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Steps (54) arrow_drop_up arrow_drop_down
Register with Pharmacy and Poisons Board (PPB) online service portal  (3) expand_more expand_less
Obtain certificate of analysis  (4) expand_more expand_less
Obtain wholesale dealer's licence and certificate of premise registration  (6) expand_more expand_less
Obtain certificate of good manufacturing practices  (6) expand_more expand_less
Obtain product registration certificate  (4) expand_more expand_less
Register with KESWS  (4) expand_more expand_less
Obtain registration letter  (3) expand_more expand_less
Obtain pharmaceuticals export permit  (2) expand_more expand_less
language
language
Pre-clearance documentation  (1) expand_more expand_less
Obtain EU certificate of origin  (6) expand_more expand_less
Obtain passed clearance entry  (3) expand_more expand_less
Obtain PPB release  (2) expand_more expand_less
Obtain Port Health Services release  (6) expand_more expand_less
Obtain KRA release  (4) expand_more expand_less

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: Google maps

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. 01 - Libre deuda de patente
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. 01 - Libre deuda de patente
Operations records (copy)
Should describe the different operations which may affect the quality of the products or of the distribution activity.
3. 01 - Libre deuda de patente
Stock control records
Proper documentation of all stocks including damaged goods,returned goods, outward stock and inward stock.
4. 01 - Libre deuda de patente
Complaint's management system
All complaints should be forwarded through the right channels and must be addressed.
5. 01 - Libre deuda de patente
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. 01 - Libre deuda de patente
Mode of transport
Transportation of drugs should be hygienic and should be as per the labeling conditions.
7. 01 - Libre deuda de patente
Buildings and grounds
Should be secure, safe, well ventilated, hygienic have adequate lighting and should have a good waste disposal plan.
8. 01 - Libre deuda de patente
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. 01 - Libre deuda de patente
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
Guidelines for good distribution practices for phamarceuticals
2. The Pharmacy and Poisons Act CAP 244
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.

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: Google maps

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. Wilfred O. Oguta

Director, Pharmacy Practice & Regulation of Training
Tel: +254 203 562 107
Email: wochieng@pharmacyboardkenya.org, info@pharmacyboardkenya.org
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