This guideline is intended to provide recommendations to applicants wishing to submit applications for the registration of Human Medicines containing specified substances. In addition to this guideline, SAHPRA reserves the right to request any additional information to establish the safety, quality, and efficacy of a...
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...
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...
2020 Sep...
This guideline document is intended to provide recommendations to applicants wishing to submit amendments for registered biological medicines. It represents the South African Health Products Regulatory Authority’s (SAHPRA) current thinking on ensuring the safety, quality and therapeutic efficacy of medicines. It is not intended as...
This guideline is intended to give guidance to applicants regarding the type of stability that should be provided in support of the shelf-life of the biological medicines. It represents SAHPRA current thinking on the safety, quality and efficacy of the biological medicines. This guideline is...
This document provides guidance on the procedures involved in the scheduling and conduct of Pre-Registration Consultation meetings between the Office of the Chief Regulatory Authority (CRO) of the South African Health Product Regulatory Authority (SAHPRA), and the applicant / sponsor for biological medicines. The primary...
This document provides guidance on the process for amending the Schedules to the Medicines and Related Substances Act, 1965 (Act 101 of 1965) to allow prescription rights to authorised health professionals, other than medical practitioners or dentists, in accordance with the provisions of section 22A...
This guideline is intended to provide guidance to applicants on the scheduling of substances submitted for registration as medicines. It represents the South African Health Products Regulatory Authority’s current thinking on the safety, quality and efficacy of medicines and takes into account the country’s obligations...