Regulatory Information Management System – Cancellation of Health Product Registrations for non-eCTDs

This communication aims to provide an update to applicants regarding a South African Health Products Regulatory Authority (SAHPRA)-initiated grace period for cancelling the registration of health products not in eCTD format.

Post the implementation of the eCTD 3.1 submissions process, SAHPRA has started to receive communication from applicants seeking to cancel the registration of products that are either not marketed or are being discontinued. These requests highlight that the dossiers that are not in eCTD format cannot be cancelled in accordance with ZA-SAHPRA eCTD Specifications v3.1.