Cancellation of "registered" and "listed" products from the ARTG

29 October 2007

What will happen to registered entries

The TGA is working systematically through the ARTG to ascertain which products are required to transition and which are not and, of those required to transition, which products have completed transition, which products are under but have not yet completed transition, and which products are not transitioning.

NOTE: Register entries for those devices required to transition but for which no attempt to do so has been made have not been automatically removed from the Register as of 4 October 2007. However, the continued presence of an entry on the ARTG does NOT override the date at which the entry is taken to be cancelled as set out in subsection 9B(2) of the Act, which is the date beyond which the sponsor can no longer lawfully supply the product.

If a product was required to be transitioned and its sponsor did not lodge an effective application for inclusion in the ARTG or for TGA Conformity Assessment certification by the end of 3 October 2007, the product will be taken to have been cancelled from the Register on 4 October 2007 for the purposes of determining the legality of supply of that product.