This document provides guidance on access to unregistered medicines for animal 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...
This document has been archived....
This document is intended to provide guidance on implementation of renewals for medicine registration. This will be a “living document” and will be updated as required....
This document sets out the proposed approach that SAHPRA undertakes to implement the process of medicine registration renewals ensuring a consistent approach to benefit all stakeholders to ensure quality, efficacious and safe products are available to the public....
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 to applicants wishing to submit applications for the variation of human and veterinary medicines. In addition to this guideline, SAHPRA reserves the right to request any additional information to establish the safety, quality and efficacy of a medicine in keeping with...