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Summary

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"Certification sheet" format

Steps (61)

Register with Pharmacy and Poisons Board (PPB) online service portal (3)

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

Register with KESWS (4)

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

Obtain Port Health Services release (6)

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

51 Pay for import health certificate

52 Submit clearance documents for verification

53 Verification of consignment

54 Obtain import health certificate

55 Obtain Port Health Services release

Obtain KEBS release (2)

56 Submit documents for verification

★ Pay destination inspection fees Optional

57 Verification of consignment

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

33

Pay for product registration
(last modified: 27/07/2021)

Costs

( see details )

Timeframe ( see details )

Free of charge

10 mn - 20 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?

PPB receipt for product registration

Common technical document (e-CTD) number letter

What documents do I need to bring?

1.

Pharmacy and Poisons Board (PPB) invoice (original)

Cost

KES

KES Add Name Here

Cost detail	Estimate your cost
USD 0 - USD 1,000 per product For product registration, for foreign products.	0

Payment methods: banker's cheque or company cheque

The cheque(s) should be drawn to: PHARMACY AND POISONS BOARD.

Time frame

Waiting time in queue: Min. 5mn - Max. 10mn

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

Legal justification

1.

Drug registration - Guidelines to submission of applications

Additional information

Once payment has been made, the system will automatically generate an e-CTD number.

Who certified this information ?

Dr. Dominic KARIUKI , Deputy Director, Product Evaluation and Reg, 12/07/2017

Report incorrect information Suggest a simplification

Recourse: Pharmacy and Poisons Board (PPB)

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

Office of the Head, Product Evaluation and Registration 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

Contact person

Dr. Ahmed I. Mohammed

Director, Product Evaluation and Registration
Tel: +254 733 884 411 / +254 720 608 811
Email: drug_reg@pharmacyboardkenya.org, medicaldevices@pharmacyboardkenya.org