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Process to change a registered OTC medicine

V1.2, June 2017

10 July 2017

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Step 1 - Verifying your changes require prior approval

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.

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