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Changing an OTC medicine: using the Changes Tables

Version 2.4, 4 December 2017

4 December 2017

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Change table: Consumer Medicine Information (CMI)

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
Change codes Consumer Medicine Information (CMI) Status codes Assurance codes Application level Applicable section of the Act
CPI

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.

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 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).

O

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