This application form should be included in the South African Common Technical Document – Module 1 Administrative Information. The application form is to be used for an application for registration, variation or renewal of a medicinal product for Human or Veterinary use submitted to the South...
The application form shall be used for an application for lot release of a human vaccine submitted to the South African Health Products Regulatory Authority....
This is a form to report ADRs in clinical trials....
This is the primary application form for applicants to use in case of an application for additional investigators or change of investigator(s)/sites and application for additional sites....
This is the primary application form for applicants to use for the purpose of amending an already approved study protocol....
Application to conduct a clinical trial with limited information....
This document is intended to be used for new clinical trials applications...