Therapeutic Goods Act 1989

This section applies to an application for listing or registration of a therapeutic good under section 23 if:

the therapeutic good is, or contains, a GM product or a genetically modified organism; and

if the application is for registration—the application has passed preliminary assessment; and

if the application is for the listing of a medicine under section 26AE—the application has passed preliminary assessment.

Subject to subsection (5), the Secretary must give written notice to the Gene Technology Regulator:

stating that the application has been made; and

requesting the Gene Technology Regulator to give advice about the application.

If the Secretary gives the Gene Technology Regulator a notice under subsection (2), the Gene Technology Regulator may give written advice to the Secretary about the application.

The advice is to be given within the period specified in the notice.

If an advice from the Gene Technology Regulator is in force under section 30D in relation to a class of therapeutic goods, the Secretary is not required to notify the Regulator under this section in relation to an application for listing or registration of a therapeutic good belonging to that class.