How To Register and Operate a Pharmacy/Chemist in Kenya

To operate a chemist/pharmacy in Kenya is not easy, this is because of many licensing procedures you should follow before you set up the business.

Pharmaceutical business is one of the most profitable business ventures in the world, and in Kenya. In a single day, the average profit of a single chemist in Nairobi is Ksh 4,000-Ksh20, 000, sometimes it can go up to Ksh 50,000-which means you can make a cool Ksh 1 million per month.

But how do you set up a chemist?

The first thing to do is ensure you have a diploma or degree in pharmacy..you cannot operate a chemist without having qualifications in pharmacy from a recognized academic institution in Kenya.

If you possess the outlined qualification, proceed to Pharmacy and Poisons Board for a license. Then go to your county offices for trading license.

A license and set up capital will require Ksh 600,000-Ksh 2 million.

If you don’t possess relevant qualification, you can partner with someone with the qualification. This requires that you draft a partnership deed and register your partnership company.

Besides, you can register a Pharmaceutical company, which require more licenses.

Below we provide details of how you to start a pharmaceutical company in Kenya.

MINIMUM REQUIREMENTS AND STANDARDS OF PRACTICE

The minimum requirements for premises and standards of practice are contained in the Pharmacy and Poisons Board guidelines for Good Wholesaling and Retail Practices for Pharmaceuticals (see separate document).

HOW TO MAKE AN APPLICATION FOR REGISTRATION OF PREMISES

An application for registration of premises shall be made in writing and upon completion of the prescribed forms. The

PPB/Prem & Wholesale v1.0.doc xduly completed application forms are to be submitted accompanied by the documents prescribed in these guidelines (see the checklists) or any other documents as may be deemed necessary or as may be prescribed by the Board.

Application forms are available at the Pharmacy and Poisons Board offices along Lenana Road in Nairobi. The forms can be obtained, free of charge, from the Pharmaceutical Inspectorate Department.

The requisite application forms for retail pharmacy run by a registered pharmacist are:

1. Form 4 (Application for Registration of Premises)
2. Annexe 1 ( Confidential questionnaire designated for premises to be run by pharmacist)

iii.        Form 27(application for annual practice licence) – This is to be filled where the superintendent pharmacist does not yet hold a valid annual practice licence.

The requisite application forms for wholesale pharmacy are:

1. Form 4 (Application for Registration of Premises)
2. Annexes 1 ( Confidential questionnaire designated for premises to be run by pharmacist)

iii.        Form 6- Application for a Wholesale Dealer’s Licence

1. Form 27(Application for Annual Practice Licence) – This is to be filled where the superintendent pharmacist does not yet hold a valid annual practice licence.
2. The applicant will specify if, in addition, they intend to carry out the business as importers and or exporters.

PPB/Prem & Wholesale v1.0.doc xi

1. A wholesale Dealer SHALL BE required to abide with the Good Distribution Practices guidelines set by the Board. Failure to abide by the guidelines may lead to necessary disciplinary action being taken against the affected person(s).

The requisite application forms for retail pharmacy run by an enrolled pharmaceutical technologist are:

1. Form 30 (Application for Registration of Premises for a Pharmaceutical Technologist)
2. Annexe 2( Confidential questionnaire designated for premises to be run by a pharmaceutical technologist)

iii.        Form 29(Application for Licence Practice to Practice as a Pharmaceutical Technologist) – This is to be filled where the superintendent pharmaceutical technologist does not yet hold a valid practice licence.

The completed application form together with the relevant documents indicated in the checklist should be submitted in person to the address below.

The Registrar,

Pharmacy & Poisons Board,

Lenana Road, (Between the Egyptian Embassy and Lenana

Conference Centre)

Nairobi

It may alternatively be sent by post to:

The Registrar,

Pharmacy & Poisons Board

P.O BOX 27663-00506, Nyayo Stadium,

Nairobi.

Upon submission of the application documents the applicant shall pay a non- refundable application fees as stipulated below (current fees) or as may be prescribed by the Board.

CURRENT APPLICATION FEES STRUCTURE

Retail Pharmacy (applies to both premises for a pharmacist and premises for a pharmaceutical technologist)

1. Annual practice licence Kshs. 2500
2. Premises registration fee Kshs. 5000

Wholesale Pharmacy

1. Annual practice licence Kshs. 2500
2. Premises registration fee Kshs. 5000

iii.        Wholesale dealer’s licence           Kshs. 5000.

PROCESSING OF APPLICATIONS

Upon receipt of the duly filled application forms and documents, the same will be evaluated and the applicant advised in writing on whether the application was successful or not. In conducting the evaluation, the Board may arrange an interview for the applicant (superintendent) by the Practice Committee of the Board. If the interview is successful, an inspection of the proposed company’s premises will be conducted by a pharmaceutical inspector to assess the suitability for the intended business. The inspection report will be presented in the prescribed inspection form.

Having considered all factors and matters relating to the application the Board will either

1. Issue a certificate of registration of premises under part II of the Pharmacy and Poisons Act, Cap 244 Laws of Kenya; or PPB/Prem & Wholesale v1.0.doc xiii
2. Advise the applicant in writing, in case of an unsuccessful application, and clearly state the reason the application was unsuccessful.

In the case of an unsuccessful application, the applicant will be given further opportunity to revise and comply. Where the applicant is able to revise the application and comply with the requirements a licence will be issued: otherwise the premises shall remain unregistered and the file will be closed after about 6 months from the date of initial application.

Nothing in these guidelines shall make it lawful to carry out the business in premises which are not registered even when an application is under process but the license has not yet been issued.

VALIDITY OF REGISTRATION CERTIFICATE AND/ OR WHOLESALE DEALER’S LICENCE

The Certificate for Registration of Premises (Form 33) expires on the 31st day of December of the year it is issued. The Wholesale Dealer’s Licence (Form 7) expires on the 31st day of December of the year it is issued

The Certificate for Registration of Premises for a Pharmaceutical Technologist’s Practice (Form 31) expires on the 31st day of December of the year it is issued.

The above expiry dates will apply irrespective of the actual date of issue of the license in question.

RENEWAL OF LICENSES

All licenses issued by the Board and expiring on the 31st day of December of the year it is issued will be renewable annually. Application for renewal of licences will be made to the Board in writing by filling the forms stipulated in part 6 above. However, for purposes of renewal, it shall not PPB/Prem & Wholesale v1.0.doc         xiv

be necessary to fill the annexes except in a situation where there are changes in details that may require variation of license.

Notwithstanding licenses having been issued the previous year, the application for renewal shall be evaluated every time and the Board shall not be obliged to renew the licenses except for applications which as per the prevailing conditions at the time of application still meet the requirements. Premises which, after re-assessment, are deemed to have become unsuitable for carrying on the business will not have their registration renewed and the previous one would automatically become void.

The requisite forms for renewal are to be filled and application fees paid beginning October and not later than 31st December every year in order to facilitate timely processing of the licenses.

PENALTY FOR LATE RENEWAL:

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.