MMA TGA-licensed Australian manufacturer (includes site of N 5, 9 manufacture) MOS Overseas manufacturer (includes site of manufacture), if GMP N 5, G pre-clearance certificate provided MOP Overseas manufacturer (includes site of manufacture), if GMP A - pre-clearance not provided MPR Manufacturing process (other than MBS) N 13 MBS Batch size for pressurised inhalation (nasal and oral A - respiratory) products MMA TGA-licensed Australian manufacturer (includes site of N 5, 9 manufacture) MOS Overseas manufacturer (includes site of manufacture), if GMP N 5, G pre-clearance certificate provided MOP Overseas manufacturer (includes site of manufacture), if GMP A - pre-clearance not provided MPR Manufacturing process (other than MBS) N 13 Consumer Medicine Information (CMI) Status A/D* CPI Introduction of a CMI for a Schedule 3 product Registered after O - 4 July 1995 where the CMI complies with Schedule 13 to the Therapeutic Goods Regulations 1990 and is not to be included as a package insert. Note: Change KPI applies where the CMI is to be included as a package insert. CPO Changes to an existing CMI, where the changes are consistent O - with all previously approved product details and the CMI is not to be included as a package insert. Note: Refer to the Label Change section for guidance on changes to a CMI where the CMI is to be included as a package insert (package inserts are treated as part of the label). Product Information (PI) Status A/D*
MMA TGA-licensed Australian manufacturer (includes site of manufacture) N 5, 9 MOS Overseas manufacturer (includes site of manufacture), if GMP pre-clearance certificate provided N 5, G MOP Overseas manufacturer (includes site of manufacture), if GMP pre-clearance not provided A - MPR Manufacturing process (other than MBS) N 13 MBS Batch size for pressurised inhalation (nasal and oral respiratory) products A - MMA TGA-licensed Australian manufacturer (includes site of manufacture) N 5, 9 MOS Overseas manufacturer (includes site of manufacture), if GMP pre-clearance certificate provided N 5, G MOP Overseas manufacturer (includes site of manufacture), if GMP pre-clearance not provided A - MPR Manufacturing process (other than MBS) N 13 Consumer Medicine Information (CMI) Status A/D* CPI Introduction of a CMI for a Schedule 3 product Registered after 4 July 1995 where the CMI complies with Schedule 13 to the Therapeutic Goods Regulations 1990 and is not to be included as a package insert. Note: Change KPI applies where the CMI is to be included as a package insert. O - CPO Changes to an existing CMI, where the changes are consistent with all previously approved product details and the CMI is not to be included as a package insert. Note: Refer to the Label Change section for guidance on changes to a CMI where the CMI is to be included as a package insert (package inserts are treated as part of the label). O - Product Information (PI) Status A/D*