Kenya - Apply License to Manufacture of Drugs for Sale

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Procedure

Apply In-Person:

1. To apply for a license to manufacture drugs for sale, an applicant can approach the Pharmacy and Poisons Board Offices to make an application.
2. Here the applicant will be given Application for A Licence To Manufacture Drugs For Sale – Form 21 by the boards licensing officer to fill and submit.
3. Fill in the application and attach the required documents. A list of the required documents can be found under the Required Documents" section of this page. These include: -
   • Identification documents of applicant
   • KRA Pin certificate of applicant and business
   • Company CR12 certificate.
   • Memorandum of understanding
   • Wholesaler Dealers’ License
   • Premise License
   • Clearance from PSK.
   • List of drugs to be manufactured for year the license applies.
   • Details of the chemical composition of drugs to be manufactured
   • Curriculum Vitae of Supervisor Pharmacist.
   • Academic documents of supervisor
   • Current work permit for non-Kenyans
4. Proceed to pay the required application fees and attach the payment receipt to the application document. The application fees to be paid can be found under the "Fees" section of this page.
5. Submit the completed application form, requirement and payment receipt to the Boards officer for inspections, verifications and approval.
6. The board will also review the application regarding any areas of noncompliance with the application requirements which the applicant is required to address.
7. Officers from the National Drug Quality Control Laboratory, will carry out inspection of the manufacturing premises and sample any medicinal substance under production and certify that the method of manufacture approved by the Board is being followed.
8. After inspections and verifications, recommendations will be sent to the licensing officer for further review/action.
9. Upon successful review and approval, the licensing officer will be issue the applicant with the license to manufacture drugs for sale.
10. The whole process usually takes 30 days to complete.

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Required Documents

• Identification documents of applicant
• KRA Pin certificate of applicant and business
• Company CR12 certificate.
• Memorandum of understanding
• Wholesaler Dealers’ License
• Premise License
• Clearance from PSK.
• List of drugs to be manufactured for year the license applies.
• Details of the chemical composition of drugs to be manufactured
• Curriculum Vitae of Supervisor Pharmacist.
• Academic documents of supervisor
• Current work permit for non-Kenyans

Office Locations & Contacts

Pharmacy & Poisons Board (PPB) - Head Office
P.O. Box 27663 – 00506, Nairobi.
Address: Lenana Road Opp. DOD
Reception: +254 709 770 100
General Enquiries +254 709 770 100
General Enquiries:[email protected]
Pharmacy Questions:[email protected]
Report a Medicine Problem:[email protected]
About this website:[email protected]
Pharmacy and Poisons Board Contacts
Pharmacy and Poisons Board Website

Eligibility

• Individuals who wish to manufacture any medicinal substance for sale in Kenya is eligible to make the application.

Fees

• Fee for a license to manufacture drugs per product Ksh. 5,000.

Validity

• The validity period is one year.

Documents to Use

• A sample of the Application for A Licence To Manufacture Drugs For Sale – Form 21 can be found in page 89 of the following document link .

Sample Documents

Please attach sample completed documents that would help other people.

Processing Time

• The processing time is 30 days.

Related Videos

Videos explaining the procedure or to fill the applications.
Attach videos using the following tag <&video type="website">video ID|width|height<&/video&> from external websites.
Please remove the "&" inside the tags during implementation.
Website = allocine, blip, dailymotion, facebook, gametrailers, googlevideo, html5, metacafe, myspace, revver,
sevenload, viddler, vimeo, youku, youtube
width = 560, height = 340, Video ID = Can be obtained from the URL of webpage where the video is displayed.
e.g In the following url "http://www.youtube.com/watch?v=Y0US7oR_t3M" Video ID is "Y0US7oR_t3M".

Instructions

• Each manufacturing licence shall expire on the 31st December of every year and the renewal thereof shall be subject to compliance with conditions prescribed by the Board.
• 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.
• The Director of the National Drug Quality Control Laboratory or any member of the Laboratory staff authorized by him shall have power to enter and sample any medicinal substance under production in any manufacturing premises and certify that the method of manufacture approved by the Board is being followed.

Required Information

• Name of applicant
• Contact address
• Business name
• Business registration number
• Name of drugs to be manufactured
• composition of drugs to be manufactured.
• Details of supervisor (Name/ contacts/ qualifications)
• Location of Premises of manufacturing

Need for the Document

• Holders of this license are allowed to manufacture drugs for sale in Kenya.
• No person can manufacture any medicinal substance unless they have been granted a manufacturing license by the Board.
• No person can manufacture any medicinal substance for sale unless he has applied for and obtained a licence from the Board in respect of each substance intended to be manufactured.

Information which might help

• “Manufacture” means any process carried out in the course of making a product or medicinal substance and includes packaging, blending, mixing, assembling, distillation, processing, changing of form or application of any chemical or physical process in the preparation of a medicinal substance or product; but does not include dissolving or dispensing the product by diluting or mixing it with some other substances used as a vehicle for administration.

Other uses of the Document/Certificate

Please explain what are other uses of obtaining this document/certificate.
e.g. Birth Certificate can be used as proof of identity.

External Links

• PHARMACY AND POISONS ACT

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.