Reinstatement of an entry on the ARTG

3 July 2017

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.

Should you wish to reinstate your entry, please complete the reinstatement form and send it to accountsrec@health.gov.au.

The cost associated with a reinstatement is $150 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.

For enquiries, including assistance with this form, please phone 1800 010 624 or email ebs@health.gov.au. For finance-related enquiries please contact 02 6221 6900 or email accountsrec@health.gov.au.

Legislative references

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