Guideline For Section 21 Access To Unregistered Medicines

This document provides guidance on access to unregistered medicine for human use through the provisions of section 21 of the Medicines and Related Substances Act, 1965 (Act 101 of 1965), and clarifies the mandate, intent and scope of this section and regulation 29 of the General Regulations published in terms of the Act. It outlines the process to be followed when requesting a medicine through Section 21, as well as the information required to comply with the provisions of the Act and Regulations.

The South African Health Products Regulatory Authority (the Authority) reserves the right to request any additional information to establish the safety, quality and efficacy of a medicine and may make amendments to this document in keeping with knowledge which is current at the time of consideration of the data accompanying applications for access to and use of unregistered medicines. Alternative approaches may be used but these must be scientifically and technically justifiable.

The Authority is committed to ensuring that all medicines granted approval will be of the required safety, quality, and efficacy.