Document ID: chunk:federal_register_of_legislation:C2010A00054:clause:1_59
Version: federal_register_of_legislation:C2010A00054
Segment Type: clause
Provision Reference: sch 1 cl 59
Character Range: 160270–161898

59  Transitional—exempt biologicals
(1) This item applies in relation to a class of biologicals that, immediately before the commencement of this item, was covered by an exemption of the kind referred to in paragraph 18(1)(c) of the Therapeutic Goods Act 1989.
(2) At the commencement of this item, there is taken to be an exemption (the transitional exemption) in force under subsection 32CA(2) of that Act covering that class of biologicals.
(3) Subject to this item, the transitional exemption ceases to be in force at the end of the period (the transitional period) of 3 years beginning on the day this item commences.
(4) If:
 (a) before the end of the period of 18 months beginning on the day this item commences, a person makes an application in accordance with section 32DA or 32DD of that Act to include in the Register a biological included in that class; and
 (b) before the end of the transitional period, the person has not been notified of the Secretary's decision on the application;
the transitional exemption, in relation to that biological, continues in force past the end of the transitional period until the person is notified of the Secretary's decision on the application.
(5) If:
 (a) before the end of the transitional period, a person makes an application in accordance with section 32DA or 32DD of that Act to include in the Register a biological included in that class; and
 (b) before the end of that period, the person is notified of the Secretary's decision on the application;
the transitional exemption, in relation to that biological, ceases to be in force immediately after that notification.