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THERAPEUTIC GOODS ACT 1989 - SECT 66

Transitional arrangements for goods required to be registered or listed

             (1)  This section applies to therapeutic goods in relation to a person if, immediately before the commencement of this Act, the person was supplying goods of that kind in Australia for use in humans.

             (2)  Where:

                     (a)  this section applies to therapeutic goods in relation to a person; and

                     (b)  the Secretary is not aware of the person having been convicted of an offence against a law of the Commonwealth, of a State or of an internal Territory in respect of goods of that kind during the period of 2 years ending on the commencement of this Act; and

                     (c)  if the goods are imported goods--the Secretary is not aware of the person having, during that period, imported goods of that kind into Australia otherwise than in accordance with regulations in force under the Customs Act 1901 ;

subsections 20(1) and (2) do not apply to goods of that kind in relation to the person during the period of 3 months after that commencement.

             (3)  Where:

                     (a)  this section applies to therapeutic goods in relation to a person; and

                     (b)  the person makes an application for registration or listing of goods of that kind in accordance with section 23 and within 3 months after the commencement of this Act;

then:

                     (c)  subsection 20(1) does not apply to goods of that kind in relation to the person during the period of 6 months after that commencement or before the end of such longer period as the Secretary specifies by notice published in the Gazette before the end of that first-mentioned period; and

                     (d)  subsection 20(2) does not apply to goods of that kind in relation to the person during the period of 12 months after that commencement or before the end of such longer period as the Secretary specifies by notice published in the Gazette before the end of that first-mentioned period.

          (3A)  If, on an application under subsection (3), goods have been registered without having been evaluated, the Secretary may, if he or she thinks it appropriate, give the person in relation to whom the goods are registered written notice that the goods are to be evaluated to determine whether they should continue to be registered.

             (4)  A person who makes an application in accordance with subsection (3) is not required to pay:

                     (a)  any application fee for the registration or listing of the goods to which the application relates; or

                     (b)  in the case of an application for the registration of goods--any fee for the evaluation of the goods for registration;

but where the goods are later evaluated to determine whether the goods should continue to be registered, such fee as is prescribed is payable in respect of that evaluation.

          (4A)  In relation to an evaluation conducted for the purposes of this section:

                     (a)  section 25 has effect as if:

                              (i)  the person in respect of whom the goods are registered were an applicant for the registration of the goods; and

                             (ii)  the reference in paragraph (1)(b) to an evaluation fee under section 24 were a reference to a fee payable under subsection (4) of this section; and

                     (b)  sections 24A, 24B and 24C have effect as if any reference in those sections to section 24 were a reference to subsection (4) of this section; and

                     (c)  sections 24D and 24E do not apply.

          (4B)  If, on an application under subsection (3), goods have been listed without consideration of the matters mentioned in paragraphs 26(1)(c) to (m), the Secretary may, if he or she thinks it appropriate, give the person in relation to whom the goods are listed written notice that the Secretary intends to determine whether the goods should continue to be listed.

          (4C)  If notice is given under subsection (4B), section 26 applies as if the person in relation to whom the goods are listed were an applicant for the listing of the goods.

             (5)  Section 21 does not apply, during the period of 15 months after the commencement of this Act or during such longer period as the Secretary specifies by notice published in the Gazette before the end of that first-mentioned period, to any goods.

             (6)  Where a person suffers any kind of loss, damage or injury caused by, or arising out of, the use by the person of therapeutic goods to which this section applies, no liability in respect of that loss, damage or injury attaches to the Commonwealth, the Secretary or any delegate of the Secretary.



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