Archive
25 May Application for rescheduling of a substance or medicine
Posted at 14:12h
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This document 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...
24 Jan Scheduling of substances for prescribing by authorised prescribers other than medical practitioners or dentists
Posted at 12:46h
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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...
24 Jan Guideline to the scheduling of substances and medicines
Posted at 12:44h
in
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...
24 Jan Guideline for proprietary names for medicines
Posted at 12:39h
in
This document provides guidance to applicants regarding the acceptability of proposed proprietary names of products submitted for registration as medicines. It represents the current thinking of the South African Health Products Regulatory Authority [SAHPRA] on naming policy, how naming policy is intended to inform treatment...