Cancellation of a therapeutic good at sponsor request
April 2007
Annual charges remain 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 may not be liable for payment for a cancellation where the TGA accepts the cancellation prior to the due date of an invoice for annual charges.
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.
- an authorisation received prior to the due date for payment of annual charges invoices (where supply of the product had ceased prior to the commencement of the financial year) will be accepted and no liability for an annual charge will remain.
An entry on the ARTG cannot be restored where a Sponsor has made a genuine mistake. Once cancelled, a fresh application must be made resulting in a new entry on the ARTG. All applicable application and/or evaluation fees will be payable.
It should be noted that 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>