Cancellation of a therapeutic good for non-payment of an annual charge
April 2007
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 (including an instalment) by the due date will result in the cancellation of an entry of a therapeutic good from the ARTG.
- Cancellation will take effect on the date specified on the notice of cancellation (immediately in the case of a medical device).
- It is an offence to continue to supply or export a therapeutic good that have been cancelled from the ARTG.
- Cancellation decisions made by the TGA are published in the Commonwealth Gazette.
- A Sponsor may request a review of the decision to cancel an entry from the ARTG for non-payment.
Procedures
The TGA may cancel an entry on the ARTG for various reasons in accordance with the Therapeutic Goods Act and Regulations. This includes cancellation for non-payment of an annual charge.
The TGA regularly reviews outstanding debtors and provides Sponsors with overdue invoices with a first and final reminder notice within 14 days following the due date for payment.
- it is important that Sponsors ensure their postal and billing addresses on SIME are maintained to avoid misdirection of an invoice and/or reminder notices.
An Annual Charges Statement will be issued prior to the due date for payment of second and subsequent instalments of annual charges.
Payment of an annual charge (or instalment) of a therapeutic good that is more than 28 days overdue (20 working days for medical devices) will be cancelled for non-payment. Where payment of an instalment is overdue, the full balance of the annual charge becomes payable immediately.
The TGA will write to Sponsors notifying its intention to cancel an entry from the ARTG, usually thirty (30) days from the date of the notice. Sponsors may provide a written submission setting out the circumstances why cancellation should not proceed, together with the overdue payment.
Where no submission has been made by a Sponsor by the required date (or where the delegate is not satisfied with the matters set out in a Sponsor's submission), the TGA will proceed to cancel the product entry from the ARTG for non-payment.
A notice of the decision to cancel an entry will be published in the Commonwealth Gazette.
Once cancelled, a fresh application is required to enable continued supply of the product or device. The application will result in a new entry on the ARTG and all relevant application and evaluation fees are payable.
Cancellation for non-payment is an initial decision within the meaning of subsection 60(1) of the Therapeutic Goods Act.
Sponsors may request a review of the decision to cancel a product for non-payment within 90 days of the gazettal notice. The request must be made in writing.
Forms
Not applicable
Assistance
TGA Revenue Manager: Facsimile 02 6232 8222 or by email to TGA.Accounts@tga.gov.au.
References
Therapeutic Goods Act 1989
- Paragraphs 30(2)(f) and 41GL(f) provide for the cancellation of a good for non-payment of an annual charge.
- Subsection 60(1) review of decisions.