New Chemical Entity New Generic (Multi-source) New Complementary New Biological New Biosimilar New Clinical Trial Application New Vaccines New VAMF New SMF New APIMF New PMF Line extension - New Strength Line extension - New Dosage Form Line extension - New Application (De-Linking of Application) Clone Replica - Same Type IA - Quality Type IA - Clinical Type IA - Inspectorate Type IAin - Inspectorate Type IAin - Clinical Type IAin - Quality Type IB - Clinical Type IB - Quality Type IB - Inspectorate Grouped Variation Clinical Grouped Variation Quality Grouped Variation Inspectorate Type II - Safety (Clinical) Type II - Safety and Efficacy (Clinical) Type II-Related Clinical Type II-Related Quality Type II - Inspectorate Type II - Grouped Variation N&S Type II - Quality Type II - Rescheduling Type II - Proprietary Name Change Type II - Change in Applicant-Relinquishing Type II - Change in Applicant-Acquiring Baseline z-Code - Type IAin z-Code - Type IA z-Code - Type IB z-Code - Type II Pharmacovigilance USRN - Clinical & Pharmacovigilance Application Withdrawal/Cancellation Renewal Only use if advised by SAHPRA to use Description updated to include (De-Linking of Application) Description updated from Type I-Inspectorate to Type IA - Inspectorate Description updated from Type I-Other to Type IAin - Inspectorate Description updated from Type IB-Related Clinical to Grouped Variation Clinical Description updated from Type IB-Related Quality to Grouped Variation Quality Description updated from Type IB-Related Inspectorate to Grouped Variation Inspectorate Description updated from Type II-Related Inspectorate to Type II - Inspectorate Description updated from z-Code-Quality to z-code - Type II