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Kenya - Renew License to Manufacture of Drugs for Sale

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ProcedureEdit

Apply In Person

  1. All licenses issued by the Pharmacy and Poisons Board and expiring on the 31st day of December of the year it is issued will be renewable annually, Applications should be done atleast one month before the expiry of current license. Please view the board’s contact details through this Pharmacy and Poisons Board Contacts.
  2. Application for renewal of licences will be made to the Board in writing by filling the forms obtainable at Pharmacy and Poisons Board offices.
  3. Complete the application form correctly and prepare an electronic copy of MS Word on a CD-ROM which should be cross-referenced to the application by clearly showing the title and section number of all the supporting documents.
  4. Then attach all the supporting documents as mentioned in the “Required Documents” section below to the duly filled application form and the prepared CD-ROM in a single file.
  5. Then the applicant should pay the renewal fees by drawing a cheque to the Pharmacy and Poisons Board and then attaching the cheque to the application file.
  6. Then the applicant should submit the application to the Pharmacy and Poisons Board office at this address: The Registrar, Pharmacy and Poisons Board Lenana Road, P. O. Box 27663-00506, NAIROBI, KENYA.
  7. Upon receipt of the application dossier, the board will evaluate the application file and the applicant will be advised in writing on whether the application was successful or not.
  8. During the document evaluation phase, the Board may arrange for a Good Manufacturing Practices inspection of the manufacturing site in case of quality issues in the market.
  9. Having considered all factors and matters relating to the application the Board will either;
  10. Issue a license to manufacture of drugs for sale or,
  11. Advise the applicant in writing, in case of an unsuccessful application, and clearly state the reason the application was unsuccessful.
  12. After a successful document evaluation phase has been completed satisfactorily, which is within 14 working days of receipt of the application. The applicant will be sent a notification approval.
  13. Applicant will be required to collect the license at the Pharmacy and Poisons Board office. Note: While collecting the license the applicant will be required to produce their identity document an approval letter to be validated by the Registrar's office.


Apply Online Step 1: Register with the Pharmacy and Poisons Board (PPB) Online Services Portal (for new applicants)

  1. Applicants should browser the PPB Online Services Portal
  2. On the Home page, hover the mouse cursor over the “Create Account” tab, to register for an account.
  3. This will navigate the user to the registration page, there are two types of registration processes that a user can use i.e “ Regulated” or “Non-Regulated”.
  4. To register using the Non-Regulated option, applicants should Populate all the available fields accurately on the LTR/Company Registration page before clicking on the “Create Account for LTR” tab. Follow prompts as explained on the left side of the homepage. This option is to be used by registered businesses or companies.
  5. To register using the Regulated option; PPB Practice Registration Portal the applicants should be a medical practitioner registered with the Pharmacy and Poisons Board (PPB). Populate all the available fields accurately before clicking on the “Register For Online Services” tab.
  6. Upon successful submission of the registration request, the applicant will receive a Registration submission notification on their device.
  7. Upon receipt of the registration request, the Pharmacy and Poisons Board (PPB) registration office will start the vetting process to ensure that the applicant is a legitimate company. After approval, the PPB system will forward an email with the credentials that will be sent to the user's registered email address to facilitate access to the portal.


Step 2: Login and apply online

  1. Once logged in the portal, the applicant will be required to complete the creation of his or her profile and then navigate on the dashboard to find the online application form for renew license to manufacture of drugs for sale and populate all the available fields accurately and then upload all the necessary documents against all the upload tabs then save to continue to the payment section.


Step 3: PPB payments and downloads

  1. Upon uploading all the required documents, the system will auto-generate an invoice for the applicant to pay due fees.
  2. Click on the payments page and follow all instructions to satisfy the proper channeling of the registration documents payments. Once payment is received the PPB portal will provide the applicant with a receipt
  3. After a successful document evaluation phase has been completed satisfactorily, which is within 14 working days of receipt of the application. the applicant will be sent a notification approval.


Step 4: Inspection of the premises.

  1. The board will conduct a Good Manufacturing Practices inspection of the manufacturing site in case of quality issues in the market
  2. During the inspection visit, the owner or a representative should be present and should supply the inspector with all requested documentation,
  3. The applicant, together with the inspector, will be required to sign on the inspection findings. A copy of the inspection finding will be issued to the applicant, any discrepancies will be brought to the attention of the applicant and corrective action must be taken before the facility is registered and licensed by the Board.


Step 5: Obtain the license.

  1. Upon approval by the board, applicants will be notified by email and the license will be sent to the applicant to print.
  2. The system will also email the applicant with a guide instruction on how to access and download the license.


Check Application Status

  1. To view application status, the applicant should browse the PPB Online Service Portal and click on the “License Status” hyperlink located on the bottom of the homepage.
  2. This will navigate the License Status page, select the “Cadre/Type” then feed in the “Registration Number” to search and track the status of the application.



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Required DocumentsEdit

  • Copy of previous License to manufacture drugs for sale.
  • Copy of Wholesaler Dealers’ License.
  • Copy of Premise License.
  • Copy of previous annual practice license for the pharmacis.t
  • Clearance of pharmacist from PSK.
  • List of drugs to be manufactured for year the license applies.
  • Current work permit for non-Kenyans.
  • Any other requirements that may be prescribed by the Board from time to time



Office Locations & ContactsEdit

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

EligibilityEdit

  • Individuals with valid a Drug Manufacture license who wish to continue with the manufacturing of medicinal substance for sale in Kenya is eligible to make the application.



FeesEdit

  • Renewal Fees for a license to manufacture drugs per product is Ksh. 5,000.00



ValidityEdit

  • The validity period of the license is one (01) year, unless suspended, revoked or cancelled by the board.
  • 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.
  • Any application for renewal of licenses that is lodged later than 31st December will attract a penalty for late application and this will be in the form of a percentage of the standard application fees as may be prescribed by the Board. Currently the penalty is 10% and is levied on a monthly incremental basis from January onwards.



Documents to UseEdit

Please attach documents that can be used by people. e.g. links



Sample DocumentsEdit

Please attach sample completed documents that would help other people.



Processing TimeEdit

  • The processing time is 14 days.



Related VideosEdit

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 dkisplayed.
e.g In the following url 'http://www.youtube.com/watch?v=Y0US7oR_t3M' Video ID is 'Y0US7oR_t3M'.



InstructionsEdit

  • 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.



Required InformationEdit

  • Applicant’s Name ( Reg. No /Email address/Cell Phone No /ID/Passport/Alien ID No /Nationality)
  • Premise Name & Address.
  • Premise Location: (County/Town /Road/ Building)
  • Current license details
  • Declaration by the applicant



Need for the DocumentEdit

  • 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 helpEdit

  • “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/CertificateEdit

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



External LinksEdit

Pharmacy and Poisons Act


OthersEdit

More information which might help people.



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