A Comparison of Variation Filling Approaches in South Africa and Botswana’s Legal Framework

Abstract

Variations are unavoidable changes brought about by a variety of factors, such as evolving demands, modifications to product formulation, changes in the manufacturing process, and adjustments to standards for active ingredients or final goods. Consequently, regardless of whether a change is for a commercial or experimental product, regulations mandate that it be thoroughly considered and implemented via the appropriate regulatory pathway. Product variation adjustments that are not compliant with regulations may result in the product being labelled as misbranded or adulterated. For marketed medications, this needs to be treated very seriously due to the possible influence on safety and efficacy for a large number of patients, as well as the potential legal, regulatory, and business ramifications for the sponsor. The aim of this research is to provide a brief summary of the modifications made to the variation policies by the European Medicines Agency (EMA), The South African Health Products Regulatory Authority (SAHPRA) and the Botswana’s Medicines Regulatory Authority (BOMRA). The report also provides information on the costs associated with filing variations in South Africa and Botswana and the portal specifications for submitting variations.