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Steps (41) 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  (4) expand_more expand_less
Obtain verified certificate of conformity  (2) expand_more expand_less
Custom declaration  (3) expand_more expand_less
Verification of consignment  (3) expand_more expand_less
Obtain TRA release order  (2) expand_more expand_less
Obtain delivery order  (3) expand_more expand_less
Port clearance  (7) expand_more expand_less
Obtain fish and fishery products export licence copy  (5) expand_more expand_less

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Summary of the procedure

Institutions involved 12 expand_more expand_less

Tanzania Medicines and Medical Devices Authority (TMDA), Sub- Head Office (x 7)
Tanzania Medicines and Medical Devices Authority (TMDA) ( Eastern zone office) (x 5)
Customer online self service portal (TMDA)
TBS Services Online Application System (x 2)
CONTAINER FREIGHT STATION
Tanzania Revenue Authority-Headquarters (x 2)
Shipping Agents (x 2)
TPA Intergated Electronic Payment System Portal
Tanzania Ports Authority-Dar es salaam (x 4)
Cargo System
Ministry of Livestock and Fisheries (x 4)

Results 8 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
Verification notification
Release order
Delivery order
Fish and fisheries export licence

Required Documents expand_more expand_less

Application form for medicine registration (x 2)
Cover letter (x 2)
Certificate of incorporation (x 4)
Certificate of pharmaceutical product (x 2)
A table of contents (x 2)
Medicinal product dossier (x 2)
A site master file (x 2)
TMDA profoma invoice (x 2)
Stamped bank deposit slip
TMDA receipt (x 4)
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 (x 2)
Commitment letter
Sketch location of the premise
Stamped bank deposit slip (x 6)
Customer registration form
Registration certificate of premise
Proforma invoice
TFDA Invoice
Self assessment document (TRA)
Product registration certificate
Certificate of conformity
Commercial invoice (x 4)
Packing list (x 4)
Clearing agent's authorization letter for customs (x 2)
Verified certificate of conformity (x 2)
Permission to import registered medicine product (x 2)
EAC certificate of origin (x 2)
Assessment document (TRA)
Tanzania Single Administrative Document (TANSAD)
Invoice (TICTS)
EAC certificate of origin with release stamp
Certificate of conformity with TBS release stamp
Verified certificate of roadworthiness (x 2)
Inspection vehicle sheet (x 2)
Motor vehicle.
Shipping line invoice
Importer identitification card
Clearing and forwarding agent identification card
Release order (x 4)
Delivery order (x 4)
TPA payment note
Driver details
TPA receipt (x 3)
Driving licence
Gate in ticket (x 2)
Gate pass 'A' Manifest Cargo
Application form for export licence for fish and fishery products (form 3C)
Application letter (fisheries)
Business licence
Tax clearance certificate
Introduction letter from local government authority
Extract from register
Collection licence from local government authority
Birth certificate
Coloured passport size photo
Standard sanitary operational procedure (SSOP)
Good manufacturing practice (GMP) Certificate
HASAP Manual
Certificate of Environmental Impact Assessment
Application form for permit to construct/renovate/ adapt a fish establishment
Invoice (uvuvi)
Government receipt

Estimated cost TZS  1,000,000 +USD  6,639

expand_more expand_less

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

USD 2,000
Registration fee of human, veterinary and biological medicine
USD 4,000
Fast track registration fee of human, veterinary and biological medicine
TZS 300,000
Premise registration fee
TZS 50,000
Inspection fee
USD 0 -
2 % Free On Board (FOB)
Medicine import permit fee
TZS 0 -
1.6 % Custom value
For imported products
TZS 0 -
1.5 % Custom value
Railway Development Levy RDL
TZS 0 -
0.6 % Free On Board (FOB)
Custom Processing Charge CPC
TZS 0 -
18 % Custom value
Value added tax VAT
USD 240
Handling fee for a 20ft container
USD 50
Documentation fee-estimate
USD 45
Delivery order fee-estimate
USD 18
Shipping service fee-estimate
USD 6
Corridor levy
USD 20
Handling fee for 20ft container
USD 160
Handling fee for a 20ft container
USD 100
Handling fee for a 20ft container
TZS 400,000
Auditing fee
TZS 100,000
Approval certificate
TZS 150,000
Quality manuals

Total Duration 132d - 186d  expand_more expand_less

  Min. Max.
Total time (sum): 132d 186d
of which:
Waiting time in queue (sum): 1h. 30mn 6h. 10mn
Attention at counter: 2h. 15mn 6h. 10mn
Waiting time until next step (sum): 131d 184d

Laws 14 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, 125, 126, 127, 235
East African Community Customs Management Regulations (2010) East African Community Customs Management Regulations, 2010
  Sections 39, 40, 53, 131
General goods PVoC procedures General goods PVoC procedures
  Article 4
Guideline for importation and exportation of medicines products Guideline for importation and exportation of medicines products
  Section  1
Ocean freight tariff Ocean freight tariff
  Article Table 9
TFDA fee and charges regulation Tanzania Food, Drugs and Cosmetics (Fees and Charges) Regulations, 2015 First schedule
  Sections 4, 12 ,  Article Schedule (162)
Tarrif book (TPA) Tariff book of port dues and charges (TPA)
Fisheries act The Fisheries Act, 2003
  Section  21 (d)
The Fisheries Regulations, 2005 The Fisheries Regulations, 2009
  Sections 13 (10), 13 (2)(a), 29, 72
Port service charges Act The Port Service Charges Act
  Section  8
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 Tanzania Harbours Regulations, 1991 The Tanzania Harbours Regulations, 1991
  Sections 210, 214, 222, 287
The value added tax Act, 2014 The Value Added Tax Act, 2014
  Section  3
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