Cancellation of a therapeutic good for non-payment of an annual charge

Therapeutic products entered on the Australian Register of Therapeutic Goods (ARTG) may be cancelled by the TGA for non-payment of an annual charge.

Key points

• Non-payment of an annual charge by the due date may result in the cancellation of an entry from the ARTG.
• Cancellation will take effect on the date specified on the notice of cancellation.
• Annual charges are debts owing to the Commonwealth.
• It is an offence to continue to supply or export a therapeutic good that has been cancelled from the ARTG.
• A sponsor may request a review of the decision under section 60 of the Therapeutic Goods Act.

Procedures

Reasons for cancellation

The TGA may cancel an entry on the ARTG for non-payment of an annual charge.

The TGA regularly reviews outstanding debts. If an annual charge for a therapeutic good is not paid within 28 days (20 working days for medical devices) after it became payable, the TGA has the power to cancel the entry from the ARTG.

It is important to note that the sponsor remains liable for the outstanding annual charges as these are debts owing to the Commonwealth.

Sponsors should continue to ensure their postal and billing addresses on TGA's electronic business system are maintained to avoid misdirection of an invoice.

Following cancellation

A notice of the decision to cancel an entry will be published in the Commonwealth Gazette or on the website.

Cancellation for non-payment is an initial decision within the meaning of subsection 60(1) of the Therapeutic Goods Act. A request for ministerial review of an initial decision must be made within 90 days of the notice being given to the sponsor.

Once an entry is cancelled, a new approval is required to enable continued supply of the therapeutic good.

If an application is approved it will result in a new entry on the ARTG and all relevant application and evaluation fees are payable.

Assistance

References

Therapeutic Goods Act 1989

• Paragraphs 30(2)(f), 32GA(1)(g) and 41GL(f) provide for the cancellation of therapeutic goods for non-payment of an annual charge.
• Section 60 provides for the review of decisions.