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Reinstatement of an entry on the ARTG
A sponsor may request an entry be reinstated on the Australian Register of Therapeutic Goods (ARTG) if the entry was cancelled due to:
- a request received from the sponsor, or
- a decision made by the Secretary (or their delegate) to cancel the entry due to non-payment of annual charges.
The Secretary may, by notice in writing to the person, reinstate a cancelled entry, if the sponsor:
- requests reinstatement within 90 days of the cancellation
- has paid the outstanding annual charges relating to the entry, and
- has paid the prescribed application fee.
The cost associated with a reinstatement is $160 for the first entry and $50 for each additional entry.
Further information on fees and charges can be found on our schedule of fees and charges web page.
For advice on how to make a payment to the TGA please refer to our payment options web page.
The relevant sections of the Therapeutic Goods Act 1989 for re-instatement of entries are:
- Medicines: 30A for those cancelled by the sponsor and 30AA for those cancelled for non-payment of annual charges
- Biologicals: 32GD for those cancelled by the sponsor and 32GDA for those cancelled for non-payment of annual charges
- Medical devices: 41GLA for those cancelled by the sponsor and 41GLB for those cancelled for non-payment of annual charges