This document is intended to provide guidance to stakeholders on the use of the newly implemented QOS and QIS....
This document provides an overview of the safety regulatory decisions taken by SAHPRA during July - December 2022....
Please note that SAHPRA will continue to communicate registration certificates for both new medicines and relevant type || variation applications via e-mail to applicants until further notice....
The South African Health Products Regulatory Authority (SAHPRA) hereby advises applicants to verify SAHPRA banking details and the published fee Gazette before processing payments, even when a proforma invoice has been received on a SAHPRA letterhead....
As you are aware SAHPRA has embarked on a process to digitalise its business processes. We have recently concluded a pilot application process with Lot Release Testing Requests through the SAHPRA Service Desk and would like to kick off a process for taking in our...
It has come to the attention of SAHPRA that dental x-ray equipment can easily be purchased online by unlicensed retailers and are being imported to South Africa without any authorisation....
This document sets out the proposed approach that SAHPRA undertakes to implement the process of health product registration renewals, ensuring a consistent approach to benefit all stakeholders, thereby guaranteeing quality, efficacious and safe products are available to the public. This will be a “living document”...
Kindly be advised that applicants may track the progress of their new veterinary medicine registration applications on the SAHPRA website....
The purpose of this document is to provide feedback from the pilot of the administrative screening of all certification variation applications....
The document is a guide for the applicant to submit Expressions of Interest (EOIs) for evaluation of applications using the WHO pre-qualification collaborative registration process....