This document has been prepared to serve as a guidance document regarding SAHPRA requirements for advertisement of medicines and health products- Regulatory Compliance Unit....
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's current thinking on the safety, quality, and efficacy of medicines. SAHPRA reserves the right to request any additional...
This document serves as a guideline to Applicants/ holders of certificates of registration (HCRs) on the reporting of adverse drug reactions/ events. It represents the South African Health Products Regulatory Authority’s current thinking on the safety, quality, and efficacy of medicines. The Authority reserves the right...
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 avoid...
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...
This guideline is intended to provide guidance to applicants wishing to submit an appeal against all regulatory decisions that are administrative in nature. Any person aggrieved by the decision of the Authority may appeal against such decision by notifying the Chief Executive Officer within thirty (30)...
This guideline is intended to provide guidance to applicants wishing to submit new application for registration of biological medicines. It represents the Authority’s current thinking on the safety, efficacy and quality of medicines. It is not intended as an exclusive approach. SAHPRA reserves the right...