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

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How to Apply License to Manufacture of Drugs for Sale in Kenya by Kenyans247(m): Tue Jan 2020 08:14am
Procedure
To apply for 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
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
Any person who intends to manufacture a medicinal substance shall make an application in the prescribed form for the licensing of the premises; and the application shall be accompanied by the prescribed fee.


Fees
KSHS 5000 Per Product


Validity
Each manufacturing license shall expire on the 31st December of every year and the renewal is subject to compliance with conditions prescribed by the Board

Processing Time
30 days


Instructions
No person shall manufacture any medicinal substance for sale unless he has applied for and obtained a license from the Board in respect of each substance intended to be manufactured.



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
No person is allowed to manufacture any medicinal substance unless he has been granted a manufacturing license by the Pharmacy and Poisons Board.

External Links
Manufacturing License http://www.businesslicense.or.ke/index.php/license/details/id/522

Pharmacy and Poisons Board, Kenya http://pharmacyboardkenya.org/

Pharmacy and Poisons Act http://pharmacyboardkenya.org/downloads/?file=PharmacyandPoisonsAct17of1956.pdf



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
Request a Procedure

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