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Requirements to Open a Pharmacy in Kenya

by Victor Matara

We all know that pharmacy business in Kenya is always evergreen because it’s not easily affected by economic changes. Besides being a lucrative venture, starting a pharmacy can be really stressful from all the long procedures to the large startup capitalOn this article, we are going to look at the requirements one must meet before opening and operating a pharmacy in Kenya according to the Pharmacy and Poisons Board.

 Types of premises that can be registered for pharmaceutical operations in Kenya. 

a) Premises for a pharmacist – for carrying on the business of a pharmacist.

b) Premises for Wholesale – for carrying on the business of a pharmacist on a wholesale basis only.
c) Premises for a pharmaceutical technologist – for carrying on the business of a pharmaceutical technologist.

A pharmacist can own the business as either :

1.A sole proprietor
2. A partnership
3. A limited company

As a sole proprietor or as a limited company,  the superintendent pharmacist must be the majority shareholder and proof of the same attached in the form of an affidavit.

Any premise for a pharmacist shall be registered as either retail or wholesale business but NOT as both. Where a person wishes to carry out retail and wholesale business then the person shall lodge an application for registration of different sets of premises and each set must have a designated superintendent.
The premises registration automatically expires on the 31st day of December in the year it is issued and, if not renewed, the
registration shall become void.

How to Make an Application For Registration Of Premises

An application for the registration of a premise must be made in writing and upon completion, the duly signed application form and relevant documents are submitted to the nearest Pharmacy and Poisons Board office. Application forms are available at the Pharmacy and Poisons Board offices along Lenana Road in Nairobi. The forms can also be obtained, free of charge, from the nearest Pharmaceutical Inspectorate Department.

Before making an application, please make sure you have these documents and provisions ready:

1. A completed application form

2. Copies of academic certificates of the superintendent pharmaceutical technologist.

A copy of Diploma certificate in Pharmacy must be included.

3. A Copy of Enrolment Certificate by Pharmacy & Poisons Board, Kenya, for the superintendent pharmaceutical technologist.

For sole proprietorship

A Copy of Certificate of registration of company name (Form BN/3) from the Registrar of companies, Attorney General’s office.

For partnerships

  1. A Copy of Certificate of registration of company name (Form BN/3) from the Registrar of companies, Attorney General’s office
  2. An affidavit

 

4. Superintendent pharmaceutical technologist’s resignation letter to the last employer

5. Letter of appointment of Superintendent Pharmaceutical technologist by the company applying for registration

6. Clearance by a professional body, Kenya.

7. Two colored passport size photographs.

8. Floor plan of the Dispensary

9. Floor plan of Dispensing Room

10. Floor plan of a Consultation room

Nature and Setup Of The Premises 

These guidelines will serve as the minimum acceptable requirements for premises, which will be licensed as retail
pharmacies.

1. The construction must be of a permanent nature

2. The floors and walls will be made of washable and impervious materials, and the ceiling covered with a non-flaking finish that allows for easy cleaning.

3. The premises should be well lit, ventilated and secure.
4. The premises should be protected against adverse weather conditions, groundwater seepage, vermin and pest infestation.
5. The premises should have sufficient space for the carrying out of the necessary operations.
6. There should be no overcrowding of customers and staff thus promoting efficient flow of work, effective communication, and supervision.

7. The minimum recommended size for the dispensary shall be 8 feet by 10 feet. For the general shop area, the minimum acceptable will be 10 feet by 10 feet.

8. The premises must be used exclusively for the business of a pharmacy.

9. Premises should have running potable water, toilet facilities, waste disposal system and space dedicated for the storage of cleaning equipment.

10. All products should be protected from light, heat, and moisture and there must be temperature controlled storage facilities for ingredients and drugs, which are sensitive.

11. Pharmacy only drugs must be separated from over the counter drugs and narcotic and psychotropic
drugs shall be kept in a secure fixed and lockable storage place.

12. There should be a separate office or administrative office for the pharmacist, where prescription, purchase records and other administrative records may be maintained and it should be located so as to have a full view of the dispensary.

EQUIPMENT
There should be some basic equipment:
(i) A refrigerator
(ii) Weighing balance
(iii) Measuring cylinders with a capacity to accurately measure volumes between 0
and 100 ml
(iv) Pestle and mortar
(v) Spatula and Slab
REFERENCE BOOKS
The following reference books should be available and they should be the latest or next to latest editions
(i) British National Formulary
(ii) Martindale, the extra pharmacopeia

(iii) Chapter 244, Laws of Kenya
(iv) Code of Ethics
(v) Kenya Standard Treatment Guidelines
(vi) Kenya National Drug Policy
(vii) Lists of drugs that are registered in
Kenya
(viii) Mims
(ix) East African Pharmaceutical Loci or other text that gives trade names of drugs
on the market.

Check Out
Kenyatta University Fees Structure for Undergraduate, Diploma and Certificate Programmes

Standards Of Practice 

No person will be issued a license to operate a retail pharmacy unless the person complies with the
requirements stipulated in the guidelines for registration of premises including, but not limited to,
the following:
a) Is a holder of a certificate of Registration or Enrolment from the Pharmacy and Poisons Board
b) Is not a holder of another such license for a different premises
c) Is not engaged as a pharmacist/pharmaceutical technologist in any other enterprise
d) Holds a satisfactory inspection report from the Board’s Pharmaceutical Inspectorate
e) Has not been previously convicted of an offense involving wrongful or illegal dealing in, supply and/or
possession of drugs
f) Pays the prescribed fee

Operations 

1. The dispensing of prescriptions and sale of pharmacy-only medicine shall be under the supervision of a named pharmacist or pharmaceutical technologist
2. The Pharmacy shall not dispense any prescription or sell any Pharmacy only medicine when the pharmacist is not present.
3. No prescription only medicine is to be dispensed except in compliance with a valid prescription written by a registered Medical Practitioner, Dental Surgeon or Veterinary Surgeon.
4.Every retail pharmacy should keep and use suitable dispensing containers and labels. The container shall be capable of keeping dispensed medicines in a safe and usable condition.
5. A suitable and adequate prescription/patient recording system shall be maintained which shall consist of a prescription record ledger well indexed and up to date. This may be supplemented by patient profile cards, a computerized system or any
other approved recording system.
6. Records of all stocks received their source, batch number, expiry date and quantity received shall be maintained.
7. All records will be retained for a minimum of five years for narcotic drugs and two years for other drugs.
8. All records should be available for inspection by the pharmaceutical inspectorate at all reasonable times
9. The retail pharmacy shall comply with these and any other requirement as may be specified by the Pharmacy and Poisons Board from time to time.

Below are the requisite application forms for a retail pharmacy run by an enrolled pharmaceutical technologist.

1. Form 4 – Application for Registration of Premises

2. Annex 1 – Confidential questionnaire designated for premises to be run by a pharmacist

3. Form 27 -application for annual practice license – This is to be filled where the superintendent pharmacist does not yet hold a valid annual practice license.

Requisite application forms for wholesale pharmacy

1. Form 4 – Application for Registration of Premises

2. Annexes 1 – Confidential questionnaire designated for premises to be run by a pharmacist
3. Form 6- Application for a Wholesale Dealer’s Licence
4. Form 27 – Application for Annual Practice Licence – This is to be filled where the superintendent pharmacist does not yet hold a valid annual practice license.

The applicant must specify if they intend to carry out the business as importers and or exporters.

The completed application form together with the relevant documents indicated above 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

Retail Pharmacy Application Fees  (applies to both premises for a pharmacist and premises for pharmaceutical technologists)

License​​ 

Fees

 

Annual practice licence

 

 

Ksh 2,500

 

Premises registration fee

 

 

Ksh 5,000

 

Wholesale Pharmacy Application Fees 

License​​ 

Fees

 

Annual practice licence

 

 

Ksh 2,500

 

Premises registration fee

 

 

Ksh 5,000

 

Wholesale Dealer’s License

 

 

Ksh 5,000

 

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 with 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
  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 license 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.

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