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You are here : Country Regulations
PHARMACEUTICAL REGULATIONS IN KENYA
1. Pharmacy premises and ownership
- Any person(s) who wants to apply for registration of premises shall do so in writing and upon completion of the prescribed forms and provision of the documents prescribed in these guidelines or as may be prescribed by the Board.
- One person shall only be eligible to superintend over one registered premise.
- A reasonable distance shall be maintained between any two registered premises to discourage unfair competitive trade practices.
- A body corporate/ limited liability company may apply to operate more than one premise (as branches). However the requirements stipulated under section 21 of the Pharmacy and Poisons Act must be adhered to including that in each set of premises there shall be a different superintendent pharmacist working under the supervision of the overall responsible company pharmacist.
- Where such superintendent is not a shareholder in the company, the pharmacist can formally be appointed in writing and a written acceptance letter will be recognized as legally binding provided the company pharmacist is the majority shareholder having controlling shares in the company.
- The board shall be notified in writing at least 30 days prior to any changes affecting the following being implemented:
a) Change of ownership- includes change in share distribution, change of directors etc
b) Superintendent/ responsible pharmacist/ pharmaceutical technologist
c) Change in registered premises i.e. change in location, plot number, building etc.
d) Nature of business- wholesale/ retail
e) Change from business of a pharmacist to business of a pharmaceutical technologist and vice versa.
f) Any other significant changes
2. Ownership and basic requiremnts
In addition to the information and documentation provided by the applicant, the Pharmacy and Poisons Board may conduct or cause to be conducted a search of the records kept by the Registrar of Companies to verify the registered owners of any establishment/business making an application for registration of premises or Wholesale Dealer’s License.
3. Premises for pharmacists
A pharmacist can own the business as either
i. A sole proprietor or
ii. A partnership or
iii. A limited company.
In cases (ii) and (iii) above., the superintendent pharmacist must be the majority shareholder and proof of the same attached in the form of an affidavit for case (ii) or articles and memorandum of association for case(iii).
Any one 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 31st day of December in the year it is issued and, if not renewed, the registration shall become void.
Click on this link for more information www.pharmacyboardkenya.org
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