Post Clinical Trial Access

This document has been prepared to serve as a guideline to sponsors/applicant and investigators providing investigational pro duct to participants during clinical trials. This is to ensure that p with the product as per conditions of this guideline. articipants who derive benefit from the investigational products will be provided This guideline represents the (SAHPRA) current thinking on the mea South African Health Products Regulatory Authority ’s sures to be taken to ensure that patients gain access to their treatment independently once the trial is over. It is not intended as an exclusive approach. SAHPRA make amendments in keeping with current knowledge. published for comment reserves the right to request any additional information and may