Guidelines for Recall and Withdrawal of Medical Products and Health Technologies

Post-marketing quality surveillance of medical products and health technologies is a critical function of the PPB and it is useful in monitoring and assuring quality of products circulating in the Kenyan market. Recalls and withdrawal of medical products based on the health risk that may occur to the population is one of the regulatory actions that are implemented following market surveillance activities.

Recalls are effective methods for removing or correcting marketed products, their labeling and / or promotional literature that violate the requirements administered by the Pharmacy and Poisons Board. Recalls enable the Board to protect safety and health of the public and prevent health risks that may be presented from substandard and falsified medical products or safety issues. It is an efficient and timely method especially when products are widely distributed.

The Market Authorization Holders and importers regulated by the Board may initiate recalls in consultation with the Board to fulfill their responsibility to protect public health and safety. The entities may also initiate recalls following notification of quality defect or safety issue from the Board, and in response to a formal requirement from the Board, as statutory recall.

The guidelines are made for information and guidance by all concerned players and stakeholders.