LFO Reformatting of pre-existing text (ie. moving of blocks of text and N 5, L not rewording see LIW, LRT) – _________________________ * A/D = assurances to be and supporting documentation required for the given status to apply. Refer to for an explanation of all codes used. Label changes (including package insert) Status A/D* LRT Rewording of pre-existing text without altering meaning (other A - than indications or directions for use see LIW) – LDT Deletion or addition of text to the label (eg. addition or removal of A - claims such as clinically proven, fast/rapid action; general claims regarding the product, its nature, mechanism of action, qualifying statements, etc) LOC Other changes Ask - Sponsor changes Status A/D* SSP Sponsor name/logo(same sponsor of goods) and/or change to N 5, L manufacturer/supplier details on label SAD Sponsor address Write to - OTC STR Transfer goods to another sponsor N 5, T, L Product detail changes Status A/D* GPN Proprietary name (if grouping applies) A 1, 2, L PIN Proprietary name (if grouping doesn’t apply) NEW - PSZ Pack size other than liquids/semi-solids (see PLS) or metered N 5, 6, 10, – dose aerosols (see PMZ) (see also KBT, KGL, KBL and KOT) L, P PLS Pack size liquids/semi-solids N 5, 6, 10, – 13, L, P PMZ Pack size metered dose aerosols A - – GIN New therapeutic indications (if grouping applies) A 1, 3, L PTI New therapeutic indications (if grouping doesn’t apply) NEW - PDF Dosage form (as defined in TGA Standard Terminology6) NEW - PVI Visual identification N 5, 13, 19 PSL Shelf life increase (other than in change PSP) A - – PSR Shelf life decrease N 5 – PSP Shelf life increase (in accordance with an approved stability N 5, 11, 20 – testing protocol for that product) PPR Approval of a stability testing protocol for a specific product A -
LFO Reformatting of pre-existing text (ie. moving of blocks of text and not rewording – see LIW, LRT) N 5, L _________________________ * A/D = assurances to be and supporting documentation required for the given status to apply. Refer to for an explanation of all codes used. Label changes (including package insert) Status A/D* LRT Rewording of pre-existing text without altering meaning (other than indications or directions for use – see LIW) A - LDT Deletion or addition of text to the label (eg. addition or removal of claims such as clinically proven, fast/rapid action; general claims regarding the product, its nature, mechanism of action, qualifying statements, etc) A - LOC Other changes Ask - Sponsor changes Status A/D* SSP Sponsor name/logo(same sponsor of goods) and/or change to manufacturer/supplier details on label N 5, L SAD Sponsor address Write to OTC - STR Transfer goods to another sponsor N 5, T, L Product detail changes Status A/D* GPN Proprietary name (if grouping applies) A 1, 2, L PIN Proprietary name (if grouping doesn’t apply) NEW - PSZ Pack size – other than liquids/semi-solids (see PLS) or metered dose aerosols (see PMZ) (see also KBT, KGL, KBL and KOT) N 5, 6, 10, L, P PLS Pack size – liquids/semi-solids N 5, 6, 10, 13, L, P PMZ Pack size – metered dose aerosols A - GIN New therapeutic indications (if grouping applies) A 1, 3, L PTI New therapeutic indications (if grouping doesn’t apply) NEW - PDF Dosage form (as defined in TGA Standard Terminology6) NEW - PVI Visual identification N 5, 13, 19 PSL Shelf life – increase (other than in change PSP) A - PSR Shelf life – decrease N 5 PSP Shelf life – increase (in accordance with an approved stability testing protocol for that product) N 5, 11, 20 PPR Approval of a stability testing protocol for a specific product A -
otc-argom-121011.docx