This document is intended to provide requirements to applicants wishing to submit applications for the registration of medicines in eCTD format. It reflects the current situation and will be regularly updated with changes in legislation and experience gained....
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...
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...