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"Certification sheet" format

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"Certification sheet" format

Steps (38)

Obtain import registration certificate (2)

1 Apply for import registration certificate

2 Obtain import registration certificate

Obtain registration certificate of premises (6)

3 Submit application for premise registration

4 Obtain ZFDA invoice

5 Pay registration and inspection fees

6 Obtain ZFDA receipt and notification for inspection

7 Inspection of premise

8 Obtain registration documents

Obtain medicine registration certificate (5)

9 Obtain application documents

10 Pay fee

11 Obtain receipt

12 Submit application for medicine registration

13 Obtain medicine registration certificate

Obtain medicines import permit (4)

14 Register and apply for medicine import permit

15 Pay fees

16 Obtain receipt

17 Obtain medicine import permit

Obtain import permit (2)

18 Apply for import permit

19 Obtain import permit

Pre-clearance documentation (2)

20 Contract a clearing agent

21 Obtain cargo clearance documents

Obtain verified certificate of conformity (2)

22 Submit certificate of conformity for verification

23 Obtain verified certificate of conformity

Custom declaration (15)

24 Lodge custom documents (TRA)

25 Pay taxes

26 Obtain Tanzania Single Administrative Document (TANSAD)

27 Obtain delivery order

28 Obtain stamped delivery order from Maritime office

29 Obtain stamped delivery order from the Port Director

30 Obtain stamped delivery order from Director of operation

31 Obtain stamped delivery order from ZBS

32 Obtain stamped delivery order from TRA

33 Obtain invoice

34 Pay port charges

35 Obtain receipt

36 Obtain gate pass

37 Inspection of container

38 Obtain release order

Summary of the procedure

Institutions involved 13

Ministry of Trade and Industrial Development- head office (x 2)

1 18

Ministry of Trade and Industrial Development - Trade and marketing department (x 2)

2 19

Zanzibar Food and Drug Agency (ZFDA) (x 10)

3 4 6 7 8 9 12 13 16 17

The People's Bank of Zanzibar (PBZ) (x 6)

5 10 11 15 25 34

Zanzibar Food and Drugs Agency (Information Management System)

Clearing Agent

Shipping Agents (x 2)

21 27

Zanzibar Bureau of Standards (ZBS) (x 2)

22 23

Tanzania Custom Intergrated System (x 2)

24 26

Zanzibar Maritime Authority (ZMA)

Zanzibar Ports Corporation (head office) (x 4)

29 33 35 36

Zanzibar Ports Corporation (ZPC)

TANZANIA REVENUE AUTHORITY - ZANZIBAR PORTS CUSTOMS OFFICE (x 3)

32 37 38

Results 7

Registration certificate (export/import)

Registration certificate of premise (ZFDA)

Business permit of a premise (ZFDA)

ZFDA medicine registration certificate

Import permit (ZFDA)

Import permit (MT & I)

Verified certificate of conformity (ZBS)

Required Documents

Application letter as importer

Business licence (Zanzibar) (x 2)

1 3

Certificate of Incorporation-Zanzibar (x 2)

1 3

Memorandum and articles of association (MEMART)

Identity card - Zanzibar

Coloured passport size photo

Application form for registration as exporter/importer

Application form for registration of premise

Application form for business permit - ZFDA

Tax Identification Number certificate (x 3)

3 20 24

Payment invoice (ZFDA) (x 3)

5 10 15

Stamped bank deposit slip

Drugs inspection form checklist (ZFDA)

Plant layout sample

ZFDA receipt (x 3)

8 13 17

PBZ Bank Slip (x 2)

10 25

PBZ Stamped banksSlip (x 3)

11 16 35

Application letter for medicine registration (ZFDA)

Stamped medicine application form for registration (ZFDA)

Certificate of analysis of products

Profoma invoice

Bill of lading (x 2)

14 20

Packing list

Application letter for importation of medicine

Import permit (ZFDA) (x 2)

18 24

Clearing agent's authorization letter for customs (x 2)

20 24

Commercial invoice

Certificate of conformity (ZBS)

Bill of lading (x 5)

22 24 27 33 37

Packing list (x 4)

22 24 27 37

Commercial invoice (x 4)

22 24 33 37

Verified certificate of conformity (ZBS) (x 2)

24 37

Import permit (MT & I)

Import declaration form

Certificate of origin

Tax payment slip

Clearing agent authorization letter

Delivery order (x 2)

28 36

Profoma invoice (ZPC)

Tanzania Single Administrative Document (TANSAD)

Stamped delivery order (x 2)

37 38

Gate pass (Zanzibar) (x 2)

37 38

Consignment (container)

Estimated cost TZS 50,000 +USD 500

TZS

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 5,000 Application form fee
TZS 20,000 Premise registration fee
TZS 20,000 Premise inspection fee except manufacturing factory
TZS 5,000 Fee for application form
USD 500 Registration fee for imported products
- TZS 0 - 2 % Free On Board (FOB) Export permit fee	0
- TZS 0 - 0.3 % goods-value	0
- TZS 0 - 1 % Custom value Wharfage charges	0
- TZS 0 - 18 % Value added tax VAT	0
- TZS 0 - 0.6 % Custom value Custom Processing Charge	0
- TZS 0 - 18 % Value Added Tax	0
- USD 0 - USD 90 per container Fee for a full container 20ft	0
- USD 0 - USD 50 per container Fee for a full container load 20ft	0

Total Duration 184d - 372d

	Min.	Max.
Total time (sum):	184d	372d
of which:
Waiting time in queue (sum):	35mn	3h. 50mn
Attention at counter:	1h. 30mn	4h. 50mn
Waiting time until next step (sum):	183d	370d

Laws 13

Compendium of Medicines Evaluation and Registration (ZFDA)

East African Community Customs Management Act, 2004 (Revised Edition 2017)

East African Community Customs Management Act, 2004 (Revised Edition 2019)
Sections 2, 38, 41, 73, 74, 75, 76, 82, 123, 125, 126, 127, 145, 146, 147, 148, 181, 187, 188, 189