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The Medicines and Related Substances Act No. 101 of 1965 as amended makes provisions for the payment of retention fees to the South African Health Products Regulatory Authority (SAHPRA) in respect of medicines registered, medical devices, including in vitro diagnostics (IVDs), establishment licences issued. These...

This guideline is intended to provide recommendations to applicants wishing to submit applications for the registration of Human Medicines (categories A and D) containing specified substances. With respect to Category D medicines, the guidance provided herein is related to general content requirements. Any specific technical...

This guideline is intended to provide recommendations to applicants wishing to submit applications for the registration of Human Medicines (categories A and D) containing specified substances. With respect to Category D medicines, the guidance provided herein is related to general content requirements. Any specific technical...