Registration of a Pharmaceutical Business in Kenya

Registration of a Pharmaceutical Business in Kenya

The pharmaceutical industry in Kenya is growing at a rapid pace and offers excellent opportunities for manufacturers, distributers and exporters to establish their products and services. Kenya has a significant, and growing, domestic pharmaceutical market. The distribution of pharmaceutical products has been increasing due to the rising disease burden in the country.

Kenya is currently the largest producer of pharmaceutical products in the Common Market for Eastern and Southern Africa (COMESA) region.

The Pharmaceutical industry and business is a highly controlled/regulated industry which has quite a number of governing Laws and Regulations which include but are not limited to the following:-

• The Pharmacy and Poisons Board of Kenya regulates the trade in medical products and health technologies. We have the Pharmacy and Poisons ACT, CAP 244 laws of Kenya which makes provision for the control of the Pharmaceutical Profession and the trade in drugs and poisons.
• The “Guidelines for Evaluation and Assessment for a Pharmacist” by the Pharmacy and Poisons Board (PPB) outline the criteria and prerequisite for registration as a Pharmacist in Kenya.
• Pharmaceutical products are distributed by highly qualified personnel through outlets that are duly licensed and professionally run. Pharmaceutical products require specialized handling to ensure their quality is maintained throughout the distribution chain and the risk of exposing the public to unsafe medicines should be avoided at all cost.
• The Guidelines for good distribution practices for medical products and health technologies in Kenya (2019) provide persons involved or wishing to be involved in distribution Medical products and health technologies with a method of assessing eligibility and the process of lawfully operating distribution outlets. It further provides specific requirements on distribution that are practices currently acceptable.

The pharmaceutical industry consists of three players namely:

• Manufacturers;
• Distributors and
• Retailers.

The Kenya Association of Pharmaceutical Industries (KAPI) was established in the 1960’s to promote high standards in the pharmaceutical industry.

In this article, we shall focus on registration of distributors and retailers of pharmaceutical products.

Who can operate a pharmaceutical business?

1. A duly registered and licensed pharmacist or a Pharmaceutical Technologist who can own the business as either:
2. A sole proprietor
3. A partnership with a person/company for which the superintendent pharmacist must be the majority shareholder and proof of the same attached in the form of an affidavit.
4. A company that is engaged in the manufacture and or distribution of a drug or poison.
5. A representative of a person engaged in the sale and supply of pharmaceuticals subject to being issued with of a permit by the Board
6. any duly qualified medical practitioner, dentist or veterinary surgeon who satisfies the Board that he is urgently in need of a drug or poison which he is unable to obtain in Kenya;
7. A hospital at and of which a medical practitioner registered under the Medical Practitioners and Dentists Act (Cap. 253), is resident and in direct control.

Which premises can be registered for pharmaceutical operations in Kenya? 

• Premises for carrying on the business of a pharmacist.
• Premises for carrying on the business of a pharmacy as either wholesale or retail but not 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.
• Premises for carrying on the business of a pharmaceutical technologist.
• Premises for manufacturing pharmaceutical drugs.
• A hospital at and of which a medical practitioner registered under the Medical Practitioners and Dentists Act (Cap. 253), is resident and in direct control.

Application for Retail pharmacy licence in Kenya

1. The applicant:
2. Should be a registered pharmacist with the Pharmacy and Poisons Board.
3. Should be an enrolled Pharmaceutical technologist with the Pharmacy and Poisons Board, with three years post enrolment experience.
4. Should not be a holder of another such licence for a different premise.
5. Should not be engaged as a pharmacist/pharmaceutical technologist in any other enterprise.
6. The premises has been certified for suitability by the Pharmacy and Poisons Board’s inspectorate department.
7. Payment of the prescribed fee.

For sole proprietorship

In addition to the above requirements, include a Copy of Certificate of registration/incorporation of the company name (Form BN/3) from the Registrar of companies, Attorney General’s office.

For partnerships

In addition to the above mentioned documents, include

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

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.

Requirements and Documentation

• A duly completed application form
• Copies of academic certificates of the superintendent pharmaceutical technologist.
• A copy of Diploma certificate in Pharmacy must be included.
• A Copy of Enrolment Certificate by Pharmacy & Poisons Board, Kenya, for the superintendent pharmaceutical technologist.
• Superintendent pharmaceutical technologist’s resignation letter to the last employer
• Letter of appointment of Superintendent Pharmaceutical technologist by the company applying for registration
• Clearance by a professional body, Kenya.
• Two colored passport size photographs.
• Floor plan of the Dispensary
• Floor plan of Dispensing Room
• Floor plan of a Consultation room.

Guidelines for the minimum requirements for Setup of the Premises 

• The construction must be of a permanent nature
• 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.
• The premises should be well lit, ventilated and secure.
  The premises should be protected against adverse weather conditions, groundwater seepage, vermin and pest infestation.
  The premises should have sufficient space for the carrying out of the necessary operations.
  There should be no overcrowding of customers and staff thus promoting efficient flow of work, effective communication, and supervision.
• 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.
• The premises must be used exclusively for the business of a pharmacy.
• Premises should have running potable water, toilet facilities, waste disposal system and space dedicated for the storage of cleaning equipment.
• 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.
• 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.
• 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.

Standards of Practice 

No person will be issued with a license to operate a retail pharmacy unless they comply with the requirements and guidelines for registration of premises which include but are not limited to:

• Is a holder of a certificate of Registration or Enrolment from the Pharmacy and poisons Board.
• Is not a holder of another such license for a different premises.
• Is not engaged as a pharmacist/pharmaceutical technologist in any other enterprise.
• Holds a satisfactory inspection report from the Board’s Pharmaceutical Inspectorate.
• Has not been previously convicted of an offense involving wrongful or illegal dealing in supply and/or possession of drugs.
• Pays the prescribed fee.
• The applicant must specify if they intend to carry out the business as importers and or exporters.

Requisite Application FORMS:

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.

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.

Upon submission of the application documents, the applicant shall pay a non-refundable fee.

Fees payable for registration and licensing of a pharmaceutical company in Kenya

Processing of the Application

• 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

• Issue a certificate of registration of premises under part II of the Pharmacy and Poisons Act, Cap 244 Laws of Kenya; or
• 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.

CONCLUSION

The guidelines developed by the PPB aim at ensuring good distribution practices, transportation of pharmaceuticals and also for safe management of pharmaceutical waste. The guidelines are available and all health practitioners are advised to familiarize with the provision of the guidelines.

All parties involved in the distribution of medical products and health technologies have a responsibility to ensure that the quality of the products and the integrity of the distribution chain are maintained throughout the distribution process from the site of manufacture to the entity responsible for dispensing the product to the end user.

With the rise of illegal centres dealing in distribution, transportation and dispensing of pharmaceutical products, members of the public are advised to use the health safety code 21031 displayed in registered pharmacy outlets to verify legality of the premises they are buying medicine from.

If you would like to register a pharmaceutical company in Kenya, please contact us on swanjiru@capitaregistrars.co.ke or by telephone +254709747555