Failure to pay annual charges - regulatory actions
If a sponsor has failed to pay the annual charge for therapeutic goods within 28 days (20 working days for medical devices) after it becomes payable, the Secretary can cancel the entry of therapeutic goods in the Australian Register of Therapeutic Goods (ARTG).
The cancellation provisions relating to failure to pay annual charges in the Therapeutic Goods Act 1989 are:
- cancellation of listed or registered therapeutic goods: section 30(2)(f)
- cancellation of biologicals: section 32GA(1)(g)
- cancellation of medical devices: section 41GL(f).
The records below include information on the cancellation decisions and any subsequent decision to revoke such cancellations. To find out whether a product is currently authorised for supply in Australia, check the ARTG.