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This document has been prepared to serve as a recommendation to those who wish to import and export medicines in South Africa. The South African Health Products Regulatory Authority (SAHPRA) is committed to ensure that all medicines entering or leaving the country will retain the...

This guideline is intended to provide recommendations to applicants wishing to submit an application for a licence to manufacture, import or export a medicine or scheduled substances. It is not intended as an exclusive approach and should not be taken as a complete or authoritative...

The objective of this procedure is to define the process to be followed and to provide instruction to the Holder of the Certificate of Registration (HCR) when submitting an application for Post-Importation Testing Exemption or imported products.

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This document provides guidance on access to unregistered medicine for human use through the provisions of section 21 of the Medicines and Related Substances Act, 1965 (Act 101 of 1965), and clarifies the mandate, intent and scope of this section and regulation 29 of the...