The Minister of Health has, in terms of section 22A(2) of the Medicines and Related Substances Act, 1965 (Act 101 of 1965), on the recommendation of the South African Health Products Regulatory Authority (SAHPRA), made and updated the Schedules in the Schedule....
This document is intended to provide guidance to applicants on the scheduling of substances submitted for registration as medicines. It represents the South African Health Products Regulatory Authority’s current thinking on the safety, quality and efficacy of medicines and takes into account the country’s obligations...
This document provides guidance on the process for amending the Schedules to the Medicines and Related Substances Act, 1965 (Act 101 of 1965) to allow prescription rights to authorised health professionals, other than medical practitioners or dentists, in accordance with the provisions of section 22A...
This guideline is intended to provide guidance to applicants on the scheduling of substances submitted for registration as medicines. It represents the South African Health Products Regulatory Authority’s current thinking on the safety, quality and efficacy of medicines and takes into account the country’s obligations...
This document provides guidance to applicants regarding the acceptability of proposed proprietary names of products submitted for registration as medicines. It represents the current thinking of the South African Health Products Regulatory Authority [SAHPRA] on naming policy, how naming policy is intended to inform treatment...