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Summary print

Preview & Print

Properties

Steps (4) arrow_drop_up arrow_drop_down
Obtain product registration certificate  (4) expand_more expand_less

certification bar

1
Apply for product registration
(last modified: 25/10/2019)

You can apply for this step online

language Apply online

Where to go?

Entity in charge

Pharmacy and Poisons Board (PPB) Trade Portal

What do I get?

Pharmacy and Poisons Board (PPB) invoice

What are the requirements?

1. Application for registration of a drug - Form 1
Application for registration of a drug - Form 1 (original)
Filled and signed by the local technical representative.
2. 01 - Libre deuda de patente
Certificate of analysis (copy)
For more information on how to obtain a certificate of analysis,click here .
3. 01 - Libre deuda de patente
Certificate of good manufacturing practices (copy)
For more information on how to obtain a certificate of good manufacturing practice, click here.
4. 01 - Libre deuda de patente
Certificate of pharmaceutical product (copy)
Issued by a competent regulatory authority from the country of origin.

Time frame

Attention at counter: Max.   3h.

Legal justification

1. Pharmacy and Poisons (Registration of Drugs) Rules
Pharmacy and Poisons (Registration of Drugs) Rules
Section 4

Who certified this information ?

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

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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