This is the primary application form for applicants to use for the purpose of amending an already approved study protocol....
Due to the rapidly changing dynamics of the condition/disease, it has become necessary for the South African Health Products Regulatory Authority (SAHPRA) to introduce a two-weekly public health emergency (PHE) Abridged Interim Safety and Futility Monitoring Report Form for clinical trials. ...
Application to conduct a clinical trial with limited information....
This document is intended to be used for new clinical trials applications...
This is the primary application form for applicants to use in case of an application for Phase IV applications....
This document has been archived....
This document has been archived....
This document has been archived....
An application form for the purpose of obtaining a licence by a licensed wholesaler to export medicinal products (i.e. medicines and scheduled substances) in terms of the provisions of the Medicines and Related Substances Act, 101 of 1965, Section 22C and 22D read together with...
An application form for the purpose of obtaining a licence or renewing/amending a licence in terms of the provisions of the Medicines and Related Substance Act, 1965 Section 22C and 22D read together with Regulation 23 and 24 of the General Regulations to the Medicines...