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How to Renew License to Manufacture of Drugs for Sale in Kenya

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How to Renew License to Manufacture of Drugs for Sale in Kenya by Kenyans247(1): Mon 16, March, 2020 10:47am
Procedure
To renew license to manufacture of drugs for sale, the applicant has to contact the Pharmacy and Poisons Board offices.
http://pharmacyboardkenya.org/?page_id=99
The applicant has to make sure he or she has all the required documents that are required for this process to be successful and they can be found under the "Required Documents" section of this page.
Payment of appropriate fees should be made and that can be found under the "Fees" section of this page.
On completion of this process, the Board shall, within 30 days of receipt of the application issue to the applicant a license.

Required Documents
Articles of Association
Copy of Pharmacists I.D
Attorney General Certificate
Personal identification Number
Memorandum of understanding
Copy of previous License to manufacture drugs for sale, Wholesaler Dealers License and Premise License
A copy of previous annual practice license for the pharmacist plus clearance from PSK
List of drugs to be manufactured for year the license applies
Non-Kenyans to attach current work permit

Office Locations & Contacts
The Registrar
Pharmacy and Poisons Board
Lenana Road Opp. DOD

P.O. Box 27663 00506

Nairobi

Telephone:
+254 702 475 824 (8am-5pm) Online Licensing
+254 702 475 845 (8am-5pm) Online Licensing
+254 702 475 837 (8am-5pm) Online Licensing
+254 702 475 842 (8am-5pm) Online Licensing
+254 702 475 801 (8am-5pm) Online Licensing
+254 20 3562107 General Line
+254 720 608811 General Line
+254 733 884411 General Line

Email:
General Enquiries: enquiries@pharmacyboardkenya.org
Pharmacy Questions: info@pharmacyboardkenya.org
Report a Medicine Problem: pv@pharmacyboardkenya.org

Website: http://pharmacyboardkenya.org

Map Location
https://www.google.com/maps/place/Pharmacy+and+Poisons+Board,+Kenya

Eligibility
Licensed manufacturers of drugs for sale


Fees
KSHS 5000 Per Product


Validity
Each manufacturing license shall expire on the 31st December



Documents to Use
Application For Renewal Of A License For Manufacture Of Drugs For Sale
http://pharmacyboardkenya.org/downloads/?file=manufacturer_license_application.pdf

Processing Time
30 days

Instructions
Any person who intends to renew license to manufacture drugs should make an application in the prescribed form for the licensing of the premises; and the application shall be accompanied by the prescribed fee.



Required Information
Applicants name
Reg. No
Email address
Cell phone No
ID/passport/alien ID No
Nationality
Premise name & address
Premise location, county, town, road and building
Signature of the applicant
Other professionals working in this premise

Need for the Document
Each manufacturing license shall expire on the 31st December of every year and the renewal is subject to compliance with conditions prescribed by the Pharmacy and Poisons Board.

Others
The Pharmacy and Poisons Board is the Drug Regulatory Authority established under the Pharmacy and Poisons Act, Chapter 244 of the Laws of Kenya.

The Board regulates the Practice of Pharmacy and the Manufacture and Trade in drugs and poisons.

The Board aims to implement the appropriate regulatory measures to achieve the highest standards of safety, efficacy and quality for all drugs, chemical substances and medical devices, locally manufactured, imported, exported, distributed, sold, or used, to ensure the protection of the consumer as envisaged by the laws regulating drugs in force in Kenya.

Functions of Pharmacy and Poisons Board

Product Registration
Pharmacy Practice
Manufacturing Services
Inspectorate

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