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Steps (37) arrow_drop_up arrow_drop_down
Obtain medicine registration certificate  (6) expand_more expand_less
Obtain registration certificate of premises for wholesale medicine  (6) expand_more expand_less
Obtain medicines import permit  (5) expand_more expand_less
Pre-clearance documentation  (5) expand_more expand_less
Obtain TBS batch certificate  (6) expand_more expand_less
Clearance of medicine through Julius Nyerere International Airport (JNIA)  (9) expand_more expand_less

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Summary of the procedure

Institutions involved 8 expand_more expand_less

Tanzania Food and Drugs Authority (TFDA), Sub- Head Office (x 8)
Tanzania Food and Drugs Authority ( Eastern zone office) (x 5)
Swissport International Plc (x 5)
Clearing Agent
National Microfinance Bank (NMB)
TBS Import Inspection Office (x 5)
Tanzania Revenue Authority- Julius Nyerere Airport (x 3)

Results 6 expand_more expand_less

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

Required Documents expand_more expand_less

Application form for medicine registration (x 2)
Cover letter (x 2)
Certificate of incorporation (x 3)
Certificate of pharmaceutical product (x 2)
A table of contents (x 2)
Medicinal product dossier (x 2)
A site master file (x 2)
TFDA profoma invoice (x 2)
Stamped bank deposit slip
TFDA receipt (x 4)
Application form for premise registration
Application form for licence
Certified copy of academic certificate
Tax Identification Number certificate
Memorandum and articles of association
Commitment letter
Sketch location of the premise
Stamped bank deposit slip (x 3)
Customer registration form
Registration certificate of premise (x 2)
Proforma invoice
Bill of lading (x 3)
TFDA Invoice
Clearing agent's authorization letter for customs
Swissport invoice (x 3)
Importer identitification card (x 3)
Swissport payment receipt (x 2)
Provision permits for entry of imported goods
Self assessment document (TRA)
Commercial invoice (x 4)
Packing list (x 2)
TBS Debit advice (x 2)
Application letter for conditional release
Conditional release form
Clearing and forwarding agent identification card
Batch certificate inspection form
Application form for import batch certificate
TBS receipt
TBS testing report
Permission to import registered medicine product (x 2)
Batch certificate (x 2)
Control number (TRA)
Tanzania Single Administrative Document (TANSAD) (x 3)
Airway bill (x 3)
EAC certificate of origin
Permission to import medicine registered product with release stamp (x 2)
EAC certificate of origin with release stamp (x 2)
Batch certificate with release stamp (x 2)
Release order
Swissport gate pass

Estimated cost TZS  680,000 + USD  7,500.02

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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

USD 500
Registration of human and veterinary domestic medicine
USD 2,000
Registration of human, veterinary and biologicals medicine imported
USD 1,000
Registration of human and veterinary domestic medicine
USD 4,000
Registration of human, veterinary and biologicals medicine imported
TZS 300,000
Premise registration fee
TZS 50,000
Inspection fee
USD 0.02 -
2 % goods-value
of FOB value of a consignment
Equivalent to Tsh
USD 0 -
3 % goods-value
of CIF
TZS 30,000
Service fee
TZS 50,000
Application fee
TZS 100,000
Inspection fee
TZS 0 -
0.2 % goods-value
of C&F
Batch certificate 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

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): 55mn 5h. 20mn
Attention at counter: 4h. 50mn 5h. 35mn
Waiting time until next step (sum): 43 d 258 d

Laws 8 expand_more expand_less

East African Community Customs Management Act (Revised Edition 2009) East African Community Customs Management Act, 2004 (Revised Edition 2009)
  Sections 2, 33, 34, 38, 41, 147, 148, 235
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, 51, 52, 53, 73
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