Supply of products for which there is an effective application to transition
29 October 2007
On 14 September 2007 the Therapeutic Goods Amendment Act 2007 (Amendment Act) was passed. This amends subsection 9B(2) of the Therapeutic Goods Act 1989, and provides for any registered or listed device in the ARTG that was the subject of an effective application for either inclusion in the ARTG or TGA Conformity Assessment Certificate submitted by the 4 October 2007 deadline, to be treated as a transitioning device and continue to be supplied under the terms and conditions of Chapter 3 of the Therapeutic Goods Act 1989 (the Act) until such time as the application is finally determined. Once the device is included in the ARTG, the registration or listing under Chapter 3 of the Act will be removed from the Register and all subsequent supply of the product must be in accordance with the terms and conditions set out in Chapter 4.
The changes provided for in the Amendment Act allow companies to be able to give assurances to purchasing authorities, hospitals and health departments that they can honour existing contractual obligations after 4 October 2007. Similarly, companies may organise deliveries of new stock from overseas on this basis.
Of course, there may be circumstances where the application for inclusion in the ARTG or for TGA Conformity Assessment certification of a transitioning device is rejected. In these cases, under the provisions of the Amendment Act, the registration or listing of the product under Chapter 3 of the Act will be taken to have been cancelled from the time at which the application has been finally determined. This means that any importation, manufacture, exportation or supply of the product by the sponsor occurring from 4 October 2007 up to the time of determination of the application is lawful. Once the registration or listing is cancelled the product can no longer be imported, manufactured, exported or supplied in Australia by the sponsor. However, any stock that has been sold to distributors, purchasing authorities, hospitals and healthcare providers before the date of cancellation can be on-supplied by those parties and used for the treatment of patients.
Supply of non transitioning product
Some companies, for a number of reasons, will have made no attempt to transition their products, in which case the registration or listing of the device will be taken to be cancelled on 4 October 2007, at which point the sponsor of the product can no longer import the product into Australia, manufacture the product in Australia, export the product from Australia or supply the product in Australia.
Stocks of non transitioning product that have been sold to distributors, purchasing authorities, hospitals and healthcare providers before 4 October 2007 can be on-supplied by those parties and used for the treatment of patients until those stocks are exhausted.