print

Preview & Print

Properties

Preview & Print

Properties

Steps (45) 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
Pre-clearance documentation  (3) expand_more expand_less
Obtain medicines import permit  (5) 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

arrow_drop_up arrow_drop_down
Summary of the procedure

Institutions involved 10 expand_more expand_less

Tanzania Medicines and Medical Devices Authority (TMDA), Sub- Head Office (x 8)
Tanzania Medicines and Medical Devices Authority (TMDA) ( Eastern zone office) (x 5)
Clearing Agent
Shipping Agents (x 3)
TBS Import Inspection Office (x 2)
CONTAINER FREIGHT STATION
Tanzania Revenue Authority-Headquarters (x 2)
Tanzania Ports Authority-Dar es salaam (x 4)
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
Verified certificate of conformity
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)
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 (x 4)
Memorandum and articles of association (x 2)
Commitment letter
Sketch location of the premise
Stamped bank deposit slip (x 7)
Clearing agent's authorization letter for customs (x 4)
Commercial invoice (x 5)
Packing list (x 4)
Certificate of origin (import)
Customer registration form
Registration certificate of premise (x 2)
Proforma invoice
TFDA Invoice
Certificate of conformity
Self assessment document (TRA)
Certificate of conformity with TBS received stamp
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
Verified 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 with reference number
Driver details
TPA receipt (x 3)
Driving licence
Gate in ticket (x 2)
Gate pass A
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  2,139.02

expand_more expand_less

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 1,000
Registration of human and veterinary domestic medicine
TZS 300,000
Premise registration fee
TZS 50,000
Inspection fee
USD 0 -
3 % Cost, Insurance and Freight or Custom value
Clearing agent fees-estimate
USD 0.02 -
2 % goods-value
of FOB value of a consignment
Equivalent to Tsh
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 46 d - 275 d expand_more expand_less

  Min. Max.
Total time (sum): 46 d 275 d
of which:
Waiting time in queue (sum): 1h. 15mn 6h. 50mn
Attention at counter: 2h. 25mn 6h. 55mn
Waiting time until next step (sum): 46 d 274 d

Laws 15 expand_more expand_less

Tarrif book (TPA) "Tariff book of port dues and charges (TPA)"
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, 145, 146, 147, 148, 181, 188, 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
  Section  24 ,  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 (Fee and Charges) Regulations, 2015
  Sections 4, 12, First Schedule, First schedule no.104 ,  Article Schedule (162)
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 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
The Tanzania Harbours Regulations, 1991 The Tanzania Harbours Regulations, 1991
  Sections 210, 214, 222, 287, 304
The value added tax Act, 2014 The Value Added Tax Act, 2014
  Section  3
Used motorvehcle PVoC procedures Used motor vehicle PVoC procedures
  Section  4
Powered by eRegulations ©, a content management system developed by UNCTAD's Business Facilitation Program and licensed under Creative Commons License