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.

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

The cost associated with a reinstatement can be found under "General Fees" in the Schedule of fees and charges.

For advice on how to make a payment to the TGA refer to our payment options web page.

For enquiries, including assistance with this form, phone 1800 010 624 or email ebs@health.gov.au. For finance-related enquiries contact 1800 241 615 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