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This document is intended to provide guidance on the implementation of renewals for medicine registration. This will be a “living document” and will be updated as required. Download: Annexure 1: Renewals Process Flow Diagram...
This guideline is intended to provide recommendations to applicants wishing to submit clinical applications for the registration of veterinary medicines containing specified substances. In addition to this guideline, SAHPRA reserves the right to request any additional information to establish the quality, safety, and efficacy of...
This guideline is intended to provide recommendations to applicants wishing to submit applications for the registration of veterinary medicines. ...
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...