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Most changes to an ARTG entry for a registered OTC medicine require our approval prior to making the change to the medicine.
To determine whether your change requires prior approval check changes code tables.
If your change is identified as:
- 'SRR', 'SAR', 'N' or 'A', you will need to apply for approval prior to making the change to the medicine. Go to Step 2.
- 'New'. Go to OTC medicines registration process as you will need to apply for a new ARTG entry.
- 'O', you do not need to apply for approval to make the change.