Licensing Establishments & Pharmacy Practice
Premises / Establishments
The Pharmacy and Poisons Board is committed to its mission to ensure the availability of pharmaceutical services in Kenya which satisfy the needs of all for the prevention, diagnosis and treatment of diseases using safe, efficacious, high quality and cost effective pharmaceutical products.
Pursuant to this mission, it is imperative that pharmaceuticals are distributed by highly qualified personnel through outlets that are duly licensed and professionally run. The operations in those premises should at all times be supervised by qualified personnel and the risk of exposing the public to unsafe medicines avoided at all cost. Guidelines have been prepared to provide persons in the pharmaceutical fraternity with a method of assessing eligibility and the process of lawfully operating drug distribution outlets.
The success of this initiative will ultimately depend on the active contribution and cooperation of every stakeholder. Registered Practitioners and Premises.
Wholesale distribution and retail forms part of the supply chain of manufactured therapeutic goods. Wholesalers are responsible for effective, efficient and safe handling, storage and distribution of such products.
Guidelines and Procedures
Regulatory Decisions
Practice Licenses and Pharmaceutical Representative Permits
It is a legal requirement under section 9A of the Pharmacy and Poisons Act, Cap 244 Laws of Kenya, hereinafter referred to as “the Act’, for every registered pharmacist or enrolled pharmaceutical technologist to obtain a practicing license which is an authorization from the Board to practice as registered pharmacists or enrolled pharmaceutical technologists respectively. A person shall be deemed to engage in the practice of pharmacy if the person:
a) engages in, conducts or carries on the dispensing, manufacture, compounding of any drugs or medicines, or offers any form of pharmaceutical care or pharmaceutical services within Kenya; or
b) advertises or represents himself or herself by a title, sign, display, declaration, or other item to be a pharmacist or pharmaceutical technologist.
The requirement for a valid practice license applies to all regardless of the place of work as refenced in section 9(C)(3) of the Act.
The Act also recognizes specialist pharmacists and the Board has developed guidelines to provide a framework for recognition of pharmacy specialties. This, coupled with implementation of continuing professional development, are efforts geared to support the attainment of Universal Health Coverage (UHC) and offering the highest achievable standards of healthcare.
Pharmaceutical Representative’s Permits may be issued to a representative of a person engaged in the sale and supply of pharmaceuticals containing a poison who may, in the course of business, give free samples of such products to persons who may lawfully possess Part I poisons, subject to the Act.
Continuing Professional Development (CPD)
Acquisition of adequate knowledge, skills, attitudes and experience is a fundamental professional and ethical requirement for developing and maintaining professional competence throughout a professional career, during which new and challenging professional responsibilities and changing healthcare situations will be encountered.
The Pharmacy and Poisons Act, Cap 244 Laws of Kenya mandates the Board in section 3(3)(k) to establish, approve and accredit continuing professional educational programs for pharmacists and pharmaceutical technologists. Section 9F of the Act requires every registered pharmacist and enrolled pharmaceutical technologist to undertake appropriate Continuing Professional Development (CPD). This is a condition for annual practice licensure under Section 9C.
To support the achievement of this competence goal, the Board has issued s a platform for management of CPD in the online licensing system. This makes it easy and convenient to search for available CPD programmes, activities and events and subsequently participate and directly accrue points in the portal.
- CPD Providers
- CPD Programs and Events
Registration and Enrollment
The Pharmacy and Poisons Board (PPB) keeps the Register of Pharmacists and the Roll of Pharmaceutical Technologists in Kenya. For a person’s name to be entered in the Register or Roll, the person must satisfy the Board that he/she holds a qualification recognized under the Pharmacy and Poisons Act and other requirements, including supervised internship or attachment, as may be prescribed under the Act. The PPB has issued guidelines on the criteria and process of registration and enrolment.
Approved Training Institutions
Globally, the roles for pharmacists in healthcare is fast evolving, putting them in a unique position to swiftly identify and respond to emerging health threats. In addition to the traditionally recognized roles and competencies, modern day challenges have increasingly presented an opportunity for pharmacists to participate actively in all aspects of primary health care service provision including immunization, reproductive health services, infection prevention, health promotion and administration of medication.
In Kenya, the Pharmacy and Poisons Act, Cap 244 Laws of Kenya mandates the Board to regulate the profession of pharmacy, including training of pharmacists and pharmaceutical technologists. Quality education is key to equipping pharmacists and pharmaceutical technologists with adequate knowledge, skills and attitudes to competently take on their role.
To support the achievement of this competence goal, the Board has developed curricula guidance for pharmacy degrees and diploma level training together with the corresponding certification framework and standards. The primary focus is the development of an adequate and appropriate pharmacy workforce, along with the academic and institutional infrastructure to deliver the required competency-based education and training. The PPB collaborates with other government agencies, institutions and stakeholders involved in regulation and quality assurance in education to ensure optimum standards for the pharmacy profession.
The list of institutions who offer approved pharmacy courses is published as a guide to the public.
Student Indexing
Indexing is the process of entering eligible persons into the Pharmacy and Poisons Board database of persons who are undertaking training at the time. It is necessary to confirm eligibility criteria for the course offered and for planning purposes thus enabling the making of medium-term projections for examinations, internship positions and future pharmacy workforce. Indexing shall be made online in the PPB Practice portal for eligible applicants. For those studying in Kenya, the process should be initiated by the training institutions through the course administrator/coordinator not more than 3 months after admission.
Student Indexing
Exams
The Pharmacy and Poisons Act, Cap 244 Laws of Kenya mandates the Board in section 3(3)(e) to prescribe and conduct examinations for purposes of recognition, registration or enrolment under the Act. These examinations are designed to assess the knowledge, skills, abilities and attitudes of pharmacists and pharmaceutical technologists to ensure that they are competent to practice safely and effectively. The examinations are offered twice a year in April/May and October/November.