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"Certification sheet" format

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"Certification sheet" format

Steps (73)

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

Obtain training certificate (6)

10 Apply for training

11 Obtain training response

12 Pay for training

13 Submit payment receipt

14 Obtain training status notification

15 Training

16 Submit request for company registration

17 Obtain registration notification

18 User registration

19 Obtain user credentials

Obtain drug sample permit (1)

20 Obtain unique consignment reference

★ Apply for drug sample permit Optional

★ Obtain drug sample permit Optional

Drug sample clearance (6)

21 Notification of consignment

22 Submit drug sample importation permit

23 Obtain payment notification

24 Pay prescribed fees

25 Submit payment receipt

26 Delivery of drug sample

Obtain certificate of analysis (4)

27 Request for sample analysis

28 Obtain quotation

29 Submit samples and pay for analysis

30 Obtain certificate of analysis

Obtain certificate of good manufacturing practices (5)

31 Apply for certificate of good manufacturing practices

32 Pay for certificate of good manufacturing practices

33 Submit documents for verification

34 Obtain application approval

35 Obtain certificate of good manufacturing practices

Obtain product registration certificate (4)

36 Apply for product registration

37 Pay for product registration

38 Submit product samples

39 Obtain product registration certificate

Obtain import declaration form (2)

40 Apply for import declaration form

41 Obtain import declaration form

Obtain commercial medicines import permit (7)

42 Obtain unique consignment reference

43 Apply for import authorization and certificate of official approval of import

44 Obtain import authorization and certificate of official approval of import

45 Apply for import permit

46 Obtain payment authorization

47 Pay for import permit

48 Obtain import permit

Pre clearance documentation (4)

49 Contract a clearing agent

50 Obtain KEBS consignment document

51 Notification of arrival of consignment

52 Obtain cargo clearance documents

Obtain passed clearance entry (3)

53 Lodge a customs entry

54 Pay tax and concession fee

55 Obtain passed entry

Obtain KRA release (10)

56 Submit clearance documents for verification

57 Collect allocation for verification

58 Physical verification of consingment

59 Collect clearance documents approved by head verification officer

60 Obtain customs verification officer's approval

61 Obtain handling shed invoice

62 Pay for handling shed charges

63 Obtain delivery notification

64 Obtain customs border control approval

65 Verification of consignment and clearance documents

Obtain KEBS release (4)

66 Submit certificate of conformity for validation

67 Submit documents for KEBS clearance

68 KEBS verification of consignment

69 Obtain KEBS clearance

Obtain port health release (3)

70 Submit request for Port Health clearance

71 Port Health verification of consignment

72 Obtain port health clearance

Obtain KRA final release (1)

73 Physical release of consignment

Summary of the procedure

Institutions involved 11

Pharmacy and Poisons Board (PPB) (x 12)

3 6 7 8 32 33 34 35 37 38 46 47

Kenya Trade Network Agency (KenTrade) (x 7)

11 13 14 15 16 17 19

Bank (x 3)

12 24 54

Courier Service Provider (x 5)

21 22 23 25 26

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

27 28 29 30

Clearing Agent

Handling Shed (x 6)

51 61 62 63 65 73

Kenya Revenue Authority (KRA) (Handling Shed) (x 6)

56 57 58 59 60 64

Kenya Bureau of Standards (KEBS) (JKIA)

Kenya Bureau of Standards (KEBS) (Handling Shed) (x 3)

67 68 69

Port Health Services Kenya (Handling Shed) (x 3)

70 71 72

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

Import declaration form (IDF)

Commercial medicines import permit

Release order stamped by KEBS

Required Documents

Identity card (x 2)

2 15

Company PIN certificate (x 2)

2 49

Individual PIN certficate

List of shareholders (Form CR-12)

Certificate of incorporation (x 3)

2 4 49

Memorandum of association - Form CR 2

Academic qualification

Bank deposit slip

Training status notification

KenTrade receipt

Request for company registration

Company PIN

Drug sample permit

Bank deposit slip (x 3)

25 63 65

Sample analysis request

Laboratory client registration form

Test request form

Certificate of analysis

Site master file (x 2)

31 33

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

32 33 37 38

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

33 38

Certificate of good manufacturing practices authorization letter

Application for registration of a drug - Form 1

Certificate of analysis

Certificate of good manufacturing practices

Certificate of pharmaceutical product

Commercial medicines import permit

Invoice (x 8)

40 45 53 56 64 65 67 70

Application letter

Certificate of analysis

Proforma invoice

Wholesale dealer's licence (x 2)

43 45

Product registration certificate (x 2)

43 45

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

Authorization for payment for commercial medicines import permit

Import declaration form (IDF) (x 6)

50 56 64 65 67 70

Commercial medicines import permit (x 2)

53 56

Air waybill (x 7)

53 61 63 64 65 67 73

Certificate of conformity (x 4)

53 56 66 67

KRA e-slip

Passed clearance entry

KRA receipt

Release order

Release order stamped by HVO

Release order stamped by VO (x 3)

61 63 64

Handling shed invoice

Packing list (x 2)

64 70

Release order stamped by customs border control

Delivery notification

KEBS consignment document (x 2)

66 67

Release order stamped by handling shed

Stamped plant import permit

Clearance entry

Valid E-slip (x 2)

70 72

Phytosanitary certificate

Import health certificate

Release order stamped by KEBS (x 2)

72 73

Estimated cost KES 101,000 + USD 4,000.33

USD

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
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 10,000 For training
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 % Freight on board (FOB)	0
- KES 0 - 1 % goods-value Clearing agent fees - estimate.	0
KES 250 For airline concession fee.
- KES 0 - 1.5 % Cost, Insurance & Freight (CIF) or customs value Railway development levy.	0
- KES 0 - 2 % Cost, Insurance & Freight (CIF) or customs value For import duty.	0
USD 0.18 For handling charges.
USD 0.15 For storage charges per day.

Total Duration 185 d - 982 d

	Min.	Max.
Total time (sum):	185 d	982 d
of which:
Waiting time in queue (sum):	2h. 35mn	8h. 20mn
Attention at counter:	5h. 30mn	15h. 35mn
Waiting time until next step (sum):	185 d	981 d