Changes to consumer medicine information, including change codes, the change that can be made using this code, the status of the code, the assurance code, the application level for the change and the section of the therapeutic goods act that applies to the change
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.
The Department of Health and Aged Care acknowledges First Nations peoples as the Traditional Owners of Country throughout Australia, and their continuing connection to land, sea and community. We pay our respects to them and their cultures, and to all Elders both past and present.