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Steps (69) arrow_drop_up arrow_drop_down
Register with Pharmacy and Poisons Board (PPB) online service portal  (3) expand_more expand_less
Obtain wholesale dealer's licence and certificate of premise registration  (6) expand_more expand_less
Register with KESWS  (4) expand_more expand_less
Obtain drug sample permit  (3) expand_more expand_less
Drug sample clearance  (6) expand_more expand_less
Obtain certificate of analysis  (4) expand_more expand_less
Obtain certificate of good manufacturing practices  (5) expand_more expand_less
Obtain product registration certificate  (4) expand_more expand_less
Obtain pharmaceutical import permit  (5) expand_more expand_less
Obtain import declaration form  (2) expand_more expand_less
Pre-clearance documentation  (4) expand_more expand_less
Obtain passed clearance entry  (3) expand_more expand_less
Obtain KEBS release  (4) expand_more expand_less
Obtain Port Health release  (3) expand_more expand_less
Obtain PPB release  (2) expand_more expand_less
Obtain KRA release  (10) expand_more expand_less
Obtain KRA final release  (1) expand_more expand_less

26
Obtain certificate of analysis
(last modified: 27/07/2021)

Where to go?

Entity in charge

Mission for Essential Drugs Supplies (MEDS)

Mombasa Road, Opposite Nation Press, P.O. Box 00507-78040, Nairobi
Tel: +254 734 600 310 / +254 726 937 222
Email: webmaster@meds.or.ke
Website: www.meds.or.ke

Unit in charge

Reception Counter (MEDS)

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

Contact person

Lillian Mugo

Laboratory Assistant
Tel: +254 719 086 215
Email: lmugo@meds.or.ke

What do I get?

Certificate of analysis

What are the requirements?

1. 01 - Libre deuda de patente
Certificate of analysis authorization letter (original)

Time frame

Waiting time in queue: Min.   10mn - Max.  30mn
Attention at counter: Min.   5mn - Max.   10mn

Legal justification

1. The Pharmacy and Poisons Act CAP 244
The Pharmacy and Poisons Act CAP 244
Section 35K

Additional information

The certificate of analysis is a mandatory requirement during product registration. The trader is therefore required to submit a copy of the certificate to Pharmacy and Poisons Board to facilitate product evaluation.

Recourse: Mission for Essential Drugs Supplies (MEDS)

Entity in charge

Mission for Essential Drugs Supplies (MEDS)

Mombasa Road, Opposite Nation Press, P.O. Box 00507-78040, Nairobi
Tel: +254 734 600 310 / +254 726 937 222
Email: webmaster@meds.or.ke
Website: www.meds.or.ke

Unit in charge

Quality Assurance Department (MEDS)

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

Contact person

Stephen Kigera

Manager, Quality Assurance
Tel: +254 734 600 310 / +254 722 991 131
Email: skigera@meds.or.ke
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