Availability of medicines for use in a Public Health Emergency (PHE)

This guideline provides recommendations to applicants who intend to submit applications for the registration or authorisation of medicines intended to be available to those affected by a public health emergency. It represents the current thinking of the South African Health Products Regulatory Authority (the Authority) on approaches to determine the quality, safety, and efficacy of the medicines required in a public health emergency, and is not intended as an exclusive approach. The Authority reserves the right to request any additional information to establish the safety, quality and efficacy 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. The Authority is committed to ensuring that all registered or authorised medicines are of the required safety, quality and efficacy. It is important that applicants also adhere to administrative requirements to avoid delays in the processing and evaluation
of applications.

This document should be read in conjunction with all other related guidelines and templates, available from the Authority’s website: www.sahpra.org.za.