Cancellation of a therapeutic good at sponsor request
May 2009
An annual charge for the current financial year remains payable following the cancellation of an entry of a therapeutic good entered on the Australian Register of Therapeutic Goods (ARTG) by a Sponsor.
Key points
- Sponsors may cancel an entry on the ARTG at any time by submitting a form signed by an authorised officer.
- Cancellation of an entry on the ARTG takes effect immediately following acceptance by the TGA of the request from the Sponsor.
- It is an offence to continue to supply or export a therapeutic good that has been cancelled from the ARTG.
- Care should be taken - once cancelled, a new application would be required to continue supply of a product or device.
- A Sponsor is still liable for any unpaid annual charge in respect of a cancelled product.
- Annual charges are debts owing to the Commonwealth.
Procedures
Annual charges are payable in relation to an entry of a therapeutic good on the ARTG at any time during a financial year.
A Sponsor may elect to cancel an entry on the ARTG at any time by submitting a form signed by an authorised officer. However, the sponsor remains liable for the payment of the annual charge for the financial year in which a request for cancellation has been made.
Annual charges invoices for the 2009/10 financial year will be sent to sponsors early in July 2009. These invoices will cover all products entered on the ARTG as at 1 July 2009. Any ARTG entry in respect of which a cancellation request is not received by the TGA before 1 July 2009 will be liable for the 2009/10 annual charge. It is in sponsor's interest to submit an application before 1 July 2009 if they wish to cancel any ARTG entry and do not want to incur a liability for the 2009/10 annual charge.
It should be noted that the TGA does not have power to reduce or waive annual charge, other than low value turnover exemption. Annual charges are debts owing to the Commonwealth. Sponsors remain liable for the payment of an annual charge (or an instalment of an annual charge) outstanding following a cancellation at a Sponsor's request.
Forms
- Sponsor cancellations - Authorisation to cancel a product from the Australian Register of Therapeutic Goods <http://www.tga.gov.au/fees/forms/artg-cancel.htm>
Assistance
TGA Revenue Manager: Facsimile 02 6232 8222 or by email to TGA.Accounts@tga.gov.au.
References
- Summary of TGA fees and charges
<http://www.tga.gov.au/docs/html/feesach.htm#fees>