PRIMS Manual

The Pharmacy and Poisons Board (PPB) has been involved in numerous ventures towards the improvement in the delivery of health services in Kenya and the maintenance of quality standards for training and practice of pharmacists and pharmaceutical technologists in Kenya. To this regard, PPB has reviewed its internal processes and policies in line with the provision of online Services and has opened up its services to students, training institutions, practitioners, retail and wholesalers as well as the public at large.

The Pharmacy and Poisons Board (PPB) is the Drug Regulatory Authority established under the Pharmacy and Poisons Act, Chapter 244 of the Laws of Kenya. The Board regulates the Practice of Pharmacy and the Manufacture and Trade in drugs and poisons. The Board aims to implement the appropriate regulatory measures to achieve the highest standards of safety, efficacy and quality for all drugs, chemical substances and medical devices, locally manufactured, imported, exported, distributed, sold, or used, to ensure the protection of the consumer as envisaged by the laws regulating drugs in force in Kenya.

Pharmacy and Poisons Board has implemented Pharmaceutical Regulatory Information Management System (PRIMS), to support in management of data and information collected and processed by Board. PRIMS handles all the regulatory functions of the board which is mandated with Pharmacy regulation, a obligation that is undertaken under four key functions as follows:

1. Pharmacy Profession Development and Practice Regulation
2. Pharmaceutical Products Regulation
3. Pharmacy Trade Facilitation
4. Enforcement

This document covers the following modules:

A. PRACTICE REGULATION

a. Professional Capacity development and monitoring

1. Application for Indexing
2. Application to sit for Professional Examinations
3. Application for Internship Placement/exemption
4. Application for Admission to Practice
5. Confirmation of CPD points/Exam Results

2. Training Institutions, Programmes and Examinations regulation
   1. Application for Registration of Training Institutions
   2. Application for accreditation of Training Programmes
   3. CPD/Training programmes scheduling
   4. Appointment of Examiners
   5. Administration of Professional Examinations
3. Practice Regulation

i. Application for a Practice License

B. PRODUCT REGULATION

a. Product Licensing and Certification
i. Application for Certificate of Pharmaceutical product

C. PHARMACY TRADE FACILITATION

a. Business Licensing
i. Application for a Pharmaceutical Business License

b. Import/Export Facilitation

1. Application for Permit to Import/Export pharmacy products
2. Import/Export inspection and Verification