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...
Payment of Retention Fees for the Year Ending 31 December 2022 in respect of Medicines Registered up and until 31 December 2021 and/or Various Licences...
This information manual ("the Manual") is published in terms of Section 14 of the Promotion of Access to Information Act No. 2 of 2000 ("the Act)
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