Archive
25 Jul Guideline on application for use of unregistered veterinary medicines
Posted at 13:23h
in
This document provides guidance on access to unregistered medicines for animal 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...
01 Feb Clinical Trial Application Form – Guidance in conditions of a Public Health Emergency
Posted at 14:35h
in
Application to conduct a clinical trial with limited information....
01 Feb Section 21 Authorisation of Sale Unregistered Medical Devices
Posted at 11:08h
in
2017 Nov...
25 Jan Guideline For Section 21 Access To Unregistered Medicines
Posted at 13:20h
in
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...
25 Jan Section 21 Access to Unregistered Medicines – IVERMECTIN CONTROLLED COMPASSIONATE USE PROGRAMME
Posted at 13:18h
in
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.
Archive
Ivermectin Controlled Compassionate Use ProgrammeDate uploaded
...25 Jan Availability of medicines for use in a Public Health Emergency (PHE)
Posted at 10:24h
in
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)...