The Pharmacy and Poisons Board (PPB or the Board in short) is the Drug Regulatory Authority established under the Pharmacy and Poisons Act, Chapter 244 of the Laws of

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. The Board regulates the Practice of

Pharmacy Pharmacy is the science and practice of discovering, producing, preparing, dispensing, reviewing and monitoring medications, aiming to ensure the safe, effective, and affordable use of medication, medicines. It is a miscellaneous science as it ...

and the Manufacture and Trade in drugs and

poison Poison is a chemical substance that has a detrimental effect to life. The term is used in a wide range of scientific fields and industries, where it is often specifically defined. It may also be applied colloquially or figuratively, with a broa ...

Mandate

The Pharmacy and Poisons Act, Cap 244 is an

Act of Parliament Acts of Parliament, sometimes referred to as primary legislation, are texts of law passed by the legislative body of a jurisdiction (often a parliament or council). In most countries with a parliamentary system of government, acts of parliame ...

to make better provision for the Control of the Profession of Pharmacy and trade in drugs and poisons. The Pharmacy and Poisons Board is established as a

body corporate In law, a legal person is any person or 'thing' (less ambiguously, any legal entity) that can do the things a human person is usually able to do in law – such as enter into contracts, sue and be sued, own property, and so on. The reason for ...

, under the Pharmacy and Poisons Act, Cap 244 Laws of Kenya. The PPB is regulatory body within the Ministry of Medical Services. It is a body corporate under Section 3(6), and the de-linking process is on-going.

Membership of the Board

The board members consists of the following: (a) Chairman – Director of Medical Services (b) Registrar – Chief Pharmacist (c) Director of Veterinary Services or Veterinary Surgeon nominated by him. (d) Four Pharmacists nominated by the Pharmaceutical Society of Kenya of whom • One shall be from the Civil Service • One shall be from Community Pharmacy • One shall be from the Pharmaceutical Industry (e) A representative from the Faculty of Pharmacy

University of Nairobi The University of Nairobi (uonbi or UoN; ) is a collegiate research university based in Nairobi. It is the largest university in Kenya. Although its history as an educational institution dates back to 1956, it did not become an independent univer ...

. (f) A Pharmaceutical Technologist (g) Two medical practitioner appointed by Kenya medical association (KMA)

Services

The Board offers the following services: 1. Product Evaluation and Registration. Certificates of Analysis are issued by three accredited laboratories namely the National Quality Control Laboratory, MEDS and the Drug Analysis and Research Unit, 2. Evaluation of Applications for Advertisements of Medicines and Medical Devices 3. Ensuring Good Manufacturing Practice (GMP) 4. Registration of Pharmacists 5. Enrolment of Pharmaceutical Technologists 6. Issuance of Annual Practice Licenses 7. Issuance of Annual Permits for Pharmaceutical Representatives 8. Approval of Institutions Offering Pharmacy Training Programmes 9. Approval of Pharmaceutical Imports and Exports 10. Registration of Pharmaceutical Premises/Outlets 11. Pharmacovigilance and Post-Market Surveillance 12. Documentation and Information Services on Medicines and Pharmacy Practice 13. Public relations services for the pharmaceutical sector

Functions of the Board

The functions of the Board as spelt out by law are as follows: *To advice the

Minister of Health A health minister is the member of a country's government typically responsible for protecting and promoting public health and providing welfare and other social security services. Some governments have separate ministers for mental health. Coun ...

on all matters relating to administration and implementation of the law. *To ensure that all

medicinal product A medication (also called medicament, medicine, pharmaceutical drug, medicinal drug or simply drug) is a drug used to diagnose, cure, treat, or prevent disease. Drug therapy (pharmacotherapy) is an important part of the medical field and rel ...

s manufactured in, imported into or exported from the country conform to prescribed standards of quality, safety and efficacy and that the personnel, premises and practices employed to manufacture, promote, procure, store, distribute and sell such products comply with defined

codes of practice A code of practice can be a document that complements occupational health and safety laws and regulations to provide detailed practical guidance on how to comply with legal obligations, and should be followed unless another solution with the same ...

and other requirements. *To ensure continued conformity of medicinal products with set standards until their delivery to the

end user In product development, an end user (sometimes end-user) is a person who ultimately uses or is intended to ultimately use a product. The end user stands in contrast to users who support or maintain the product, such as sysops, system administrato ...

. *To ensure that medicinal products are imported, manufactured, exported, stocked, sold, distributed or otherwise dealt with by duly authorised persons. *To grant after due assessment, licences/authorisations for medicinal products, whether locally manufactured or imported and whether destined for the national market or export. *To revoke the registration/authorisation of, or cause to be recalled from the market, such medicinal products and the continued use of which may be detrimental to

public health Public health is "the science and art of preventing disease, prolonging life and promoting health through the organized efforts and informed choices of society, organizations, public and private, communities and individuals". Analyzing the det ...

. *To maintain an

inventory Inventory (American English) or stock (British English) refers to the goods and materials that a business holds for the ultimate goal of resale, production or utilisation. Inventory management is a discipline primarily about specifying the sha ...

of registered medicinal products. *To publish lists of registered medicinal products and of products with marketing authorisations from time to time for public information. *To ensure that registration dossiers for medicinal products are kept up to date by the applicants and to approve alternations/changes thereto. *To inspect and license/authorise all manufacturing premises, importing agents, wholesalers, distributors, hospitals,

dispensaries A dispensary is an office in a school, hospital, industrial plant, or other organization that dispenses medications, medical supplies, and in some cases even medical and dental treatment. In a traditional dispensary set-up, a pharmacist dispense ...

, pharmacies and

retail outlets Retail is the sale of goods and services to consumers, in contrast to wholesaling, which is sale to business or institutional customers. A retailer purchases goods in large quantities from manufacturers, directly or through a wholesaler, and t ...

. *To provide for sampling and analysis and other testing of finished medicinal products released into the distribution chain to assure their compliance with labelled specifications *To monitor the market for the presence of illegal/

counterfeit To counterfeit means to imitate something authentic, with the intent to steal, destroy, or replace the original, for use in illegal transactions, or otherwise to deceive individuals into believing that the fake is of equal or greater value tha ...

medicinal products. *To ensure that the promotion and marketing of medicinal products is in accordance with product information as approved by the Board. *To disseminate information on medicinal products to the Professions to promote their rational use. *To monitor and review the implementation of the legislation on pharmaceutical products. *To advise the Minister on matters concerning control and registration of medicinal products. *To amend the rules and regulations as deemed necessary to keep pace with time demand(s). *To register

pharmacist A pharmacist, also known as a chemist (Commonwealth English) or a druggist (North American and, archaically, Commonwealth English), is a healthcare professional who prepares, controls and distributes medicines and provides advice and instructi ...

s after due assessment and maintain the list of registered pharmacists. *To enroll pharmaceutical technologists after due assessment and maintain the roll of enrolled pharmaceutical technologists. *Inspect all institutions' training pharmaceutical programmes for the purpose of approval and retention in the PPB register.

Registration of Pharmacists and Enrollment of Pharmaceutical Technologists

The process is done through administration of a professional examination to the persons with degree and diploma certificates from institutions recognised by Pharmacy and Poisons Board. There are two types of examinations for each group namely; (i) Stage I and II for pharmacist (ii) Level I and II for Pharmaceutical Technologist Stage I examinations – This is administered to persons with degree from universities outside Kenya. When one pass he/she proceeds for a one-year

internship An internship is a period of work experience offered by an organization for a limited period of time. Once confined to medical graduates, internship is used practice for a wide range of placements in businesses, non-profit organizations and gover ...

, supervised by Pharmacy and Poisons Board. Stage II Examination- This is administered to persons from University of Nairobi after completing one-year internship supervised by PPB and Stage I group upon completion of one-year internship. The pharmacists that pass Stage II exams are entered into the pharmacists register. Level I examination – This administered to persons with diploma obtained in colleges (i) outside Kenya and (ii) approved by Pharmacy and Poisons Board other than Kenya Medical Training College. Once one passes the exam, they proceed to a seven months practical attachment supervised by PPB. Level II examination – This is administering to persons for KMTC and those that have finished the seven-month attachment. Upon passing this the name of pharmaceutical technologist is entered into the Roll of Pharmaceutical Technologist.

Annual Practice License

Registered pharmacists and enrolled pharmaceutical technologists are legally required to hold an annual practice licence when working. This is obtained from PPB an application using a prescribed form, and issued by Training and Assessment department.

References

External links

Pharmacy and Poisons Board Official Website

The Official Government of Kenya Law Website
{{DEFAULTSORT:Pharmacy And Poisons Board Government of Kenya Medical and health organisations based in Kenya Drugs in Kenya