This document is intended to provide communication to industry on the changes of EDQM CEP and implementation of CEP 2.0 for all other new applications for orthodox medicines. This will be a “living document” and will be updated in line with changes observed from the...
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....
This document is intended to provide communication to the Medical Device Establishment Licence Industry in relation to the Appointment of Yellow Clip Financial Services....
As you are aware, SAHPRA has been focused on progressing the digital transformation of the organisation over the past few years. We have different initiatives underway to digitalise our business processes....
Kindly note that this communication serves to communicate two (2) processes that the SAHPRA Pharmacovigilance (PV) unit has revised. You are urged to take note of these revisions....
This document is intended to provide communication to applicants and holders of authorities of activities regulated by the Hazardous Substances Act, Act 15 of 1993 and amended regarding the requirements for internal rules that must be drawn up terms of Regulation 7 of the Regulations...
COVID-19 Clinical Trials - Two-Weekly Progress Reports Pilot – Clinical Trial Applications...
As you may be aware, SAHPRA has embarked on a process to digitalise its business processes. A pilot electronic process is planned for new medicinal clinical trial applications for January 2024. The official launch of the system for all new medicinal clinical trial applications will...
Please be informed that all documents and queries for GMP and CPP certificates should now be emailed to a new dedicated email address - see download. ...