The off-label use of medication in South Africa: What about some information for medical practitioners?

Abstract

The Medicines and Related Substances Act (the Act) provides for the registration of medicine by the Medicines Control Council (MCC). In terms of the Medicines and Related Substances Amendment Bill, signed but not yet proclaimed, the MCC will shortly be replaced by the South African Health Products Regulatory Authority (SAPHRA). Despite major changes in the administrative structure, SAPHRA will probably have the same functions as the MCC. Section 14 of the Act forbids the sale of unregistered medicine.