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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 (61)

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 passed clearance entry (3)

44 Lodge a customs entry

45 Pay taxes

46 Obtain passed entry

Enter the OSBP (1)

47 Submit clearance documents

Obtain PPB release (2)

48 Submit import documents for verification

49 Verification of consignment by PPB

Obtain KEBS release (2)

50 Submit documents for verification

★ Pay destination inspection fees Optional

51 Verification of consignment

Obtain Port Health Services release (6)

52 Apply for import health certificate and generate an e-slip

53 Pay for import health certificate

54 Submit clearance documents for verification

55 Verification of consignment

56 Obtain import health certificate

57 Obtain Port Health Services release

Obtain KRA release (3)

58 Submit clearance documents for verification

59 Verification of consignment

60 Obtain KRA release

Obtain KRA final release (1)

61 Physical release of consignment

Summary of the procedure

Institutions involved 13

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

Kenya Electronic Single Window System (KESWS) (x 10)

12 14 15 16 36 40 41 42 52 56

Courier Service Provider (x 5)

17 18 19 21 22

Bank (x 3)

20 45 53

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

23 24 25 26

Clearing Agent

Kenya Revenue Authority (KRA), One Stop Border Post (OSBP) (Namanga) (x 5)

47 58 59 60 61

Pharmacy and Poisons Board (PPB), One Stop Border Post (OSBP) (Namanga) (x 2)

48 49

Kenya Bureau of Standards (KEBS), One Stop Border Post (OSBP) (Namanga) (x 2)

50 51

Port Health Services Kenya, One Stop Border Post (OSBP) (Namanga) (x 3)

54 55 57

Results 13

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)

Passed clearance entry stamped released by KRA

Cargo manifest stamped released by KRA

Required Documents

Identity card

Company PIN certificate (x 2)

2 43

Individual PIN certficate

List of shareholders (Form CR-12)

Certificate of incorporation (x 3)

2 4 43

Form CR 2

Academic qualification

Request for company registration

Company PIN

Wholesale dealer's licence (x 4)

15 36 37 39

Invoice

Drug sample permit

Bank deposit slip

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 2)

32 52

Certificate of good manufacturing practices

Certificate of pharmaceutical product

Product registration certificate (x 3)

36 37 39

Invoice (x 10)

36 37 39 41 44 47 50 52 54 58

Submitted commercial medicines import permit

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

38 39

Permit (x 2)

41 58

Certificate of conformity (COC) (x 2)

44 50

KRA e-slip

Passed clearance entry (x 7)

47 48 49 50 54 57 58

Pharmaceutical import permit

Certificate of analysis

Proforma invoice

Packing list (x 3)

48 50 58

EAC certificate of origin form

Certificate of quality (x 2)

50 52

Import declaration form (IDF)

Phytosanitary certificate

Plant import permit

Food hygiene licence

Cargo manifest (C2)

Preferential certificate of origin

Passed clearance entry stamped by verification officer

Cargo manifest stamped by verification officer

Passed clearance entry stamped release by KRA

Cargo manifest stamped released by KRA

Estimated cost KES 91,750 +USD 4,000

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
- KES 0 - 1 % goods-value Clearing agent fees - estimate.	0
- KES 0 - 2 % Cost, Insurance & Freight (CIF) or customs value Railway development levy.	0
- KES 0 - 3.5 % Cost, Insurance & Freight (CIF) or customs value For import duty.	0
KES 1,000 For issuance of import health certificate.

Total Duration 184d - 957d

	Min.	Max.
Total time (sum):	184d	957d
of which:
Waiting time in queue (sum):	2h. 15mn	6h. 45mn
Attention at counter:	5h. 15mn	2d 1/2
Waiting time until next step (sum):	183d	954d