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Changing an OTC medicine: using the Changes Tables
Version 2.4, 4 December 2017
Change table: Consumer Medicine Information (CMI)
|Change codes||Consumer Medicine Information (CMI)||Status codes||Assurance codes||Application level||Applicable section of the Act|
Introduction of a CMI for a 'Pharmacist Only Medicine' (Schedule 3) product registered after 4 July 1995 where the CMI complies with Schedule 13 to the Therapeutic Goods Regulations and is not to be included as a package insert.
Note: Change KPI or KPD applies where the CMI is to be included as a package insert.
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 Labelling (including package insert) and product detail changes 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).