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Summary

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"Certification sheet" format

Steps (54)

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 certificate of analysis (4)

4 Request for sample analysis

5 Obtain quotation

6 Submit samples and pay for analysis

7 Obtain certificate of analysis

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

8 Apply for wholesale dealer's licence and premise registration

9 Pay for wholesale dealer's licence and premise registration

10 Obtain notification of approval

11 Obtain notification of inspection

12 Inspection of premises

13 Obtain registration documents

Obtain certificate of good manufacturing practices (6)

14 Apply for certificate of good manufacturing practices

15 Pay for certificate of good manufacturing practices

16 Submit documents for verification

17 Obtain application approval

18 Inspection of premises

19 Obtain certificate of good manufacturing practices

Obtain product registration certificate (4)

20 Apply for product registration

21 Pay for product registration

22 Submit product samples

23 Obtain product registration certificate

Register with KESWS (4)

24 Submit request for company registration

25 Obtain registration notification

26 User registration

27 Obtain user credentials

Obtain registration letter (3)

28 Submit application for registration

29 Verification of the origin of goods

30 Obtain registration letter

Obtain pharmaceuticals export permit (2)

31 Apply for export permit

32 Obtain export permit

Pre-clearance documentation (1)

33 Contract a clearing agent

Obtain EU certificate of origin (6)

34 Request for certificate of origin

35 Pay for certificate of origin

36 Obtain certificate of origin form

37 Typesetting of the certificate of origin

38 Submit certificate of origin for signing

39 Request for certificate of origin

Obtain passed clearance entry (3)

40 Lodge a customs entry

41 Pay for airline concession fees

42 Obtain passed entry

Obtain PPB release (2)

43 Submit clearance documents for verification

44 Verification of consignment

Obtain Port Health Services release (6)

45 Apply for export health certificate and generate an e-slip

46 Pay for export health certificate

47 Submit clearance documents for verification

48 Physical verification of consignment

49 Obtain export health certificate

50 Obtain Port Health Services release

Obtain KRA release (4)

51 Submit clearance documents for verification

52 Physical verification of consignment

53 Export pharmaceutical products

54 Obtain certificate of export number

12

Inspection of premises
(last modified: 29/07/2021)

Timeframe ( see details )

Waiting time until next step

0 mn - 0 mn

1 day - 5 days

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

Pharmacy Practice and Regulation of Training 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. Wilbur Kariuki

Inspector
Tel: +254 203 562 107
Email: wgachoki@pharmacyboardkenya.org

What do I get?

Premise inspection findings

What documents do I need to bring?

1.

Academic qualification (copy)
The personnel should have the education, training experience or combination of these elements that will allow them to effectively discharge their responsibility.

2.

Operations records (copy)
Should describe the different operations which may affect the quality of the products or of the distribution activity.

3.

Stock control records
Proper documentation of all stocks including damaged goods,returned goods, outward stock and inward stock.

4.

Complaint's management system
All complaints should be forwarded through the right channels and must be addressed.

5.

Storage facilities
Storage conditions of goods and labels should be compatible. All pharmaceuticals should be stored off the floor. Special storage facilities for drugs that require special conditions should be present.

6.

Mode of transport
Transportation of drugs should be hygienic and should be as per the labeling conditions.

7.

Buildings and grounds
Should be secure, safe, well ventilated, hygienic have adequate lighting and should have a good waste disposal plan.

8.

Measures in place to prevent the sale of counterfeit, expired drugs and unregistered drugs
These drugs must be separated from the rest to avoid confusion and selling of harmful drugs to traders.

9.

Physical presence
Of the owner or a representative.

Time frame

The time taken to carry out inspection depends on the size of the premises.

Attention at counter: Min. 30mn - Max. 1h.

Waiting time until next step: Min. 1 day - Max. 5 days

Legal justification

1.

Guidelines for good distribution practices for phamarceuticals

2.

The Pharmacy and Poisons Act CAP 244
Sections 23, 27

Additional information

The applicant, together with the inspector, will be required to sign on the inspection findings.

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

Pharmacy Practice and Regulation of Training 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