,000 + USD  1,500.02

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USD expand_more expand_less
  • USD 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 500
Registration of human and veterinary domestic medicine
USD 1,000
Registration of human and veterinary domestic medicine
USD 0.02 -
2 % goods-value
of FOB value of a consignment
Equivalent to Tsh
USD 0 -
3 % goods-value
of CIF
TZS 100,000
Inspection fee
TZS 0 -
0.2 % goods-value
of C&F
Batch certification fee
TZS 30,000
Service fee
TZS 150,000
Physical verification fee
TZS 0 -
1.6 % goods-value
For domestic imported products
TZS 0 -
1.25 % goods-value
For transit imported product
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 43 d - 259 d expand_more expand_less

  Min. Max.
Total time (sum): 43 d 259 d
of which:
Waiting time in queue (sum): 50mn 4h. 55mn
Attention at counter: 4h. 50mn 5h. 10mn
Waiting time until next step (sum): 43 d 258 d

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, 41, 147, 148, 235 ,  articles 74, 187, Se 73
East African Community Customs Management Regulations (2010) East African Community Customs Management Regulations, 2010
  Sections 39, 40, 53
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 (Fee and Charges) Regulations, 2015
  Sections 4, 12, First Schedule, First schedule no.104 ,  Article Schedule (162)
Batch certification regulation The Standards (Compulsory Batch Certification of Imports) Regulations, 2009
  Sections 3 (1), 4 (1-2), 8 (1), 10, 12 c, d
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, 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
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