This guideline provides recommendations for applicants seeking to submit an application for a licence to manufacture, import, or export a medicine or scheduled substance. It is not intended as an exclusive approach and should not be taken as a complete or authoritative statement of the...
This document has been prepared as a guidance document on the fees structure employed to calculate the fees for GxP and product related inspections....
This guideline is intended to provide guidance to the applicants responding to the inspection report following a GMP, GWP, GCP, GVP, inspection at their site....
This document has been prepared as a guide to assist applicants to comply with the requirements for Site Master Files with regard to all sites for pharmaceutical business....
This document has been prepared to serve as a recommendation to applicants wishing to conduct business as medicine wholesalers....
The objective of this procedure is to define the process to be followed and to provide instruction to the Holder of the Certificate of Registration (HCR) when submitting an application for Post-Importation Testing Exemption or imported products. ...
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...
Given that there is currently no credible evidence to support a therapeutic role for Ivermectin in COVID-19, SAHPRA has decided to terminate the Programme with immediate effect.
This guideline is intended to provide recommendations to applicants wishing to submit applications for the manufacture, importation, distribution and exportation of Class B, Class C and Class D medical devices and In Vitro diagnostics (IVDs). It represents the South African Health Products Regulatory Authority current...
This guideline is intended to provide recommendations to applicants wishing to submit applications for a licence to manufacture, import, distribute and export a medical device, including In Vitro diagnostics medical devices (IVDs). It represents the South African Health Products Regulatory Authority’s current thinking on the...