Comprehensive guideline on How to Apply for a Licence to Act as a Wholesaler (namely Private, Government Depots and Bond Stores) of medicines and scheduled substances. The guide was updated recently so that all the information required by the Authority when applying for a...
This document is intended to provide guidance on the implementation of renewals for medicine registration. This will be a “living document” and will be updated as required. Download: Annexure 1: Renewals Process Flow Diagram...
This document is intended to provide communication to industry on nitrosamine review for all other new, in-process and registered products including biological medicines and all old medicines. This will be a “living document” and will be updated. It is important that Applicants adhere to the...
To develop a medicine information data bank on the quality of medicines in circulation and disseminate such information to stakeholders involved in the medicines supply chain. To promote communication and cooperation between stakeholders and partners involved in the medicines supply chain. To identify possible causes of inferior...
This document has been prepared to serve as a guidance document regarding SAHPRA requirements for release of import health products at Ports of Entry - Regulatory Compliance Unit....
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 provides an overview of the safety regulatory decisions taken by SAHPRA on the safety concerns discussed during January – March 2022. This includes a summary of regulatory decisions, where safety concerns were reviewed and concluded, and those safety concerns that are not concluded...
This guideline is intended to assist Applicants/ HCRs in the reporting of ADRs/AEFIs associated with the use of health products, as provided for in the scope, and in the management of safety data which may arise during post-registration, including during Phase 4 post-marketing clinical trials....