Guidelines for Scheduling of Health Products and Technologies

Pharmacy and Poisons Board (PPB) is the National Medicines Regulatory Authority (NMRA) for Kenya mandated to regulate Practice of Pharmacy Profession, health Products and Technologies. The Board seeks to ensure, quality, safety and efficacy of health products and technologies available in the Kenya Market. Additionally, the Board aims to ensure that information passed to medical professionals and the general public by marketing authorization holders (MAHs) is accurate and factual so as to avoid misinformation geared towards promotion of certain products or to gain advantage over other products.

Scheduling is a national classification system that controls how health products and technologies are made available to the public. One of the key functions of the Board is scheduling and rescheduling of Health products and Technologies according to the level of regulatory control required, need for their availability and the protection of public health.

The key considerations that shall guide scheduling and rescheduling include; risk to harm, accessibility, therapeutic index, abuse potential, inappropriate use, precaution, community harm, precedence, efficacy, availability of medicines with similar active ingredient, legal control, manufacturing, labelling, pack sizes, dosage forms, items in the essential medicines list and Levels of prescribing.