This document is for use of all products including Biologics and veterinary products....
This template has been updated to conform to the new SAHPRA document format....
The template of Standardised Content for Letters of Access is populated by the applicant to authorise SAHPRA to review the APIMF record for new registration applications or variations....
Residues Overall Summary (ROS) should be completed for pharmaceutical products intended for food producing species....
This template is intended to provide recommendations to applicants wishing to submit veterinary clinical trial applications. The template should be completed in conjunction with the attached guideline document. ...
This template has been updated to conform to the new SAHPRA document format....
The Summary of Critical Regulatory Elements (SCoRE), is required for all new registration and variation applications, to facilitate evaluation by SAHPRA, and should be submitted with applications at the time of submission....
This document has been archived....