LOC Other changes ASK - Table 5: Sponsor changes table Code Sponsor change Status Assurances/ Legislative basis Documentation SSP Sponsor name/logo/ sponsor N 2, L 9D(3) address (same sponsor of goods) and/or change to manufacturer/supplier details on label Table 6: Product details changes table Code Product detail change Status Assurances/ Legislative basis Documentation PSZ Pack size other than N 2, 3, 7, L, P 9D(3) – (see PLS) or metered dose aerosols (see PMZ) (see also KBT, KGL, KBL and KOT) PLS Pack size liquids/semi-solids N 2, 3, 7, 10, L, P 9D(3) – PMZ Pack size metered dose aerosols A - 9D(3) – PVI Visual identification (note that N 2, 10, 16 9D(3) novelty shapes, e.g. animal-shaped tablets, are not acceptable) PSL Shelf life increase (other than in A - 9D(3) – change PSP) PSR Shelf life decrease N 2 9D(3) – PSP Shelf life increase (in accordance N 2, 8, 17 9D(3) – with an approved stability testing protocol for that product) PPR Approval of a stability testing A - 9D(3) protocol for a specific product
LOC Other changes ASK - Table 5: Sponsor changes table Code Sponsor change Status Assurances/ Documentation Legislative basis SSP Sponsor name/logo/ sponsor address (same sponsor of goods) and/or change to manufacturer/supplier details on label N 2, L 9D(3) Table 6: Product details changes table Code Product detail change Status Assurances/ Documentation Legislative basis PSZ Pack size – other than (see PLS) or metered dose aerosols (see PMZ) (see also KBT, KGL, KBL and KOT) N 2, 3, 7, L, P 9D(3) PLS Pack size – liquids/semi-solids N 2, 3, 7, 10, L, P 9D(3) PMZ Pack size – metered dose aerosols A - 9D(3) PVI Visual identification (note that novelty shapes, e.g. animal-shaped tablets, are not acceptable) N 2, 10, 16 9D(3) PSL Shelf life – increase (other than in change PSP) A - 9D(3) PSR Shelf life – decrease N 2 9D(3) PSP Shelf life – increase (in accordance with an approved stability testing protocol for that product) N 2, 8, 17 9D(3) PPR Approval of a stability testing protocol for a specific product A - 9D(3)