The Validation Template is used on receipt of an application to verify that all required information has been supplied to SAHPRA in order to evaluate an application for the renewal of registration of a medicinal product for human or veterinary use submitted in eCTD format....
This document is for use of all products including Biologics and veterinary products, where the information is not applicable for the specific molecule; indicate "N/A". Veterinary medicine applicants are advised to also refer to the VICH guidelines....
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....
Letter of access for SAHPRA, in reference to APIMF record [APIMF number, if allocated]...
Residues Overall Summary (ROS) should be completed for pharmaceutical products intended for food producing species....
This document has been archived....
This template has been updated to conform to the new SAHPRA document format....