SAHPRA will be embarking on a survey to determine the latest annual company turnover of licence holders to understand the impact of inspection fees on the licence holders within local industry....
Applicants who are in possession of a Licence to Cultivate Cannabis for Purposes of Producing Scheduled Substances in terms of section 22C(1)(b) of the Medicines and Related Substances Act, 1965 (Act 101 of 1965) may apply for a GMP certificate for their facility. ...
This guideline provides recommendations for applicants seeking to submit an application for a licence to manufacture, import, or export a medicine or scheduled substance. It is not intended as an exclusive approach and should not be taken as a complete or authoritative statement of the...
This document has been prepared as a guide to assist applicants to comply with the requirements for Site Master Files with regard to all sites for pharmaceutical business....
This document has been prepared to serve as a recommendation to applicants wishing to conduct business as medicine wholesalers....
This document guides the requirements for Good Manufacturing Practice (GMP) in South Africa. This guideline is not intended as an exclusive approach. The South African Health Products Regulatory Authority (SAHPRA) reserves the right to request any additional information to establish the safety, quality, and efficacy...
