Kenya - Obtain a Certificate for Pharmaceutical Products

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Procedure

Apply In-Person:

1. Companies importing manufactured drugs from Kenya can request for a Certificate for Pharmaceutical Products (CPP) from the Pharmacy and Poisons Board (PPB) through the exporting pharmaceutical manufacturing company in Kenya.
2. To do this, the Superintending Pharmacist / Pharmacist in Charge of the exporting company in Kenya, can approach the Pharmacy and Poisons Board Offices to make an application.
3. Here the applicant will be given an Certificate of a Pharmaceutical Product form by the boards officer to fill and submit.
4. Fill in the application and attach the required documents for the application. A list of the required documents can be found under the Required Documents" section of this page.
5. Proceed to pay the required application fees and attach the payment receipt to the application document. The details of application fees to be paid can be found under the "Fees" section of this page.
6. Submit the completed application form, requirements and payment receipt to the Boards officer for inspections, verifications and approval.
7. The board will review the application and after inspections and verifications, recommendations will be sent to the Board for further review/action.
8. Upon successful review and approval of the application, the PPB issues a CPP to the importing/applicant company via the exporting company.
9. The process usually takes a period of 30 days to complete.

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Required Documents

• A formal application letter by the Superintending Pharmacist / Pharmacist in Charge of the company, as registered with the Pharmacy and Poisons Board, addressed to “The Registrar, Pharmacy and Poisons Board” detailing the requesting the CPP.
• Filled in application form
• Proof of up-to-date registration of the company
• Proof of up-to-date registration of the product
• List of active ingredients (contents) in the medicine
• Detail of Name and dosage form of the product
• Product license / Marketing Authorization
• Premise license
• Manufacturing license.
• Details of applicant for certificate.
• Inspection certificate of manufacturing plant

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 wishing to import drugs manufactured/packaged in Kenya for sale are eligible to make the application.

Fees

• The CPP issuance fee is approximately 200 USD.

Validity

• The Certificate for Pharmaceutical Product shall be valid for five years.

Documents to Use

• Certificate of a Pharmaceutical Product

Sample Documents

Please attach sample completed documents that would help other people.

Processing Time

• Once an application has been accepted the processing of application will take a maximum of 30 working 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

How the CPP scheme operates

• The certificate recipient authority has in its national medicine legislation or guidelines a requirement for the submission of a Certificate for a Pharmaceutical Product (CPP) for products being imported into the country as a support to ensure the quality of the product being imported. (In some countries the CPP forms part of the dossiers to be submitted to the national medicine regulatory authority (NMRA) to have a product registered by the authority).
• The applicant/importing company requests a CPP from the certifying authority through the exporting company.
• The certifying authority issues a CPP to the importing/applicant company via the exporting company. (At the time of the development of the Scheme the understanding was that a CPP would be sent directly to the recipient authority by the issuing authority.

Required Information

• Exporting (certifying country) name
  
• Importing (requesting country) name
  
• Name and dosage form of the product: (In Kenya: / In importing country (specify the country))
  
• Active ingredient(s) (2and amount(s) per unit dose
  
• Is this product licensed to be placed on the market for use in the exporting country
  
• Is this product actually on the market in the exporting country
  
• Product licence / Marketing Authorization
  
• The name and address of Product licence holder
  
• The names and address of manufacturing/ packaging site where the dosage form is produced (
  
• officially approved product information complete and consonant with the licence
  
• Applicant for certificate, if different from licence holder (name and address)
  
• Does the certifying authority arrange for periodic inspection of the manufacturing plant in which the dosage form is produced?
  
• Do the facilities and operations conform to GMP as recommended by the World Health Organization
  

Need for the Document

• Holders of this permit are allowed to advertise drugs for in Kenya.
• The Certificate for a Pharmaceutical Product (CPP) evidence of quality, safety, efficacy review and approval. The CPP is based on the assumption that the authorities issuing a CPP have the capacity to assess the quality, safety, and efficacy (QSE) of the product they approve for marketing.

Information which might help

• The Certificate for a Pharmaceutical Product CPP is administrative instrument that requires a participating Member State (a certifying country), upon application by a commercially interested party (the applicant company), to certify/attest to the competent authority of another participating Member State (the recipient country) that:
  • a specific pharmaceutical product is authorized for marketing in the certifying country, or if not, the reason why authorization has not been accorded.
  • the manufacturing facilities and operations conform to good manufacturing practices (GMP) as recommended by WHO.

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
• WHO CERTIFICATION SCHEME ON THE QUALITY OF PHARMACEUTICAL PRODUCTS MOVING IN INTERNATIONAL COMMERCE

Others

More information which might help people.