Pharmacy Premise License Requirements in Kenya, Licencing Body & Contacts
Executive Summary
- All pharmaceutical premises in Kenya must be licensed by the Pharmacy and Poisons Board (PPB)
- Licensing is governed by the Pharmacy and Poisons Act, Cap 244 Laws of Kenya
- Superintendent must be a registered pharmacist or enrolled pharmaceutical technologist with minimum 3 years experience
- Premises categories include pharmacies (retail/wholesale), manufacturing facilities, and hospital pharmacies
- Business must be legally registered in Kenya (sole proprietor, partnership, or limited company)
- Floor plans required for dispensary, dispensing room, and consultation room
- One superintendent can only oversee one premise at a time
- Licenses must be renewed annually before December 31st
- The PPB is located along Lenana Road, Nairobi
- Contact: +254 726 243 005, +254 780 496 588, +254 738 496 588
The Regulatory Framework
The Pharmacy and Poisons Board is committed to ensuring the availability of pharmaceutical services in Kenya through proper regulation of pharmaceutical premises. It is imperative that pharmaceuticals are distributed by highly qualified personnel through outlets that are duly licensed and professionally run.
Types of Pharmaceutical Premises
Premises Categories
- Premises for carrying on the business of a pharmacist
- Premises for pharmacy business as either wholesale OR retail (not both)
- Premises for carrying on the business of a pharmaceutical technologist
- Premises for manufacturing pharmaceutical drugs
- Hospital pharmacies with resident medical practitioners
When a person wishes to carry out both retail and wholesale business, separate applications must be lodged for different premises, each with a designated superintendent.
Licensing Requirements
Superintendent Requirements
A duly registered and licensed pharmacist or pharmaceutical technologist who can own the business as either:
- Sole proprietorship
- Partnership (superintendent must be majority shareholder with proof via affidavit)
- A registered company engaged in manufacture/distribution of drugs or poisons
Pharmaceutical Technologist Superintendents: Must have minimum 3 years post-enrollment experience. One person can only superintend one premise at a time.
Business Registration
The application will be declined if the business is not a legally recognized entity in Kenya under the Companies Act, 2015 or other relevant laws. Required documentation varies by business type:
| Business Type | Required Documents |
|---|---|
| Sole Proprietorship | BN3 (Business Name Registration) |
| Partnership | BN3 or Partnership Deed |
| Private Limited Company | Certificate of Incorporation + CR12 Form |
Premises Requirements
Physical Space Requirements:
- Floor plan of Dispensary
- Floor plan of Dispensing Room
- Floor plan of Consultation Room
- Suitable physical premises meeting PPB standards
- Compliance with Good Distribution Practice guidelines
Application Documents
For Pharmacist-Run Premises:
- Completed application form
- Letter of appointment of Superintendent Pharmacist
- Academic certificates of superintendent pharmacist
- Copy of PPB Registration Certificate
- Clearance by professional body in Kenya
- Two colored passport-size photographs
- Floor plans (dispensary, dispensing room, consultation room)
- Business registration documents
For Pharmaceutical Technologist-Run Premises:
- Completed application form
- Copies of academic certificates (Diploma in Pharmacy)
- Copy of Enrollment Certificate by PPB
- Business registration documents
- Two colored passport-size photographs
- Floor plans
Application Process
Step-by-Step Procedure
- Ensure business is legally registered in Kenya
- Appoint qualified superintendent (pharmacist or pharm tech with 3+ years experience)
- Prepare premises meeting PPB standards
- Complete application form with all required documents
- Submit application online via PPB portal or in person
- Pay prescribed fees
- Await PPB inspection of premises
- Address any deficiencies noted during inspection
- Receive premises license upon approval
Important Notes
- Superintendent must be registered pharmacist or enrolled pharmaceutical technologist in good standing
- Applicant should be resident in Kenya and must collect license in person
- License expires December 31st annually regardless of issue date
- Operating without valid license may lead to legal/regulatory actions
License Fees
| Service Type | Fee Range (KES) |
|---|---|
| New Premises License | Variable |
| Annual Renewal | Variable |
| Late Renewal Penalty | As prescribed |
| Amendment/Change | Variable |
Pharmacy and Poisons Board Contact Information
Physical Address:
Pharmacy & Poisons Board House
Lenana Road, opposite DOD offices
Nairobi, Kenya
Postal Address:
P.O. Box 27663-00506, Nairobi
Contact Details:
Phone: +254 726 243 005, +254 780 496 588, +254 738 496 588
Email: info@pharmacyboardkenya.org
Website: www.pharmacyboardkenya.org
Portal: portal.pharmacyboardkenya.org
