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Summary

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Properties

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"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

28

Pay for certificate of good manufacturing practices
(last modified: 27/07/2021)

Where to go?
Recourse

Costs

( see details )

Timeframe ( see details )

USD 4,000

10 mn - 40 mn

Where to go?

Entity in charge

Pharmacy and Poisons Board (PPB)

P.O. Box 00506-27663, Lenana Road Opp. Department of Defence, Nairobi
Tel: +254 203 562 107 / +254 720 608 811
Email: enquiries@pharmacyboardkenya.org, info@pharmacyboardkenya.org
Website: http://pharmacyboardkenya.org/
Directions:

Unit in charge

Accounts Counter (Pharmacy and Poisons Board)

Mon:	09:00 - 13:00, 14:00 - 16:00
Tue:	09:00 - 13:00, 14:00 - 16:00
Wed:	09:00 - 13:00, 14:00 - 16:00
Thu:	09:00 - 13:00, 14:00 - 16:00
Fri:	09:00 - 13:00, 14:00 - 16:00

Contact person

Accountant (Pharmacy and Poisons Board)

Accountant
Tel: +254 720 608 811
Email: accounts@pharmacyboardkenya.org

What do I get?

Pharmacy and Poisons Board (PPB) receipt

What are the requirements?

Pharmacy and Poisons Board (PPB) invoice (original)

Cost USD 4,000

KES

KES Add Name Here

USD 4,000

For a certificate of good manufacturing practices.

Payment methods: cheque or bank transfer on requisition for foreign companies

PPB will provide the account details for payments via bank transfer upon request by the applicant(s), who will have to submit the proof of payment (bank deposit slip) at PPB offices.

Time frame

Waiting time in queue: Min. 5mn - Max. 30mn

Attention at counter: Min. 5mn - Max. 10mn

Legal justification

Pharmacy and Poisons Act Rules
Section 19

Report incorrect information Suggest a simplification

Recourse: Pharmacy and Poisons Board (PPB)

Entity in charge

Pharmacy and Poisons Board (PPB)

Unit in charge

Inspection, Surveillance and Enforcement Department (PPB)

Mon:	08:00 - 13:00, 14:00 - 17:00
Tue:	08:00 - 13:00, 14:00 - 17:00
Wed:	08:00 - 13:00, 14:00 - 17:00
Thu:	08:00 - 13:00, 14:00 - 17:00
Fri:	08:00 - 13:00, 14:00 - 17:00
Sat:	closed
Sun:	closed