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01 Feb

Posted at 10:18h in

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....

01 Feb

Posted at 10:09h in

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 a variation application for a medicinal product for human use submitted in eCTD format. It is also used for follow-up...