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25 Jan

Posted at 10:04h in

This document provides recommendations for applicants submitting variation applications for human and veterinary medicines. In addition to this guideline, the South African Health Products Regulatory Authority (SAHPRA) reserves the right to request additional information to establish the safety, quality and efficacy of a medicine based...

25 Jan

Posted at 10:01h in

This guideline is intended to provide recommendations to applicants wishing to submit applications for the registration of medicines. It represents the South African Health Products Regulatory Authority’s (SAHPRA) current thinking on the safety, quality and efficacy of medicines. It is not intended as an exclusive...