Pharmacy and Poisons Board
Encyclopedia
Pharmacy and Poisons Board - Kenya
.
The Board regulates the Practice of Pharmacy
and the Manufacture and Trade in drug
s and poison
s.
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, 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.
(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
.
(f) A Pharmaceutical Technologist.
1. Product Evaluation and Registration
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
v To advice the Minister of Health on all matters relating to administration and implementation of the law.
v To ensure that all medicinal product
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 and other requirements.
v To ensure continued conformity of medicinal products with set standards until their delivery to the end user.
v To ensure that medicinal products are imported, manufactured, export
ed, stocked, sold, distributed or otherwise dealt with by duly authorized persons.
v To grant after due assessment, licences/authorizations for medicinal products, whether locally manufactured or imported and whether destined for the national market or export.
v To revoke the registration/authorization of, or cause to be recalled from the market
, such medicinal products and the continued use of which may be detrimental to public health
.
v To maintain an inventory
of registered medicinal products.
v To publish lists of registered medicinal products and of products with marketing authorization
s from time to time for public information.
v To ensure that registration dossiers for medicinal products are kept up to date by the applicants and to approve alternations/changes thereto.
v To inspect and license/authorize all manufacturing
premises, importing agents, wholesalers, distributor
s, hospital
s, dispensaries
, pharmacies and retail outlets.
v 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
v To monitor the market for the presence of illegal/counterfeit medicinal products.
v To ensure that the promotion and marketing of medicinal products is in accordance with product information as approved by the Board.
v To disseminate information on medicinal products to the Professions in order to promote their rational use.
v To monitor and review the implementation of the legislation
on pharmaceutical products.
v To advise the Minister on matters concerning control and registration of medicinal products.
v To amend the rules and regulations as deemed necessary to keep pace with time demand(s).
v To register pharmacist
s after due assessment and maintain the list of registered pharmacists.
v To enroll pharmaceutical technologists after due assessment and maintain the roll of enrolled pharmaceutical technologists.
v Inspect all institutions training pharmaceutical programmes for the purpose of approval and retention in the PPB register.
(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, 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.
Pharmacy and Poisons Board
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 KenyaKenya
Kenya , officially known as the Republic of Kenya, is a country in East Africa that lies on the equator, with the Indian Ocean to its south-east...
.
The Board regulates the Practice of Pharmacy
Pharmacy
Pharmacy is the health profession that links the health sciences with the chemical sciences and it is charged with ensuring the safe and effective use of pharmaceutical drugs...
and the Manufacture and Trade in drug
Drug
A drug, broadly speaking, is any substance that, when absorbed into the body of a living organism, alters normal bodily function. There is no single, precise definition, as there are different meanings in drug control law, government regulations, medicine, and colloquial usage.In pharmacology, a...
s and poison
Poison
In the context of biology, poisons are substances that can cause disturbances to organisms, usually by chemical reaction or other activity on the molecular scale, when a sufficient quantity is absorbed by an organism....
s.
Mandate
The Pharmacy and Poisons Act, Cap 244 is an Act of ParliamentAct of Parliament
An Act of Parliament is a statute enacted as primary legislation by a national or sub-national parliament. In the Republic of Ireland the term Act of the Oireachtas is used, and in the United States the term Act of Congress is used.In Commonwealth countries, the term is used both in a narrow...
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, 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
University of Nairobi
The University of Nairobi is the largest university in Kenya. Although its history as an educational institution goes back to 1956, it did not become an independent university until 1970 when the University of East Africa was split into three independent universities: Makerere University in...
.
(f) A Pharmaceutical Technologist.
Services
The Board offers the following services:1. Product Evaluation and Registration
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
Postmarketing surveillance
Postmarketing surveillance is the practice of monitoring the safety of a pharmaceutical drug or device after it has been released on the market and is an important part of the science of pharmacovigilance...
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:v To advice the Minister of Health on all matters relating to administration and implementation of the law.
v To ensure that all medicinal product
Medicinal product
A medicinal product is defined in the European Union as any substance or combination of substances presented for treating or preventing disease in human beings...
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 and other requirements.
v To ensure continued conformity of medicinal products with set standards until their delivery to the end user.
v To ensure that medicinal products are imported, manufactured, export
Export
The term export is derived from the conceptual meaning as to ship the goods and services out of the port of a country. The seller of such goods and services is referred to as an "exporter" who is based in the country of export whereas the overseas based buyer is referred to as an "importer"...
ed, stocked, sold, distributed or otherwise dealt with by duly authorized persons.
v To grant after due assessment, licences/authorizations for medicinal products, whether locally manufactured or imported and whether destined for the national market or export.
v To revoke the registration/authorization of, or cause to be recalled from the market
Product recall
A product recall is a request to return to the maker a batch or an entire production run of a product, usually due to the discovery of safety issues. The recall is an effort to limit liability for corporate negligence and to improve or avoid damage to publicity...
, such medicinal products and the continued use of which may be detrimental to public health
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" . It is concerned with threats to health based on population health...
.
v To maintain an inventory
Inventory
Inventory means a list compiled for some formal purpose, such as the details of an estate going to probate, or the contents of a house let furnished. This remains the prime meaning in British English...
of registered medicinal products.
v To publish lists of registered medicinal products and of products with marketing authorization
Marketing authorization
Process of reviewing and assessing the dossier to support a medicinal product in view of its marketing , obviously finalized by granting of a document also called marketing authorization...
s from time to time for public information.
v To ensure that registration dossiers for medicinal products are kept up to date by the applicants and to approve alternations/changes thereto.
v To inspect and license/authorize all manufacturing
Manufacturing
Manufacturing is the use of machines, tools and labor to produce goods for use or sale. The term may refer to a range of human activity, from handicraft to high tech, but is most commonly applied to industrial production, in which raw materials are transformed into finished goods on a large scale...
premises, importing agents, wholesalers, distributor
Distributor
A distributor is a device in the ignition system of an internal combustion engine that routes high voltage from the ignition coil to the spark plugs in the correct firing order. The first reliable battery operated ignition was developed by Dayton Engineering Laboratories Co. and introduced in the...
s, hospital
Hospital
A hospital is a health care institution providing patient treatment by specialized staff and equipment. Hospitals often, but not always, provide for inpatient care or longer-term patient stays....
s, dispensaries
Dispensary
A dispensary is an office in a school, hospital or other organization that dispenses medications and medical supplies. In a traditional dispensary set-up a pharmacist dispenses medication as per prescription or order form....
, pharmacies and retail outlets.
v 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
v To monitor the market for the presence of illegal/counterfeit medicinal products.
v To ensure that the promotion and marketing of medicinal products is in accordance with product information as approved by the Board.
v To disseminate information on medicinal products to the Professions in order to promote their rational use.
v To monitor and review the implementation of the legislation
Legislation
Legislation is law which has been promulgated by a legislature or other governing body, or the process of making it...
on pharmaceutical products.
v To advise the Minister on matters concerning control and registration of medicinal products.
v To amend the rules and regulations as deemed necessary to keep pace with time demand(s).
v To register pharmacist
Pharmacist
Pharmacists are allied health professionals who practice in pharmacy, the field of health sciences focusing on safe and effective medication use...
s after due assessment and maintain the list of registered pharmacists.
v To enroll pharmaceutical technologists after due assessment and maintain the roll of enrolled pharmaceutical technologists.
v 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, 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.