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Process to change a registered OTC medicine
V1.2, June 2017
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.
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.