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THERAPEUTIC GOODS ACT 1989 - SECT 32DS

Consultation with Gene Technology Regulator

             (1)  This section applies to an application for inclusion of a biological in the Register if the biological is, or contains, a GM product or a genetically modified organism.

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

                     (a)  stating that the application has been made; and

                     (b)  requesting the Gene Technology Regulator to give advice about the application.

             (3)  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.

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

             (5)  If an advice from the Gene Technology Regulator is in force under section 32DT in relation to a class of biologicals, the Secretary is not required to notify the Gene Technology Regulator under this section in relation to an application for inclusion in the Register of a biological belonging to that class.

             (6)  A notice under subsection (2) is not a legislative instrument.



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