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Process to change a registered OTC medicine

V1.2, June 2017

10 July 2017

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Step 2 - Determining your application level and change codes

Applications to change an ARTG entry for a registered OTC medicine are categorised into four levels (C1-C4) based on risk and have different fees and target evaluation times.

It is important that you select the correct change codes in the changes code tables in Step 1 as these will determine the application level for you.

If you are applying to make more than one change, the change code with the highest application level determines the overall application level.

You will need the change codes to complete your application (Step 7).

The change code tables will also identify which section of the Therapeutic Goods Act 1989 you are applying under.

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