InfoTradeKenya

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Properties

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"Certification sheet" format

Preview & Print

Properties

Print the full procedure

Print selected step:

Include recourse information

"Certification sheet" format

Steps (68)

1 Apply for PPB registration

2 Register with PPB online service portal

3 Obtain user credentials

Obtain wholesale dealer's licence and certificate of premise registration (6)

4 Apply for wholesale dealer's licence and premise registration

5 Pay for wholesale dealer's licence and premise registration

6 Obtain notification of approval

7 Obtain notification of inspection

8 Inspection of premises

9 Obtain registration documents

10 Submit request for company registration

11 Obtain registration notification

12 User registration

13 Obtain user credentials

Obtain drug sample permit (3)

14 Obtain unique consignment reference

15 Apply for drug sample permit

16 Obtain drug sample permit

Drug sample clearance (6)

17 Notification of consignment

18 Submit drug sample importation permit

19 Obtain payment notification

20 Pay prescribed fees

21 Submit payment receipt

22 Delivery of drug sample

Obtain certificate of analysis (4)

23 Request for sample analysis

24 Obtain quotation

25 Submit samples and pay for analysis

26 Obtain certificate of analysis

Obtain certificate of good manufacturing practices (5)

27 Apply for certificate of good manufacturing practices

28 Pay for certificate of good manufacturing practices

29 Submit documents for verification

30 Obtain application approval

31 Obtain certificate of good manufacturing practices

Obtain product registration certificate (4)

32 Apply for product registration

33 Pay for product registration

34 Submit product samples

35 Obtain product registration certificate

Obtain pharmaceutical import permit (5)

36 Apply for import permit

37 Payment authorisation

38 Pay for import permit

39 Submit documents for permit approval

40 Obtain import permit

Obtain import declaration form (2)

41 Apply for import declaration form

42 Obtain import declaration form

Pre-clearance documentation (1)

43 Contract a clearing agent

Obtain delivery order (4)

44 Notification of arrival of cargo

45 Submit bill of lading

46 Pay shipping line charges

47 Obtain delivery order

Obtain KEBS consignment document (1)

48 Obtain KEBS consignment document

Obtain passed clearance entry (3)

49 Lodge a customs entry

50 Pay taxes and merchant shipping (MS) levy

51 Obtain passed entry

Obtain PPB release (2)

52 Submit clearance documents for verification

53 Verification of consignment

Obtain import health certificate (4)

54 Apply for import health certificate and generate e-slip

55 Pay for import health certificate

★ Pay for import health certificate (For bank payments) Optional

56 Verification of consignment

57 Obtain import health certificate

Obtain Port Health release (1)

58 Obtain Port Health release

Obtain KEBS release (1)

59 Submit documents for verification

★ Pay destination inspection fees (for consignments that arrive without a CoC) Optional

★ Submit bank deposit slip Optional

★ Physical verification of consignment Optional

Obtain KRA release (3)

60 Submit clearance documents for verification

61 Verification of consignment

62 Obtain KRA final online release

Obtain KPA release (4)

63 Create pick up order

64 Pay KPA charges

65 Obtain position slip

66 Loading of the container on to truck

Obtain gate pass (2)

67 Physical release of consignment

68 Obtain gate pass

Summary of the procedure

Institutions/Systems involved 17

Pharmacy and Poisons Board (PPB) Online Services Portal (x 2)

1 4

Pharmacy and Poisons Board (PPB) Trade Portal (x 4)

2 9 32 35

Pharmacy and Poisons Board (PPB) (x 15)

3 5 6 7 8 27 28 29 30 31 33 34 37 38 39

Kenya Trade Network Agency (KenTrade) (x 3)

10 11 13

Trade Facilitation Platform (TFP) (x 7)

12 36 40 54 55 57 58

Kenya Electronic Single Window System (KESWS) (x 5)

14 15 16 48 59

Courier Service Provider (x 5)

17 18 19 21 22

Bank (x 4)

20 46 50 64

Mission for Essential Drugs Supplies (MEDS) (x 4)

23 24 25 26

Integrated Customs Management System (iCMS) (x 2)

41 42

Clearing Agent

Shipping Agent (x 3)

44 45 47

Pharmacy and Poisons Board (PPB) (Kilindini) (x 2)

52 53

Port Health Services Kenya (PHS) (Kilindini)

Kenya Revenue Authority (KRA) Kipevu Container Terminal (CT 2) (Kipevu) (x 3)

60 62 67

Kenya Revenue Authority (KRA), Containerised Cargo and Container Freight Station (CFS)

Kenya Ports Authority (KPA) (x 3)

65 66 68

Results 12

User credentials

Wholesale dealer's licence

Certificate for registration of premises

Annual practice licence for pharmacists

User credentials

Drug sample

Certificate of analysis

Certificate of good manufacturing practices

Product registration certificate

Commercial medicines import permit

Import declaration form (IDF)

Gate pass

Required Documents

Identity card (x 2)

2 47

Company PIN certificate

Individual PIN certficate

List of shareholders (Form CR-12)

Certificate of incorporation (x 2)

2 4

Form CR 2

Academic qualification

Request for company registration

Company PIN

Wholesale dealer's licence (x 5)

15 36 37 39 52

Invoice

Drug sample permit

Bank deposit slip (x 2)

21 47

Sample analysis request

Laboratory client registration form

Test request form

Certificate of analysis

Site master file (x 2)

27 29

Pharmacy and Poisons Board (PPB) invoice (x 4)

28 29 33 34

Pharmacy and Poisons Board (PPB) receipt (x 3)

29 34 39

Certificate of good manufacturing practices authorization letter

Application for registration of a drug - Form 1

Certificate of analysis (x 3)

32 54 58

Certificate of good manufacturing practices

Certificate of pharmaceutical product

Product registration certificate (x 4)

36 37 39 52

Invoice (x 10)

36 37 39 41 46 48 54 58 59 60

Submitted commercial medicines import permit

Authorization for payment for commercial medicines import permit (x 2)

38 39

Permit (x 4)

41 54 58 60

Bill of lading (x 5)

43 45 52 59 60

Proforma invoice (x 2)

43 52

Letter of indemnity

Valid port pass (x 2)

47 65

Import declaration form (IDF) (x 4)

48 52 59 60

Packing list (x 5)

48 52 54 59 60

Commercial invoice

Customs entry in under control status (x 3)

52 58 60

Commercial medicines import permit (x 2)

52 52

Medical device import permit

Medical device listing

Form C - Import authorization and certificate of official approval of import

Certificate of analysis

Passed clearance entry stamped stop by PPB

Certificate of quality

Certificate of conformity (COC) (x 2)

54 59

Material safety data sheet

Health certificate (x 2)

54 58

Phytosanitary certificate (x 2)

54 54

Plant import permit

Fumigation certificate (x 4)

54 54 58 58

GMO free certificate (x 2)

54 58

Import health certificate

Packing list

Laboratory analysis report

Test report

KRA receipt

Clearing agent authorization letter

Marine cover insurance

Bankers cheque

KPA invoice

Pick up order

Position slip

Passed clearance entry stamped goods released by KEBS

Position slip endorsed by KPA

Quadruplicate entry

Position slip stamped by KRA

Estimated cost KES 91,750 +USD 4,070

KES

KES 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
KES 30,000 For wholesale dealer licence.
KES 10,000 For certificate of registration of premises.
KES 5,000 For annual practice licence for a pharmacist.
KES 250 For airline concession fees.
KES 800 For KEBS inspection. For goods worth KES 50 000 and below.
KES 1,200 For KEBS inspection. For goods worth KES 50 001 - KES 100 000.
KES 1,500 For KEBS inspection. For goods worth KES 100,001 - KES 500,000.
- KES 0 - 1.5 % goods-value For KEBS inspection. For goods worth KES 500,000 and above.	0
- KES 0 - KES 25 per kilogram per day	0
- KES 0 - KES 35 per kilogram per day	0
- KES 0 - KES 55 per kilogram per day	0
KES 42,000 For sample analysis - estimate.
USD 4,000 For a certificate of good manufacturing practices.
- USD 0 - USD 1,000 per product For product registration, for foreign products.	0
- KES 0 - 0.75 % Free on board (FOB)	0
USD 70 Documentation fees - estimate.
- KES 0 - 16 % Cost, Insurance & Freight (CIF) or customs value For Value Added Tax.	0
- KES 0 - 2 % Cost, Insurance & Freight (CIF) or customs value For import declaration form.	0
- KES 0 - 1.5 % Cost, Insurance & Freight (CIF) or customs value For railway development levy.	0
- USD 0 - USD 1.75 per weight in tons For a 20 feet container to a maximum of 5 tons per TEU. For merchant shipping levy.	0
- USD 0 - USD 2 per weight in tons For a 40 feet container to a maximum of 6 tons per TEU. For merchant shipping levy.	0
KES 1,000 For issuance of import health certificate.
- USD 0 - USD 105 per container For shore handlingcharges.	0
- USD 0 - USD 70 per container For wharfage charges.	0
- USD 0 - USD 160 per container For shore handling charges.	0
- USD 0 - USD 105 per container For wharfage charges.	0

Total Duration 184d - 957d

	Min.	Max.
Total time (sum):	184d	957d
of which:
Waiting time in queue (sum):	2h. 5mn	7h. 55mn
Attention at counter:	5h. 25mn	3d
Waiting time until next step (sum):	183d	953d