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30 Mar

Posted at 11:23h in

The applicant is to ensure that all relevant fields are completed on the application form and that all supporting documentation is attached. Incomplete applications will be identified as deficient, and the evaluation review will not be progressed until deficiencies are addressed. A completed application...

25 Sep

Posted at 10:32h in

The Minister of Health has, in terms of section 22A(2) and 37A of the Medicines and Related Substances Act, 1965 (Act No. 101 of 1965), on the recommendation of the South African Health Products Regulatory Authority (SAHPRA), made and updated the Schedules....

25 May

Posted at 14:12h in

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

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

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 on the naming policy, how the naming policy is intended to inform...