Archive

To develop a medicine information data bank on quality of medicines in circulation and disseminate such information to stakeholders involved in medicines supply chain. To promote communication and cooperation between stakeholders and partners involved in medicines supply chain. To identify possible causes of inferior quality of specific...

This guideline intends to assist applicants in differentiating between various types of permits, the requirements for each permit and the relevant fees applicable. This guideline is applicable to Section 22A permits and related authorizations in Regulatory Compliance. The scope includes the application process, fee applicable and...

This document has been prepared to serve as a recommendation to applicants regarding the recalls and withdrawal of medicines, and the South African Health Products Regulatory Authority current thinking on the safety, quality and efficacy of medicines. SAHPRA reserves the right to request for any...

Version 3

This document is intended to provide guidance to applicants for lot release requirements for all human vaccines. This will be a “living document” and will be updated on a regular basis. It is important that applicants adhere to the prescribed requirements in order to...

This document is intended to provide guidance to applicants on the scheduling of substances submitted for registration as medicines. It represents the South African Health Products Regulatory Authority’s current thinking on the safety, quality and efficacy of medicines and takes into account the country’s obligations...

This document provides guidance to the applicants/holders of Certificate of Registration on the pharmacovigilance system requirements. It is meant to facilitate compliance by applicants/HCRs with the regulatory authority on pharmacovigilance requirements....

This document has been prepared to serve as a guideline to those involved in the conduct of Pharmacovigilance inspections. It is meant to facilitate compliance with Good Pharmacovigilance Practice relating to the conduct and monitoring of Pharmacovigilance inspections. It is not intended as an exclusive...