This document intends to provide clarity on SAHPRA’s Core Business Escalation procedure, to enable effective and efficient communication between SAHPRA and its stakeholders....
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). Applicants are required to comply with the provisions of the Act and Regulations....
Request For Use of An Unregistered Product In Terms of Section 21 of Act 101 of 1965...
Request For Use of an Unregistered Product In Terms Of Section 21 Of Act 101 of 1965...
This document guides 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 General Regulations...
2017 Nov...
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 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)...