Guideline to the scheduling of substances and medicines

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 in terms of international agreements. It is not intended as an exclusive approach. The Authority reserves the right to request any additional information to establish the scheduling status of a medicine in keeping with the knowledge current at the time of evaluation. Alternative approaches may be used but these should be scientifically and technically justified. It is important that applicants adhere to the administrative requirements to avoid delays in the processing and evaluation of applications.