11.12 Changes Tables Label change (including package insert) Status A/D* GPN Proprietary name (if grouping applies) A 1, 2, L PIN Proprietary name (if grouping does not apply) NEW - GIN New therapeutic indications (if grouping applies) A 1, 3, L PTI New therapeutic indications (if grouping does not apply) NEW - LIW Therapeutic indications or directions for use change of A 4, L – wording without altering meaning LIS Therapeutic indications removal of subset of indications from N 5, L – LIR Therapeutic indications addition of Registered indications to A 5, L – label GDU Directions for use e.g. dosage instructions (if grouping A 1, 3, L – applies) (See also LIW) LDU Directions for use (if grouping does not apply) NEW - PSC Recommended storage conditions more restrictive N 5 – PST Recommended storage conditions less restrictive A - – LSR Addition of more restrictive safety-related statements N 5, L LSF Changes on label (signal headings, warning statements) in A - compliance with new SUSMP requirements, where the change in scheduling is from S4 to a lower schedule Changes on label (signal headings, warning statements) in N 5, 8, L LSU compliance with new SUSMP requirements, other than LSF LLO Changes to bring a label into compliance with the Labelling N 5, 7, L Order other than changes to the proprietary name, indications – or directions for use LLR Addition of a required representation to a label (Schedule 2 to N 5, 7, L the Therapeutic Goods Regulations) LCF Colour, font, type size only (no change in label copy) N 5, L
11.12 Changes Tables Label change (including package insert) Status A/D* GPN Proprietary name (if grouping applies) A 1, 2, L PIN Proprietary name (if grouping does not apply) NEW - GIN New therapeutic indications (if grouping applies) A 1, 3, L PTI New therapeutic indications (if grouping does not apply) NEW - LIW Therapeutic indications or directions for use – change of wording without altering meaning A 4, L LIS Therapeutic indications – removal of subset of indications from N 5, L LIR Therapeutic indications – addition of Registered indications to label A 5, L GDU Directions for use – e.g. dosage instructions (if grouping applies) (See also LIW) A 1, 3, L LDU Directions for use (if grouping does not apply) NEW - PSC Recommended storage conditions – more restrictive N 5 PST Recommended storage conditions – less restrictive A - LSR Addition of more restrictive safety-related statements N 5, L LSF Changes on label (signal headings, warning statements) in compliance with new SUSMP requirements, where the change in scheduling is from S4 to a lower schedule A - LSU Changes on label (signal headings, warning statements) in compliance with new SUSMP requirements, other than LSF N 5, 8, L LLO Changes to bring a label into compliance with the Labelling Order – other than changes to the proprietary name, indications or directions for use N 5, 7, L LLR Addition of a required representation to a label (Schedule 2 to the Therapeutic Goods Regulations) N 5, 7, L LCF Colour, font, type size only (no change in label copy) N 5, L
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