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Steps (63) 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  (2) expand_more expand_less
Obtain EU certificate of origin  (6) expand_more expand_less
Obtain passed clearance entry  (3) expand_more expand_less
Obtain export health certificate  (4) expand_more expand_less
Obtain PPB release  (2) expand_more expand_less
Obtain Port Health Services release  (1) expand_more expand_less
Obtain KRA and KPA release  (12) expand_more expand_less
Obtain export certificate  (1) expand_more expand_less

22
Submit product samples
(last modified: 28/07/2021)

Timeframe ( see details )

Waiting time until next step

10 mn  -  20 mn
90 days  -  365 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

Product Evaluation and Registration Counter (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

Registration Officer (PPB)

Registration Officer
Tel: +254 203 562 107 (Ext. 107)

What do I get?

Acknowledgement of receipt

What documents do I need to bring?

1. 01 - Libre deuda de patente
Pharmacy and Poisons Board (PPB) invoice (copy)
2. 01 - Libre deuda de patente
Pharmacy and Poisons Board (PPB) receipt (copy)
3. 01 - Libre deuda de patente
Drug sample

Time frame

Waiting time in queue: Min.   5mn - Max.  10mn
Attention at counter: Min.   5mn - Max.   10mn
Waiting time until next step: Min.   90 days - Max.   365 days

Additional information

After submission of the samples, evaluation of the product(s) is undertaken which may result into: 1. Rejection - This may result into an appeal by the applicant for review. 2. Querying - This will require provision of further relevant information. 3. Registration - This will result into issuance of the registration certificate for market authorization in Kenya.

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

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
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