07 Feb Medical Device Establishment Licence Renewal – ISO13485 Certificate Communication
This document has been archived....
This document has been archived....
This guideline is intended to provide recommendations to applicants wishing to submit clinical applications for the registration of veterinary medicines containing specified substances. In addition to this guideline, SAHPRA reserves the right to request any additional information to establish the quality, safety, and efficacy of...
This guideline is intended to provide recommendations to applicants wishing to submit applications for the registration of veterinary medicines. ...
This is a form to report ADRs in clinical trials....
This form is to be completed six-monthly from the date of approval of the clinical trial by the South African Health Products Regulatory Authority (SAHPRA). ...
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....