Commonwealth Consolidated Acts Commonwealth Consolidated ActsWhen co - marketed brands are to be treated as one brand
(1) For the purposes of section 85AB, 2 or more brands of a pharmaceutical item that are co - marketed brands of the pharmaceutical item are to be treated as if they were only one brand of the pharmaceutical item.
Meaning of co - marketed brands
(2) 2 or more brands of a pharmaceutical item are co - marketed brands of the pharmaceutical item if:
(a) a determination is in force under subsection (3) that the brands are co - marketed brands of the pharmaceutical item; or
(b) both of the following apply:
(i) the regulations prescribe under subsection (4) that the brands are co - marketed brands of the pharmaceutical item;
(ii) there is no determination in force under subsection (3B) that the brands cease to be co - marketed brands of the pharmaceutical item.
Ministerial determination
(3) The Minister may, by legislative instrument, determine that 2 or more brands (the co - marketed brands ) of a pharmaceutical item (the co - marketed item ) are co - marketed brands of the co - marketed item if the following paragraphs are satisfied:
(a) within 4 months of the first of the co - marketed brands of the co - marketed item being included on the Australian Register of Therapeutic Goods, applications are made to include the other co - marketed brands of the co - marketed item on the Register;
(b) the first determination that is made under subsection 85(6) in relation to a brand of the co - marketed item is made only in relation to the co - marketed brands of the co - marketed item;
(c) each of the co - marketed brands is a listed brand of the co - marketed item;
(d) no other brand is a listed brand of the co - marketed item;
(e) if there is another pharmaceutical item that has the same drug as the co - marketed item:
(i) each of the co - marketed brands is a listed brand of that pharmaceutical item; and
(ii) no other brand is a listed brand of that pharmaceutical item.
(3A) The Minister may, by legislative instrument, vary or revoke a determination under subsection (3) so that all brands (the co - marketed brands ) that are co - marketed brands of a pharmaceutical item (the co - marketed item ) cease to be co - marketed brands of the co - marketed item if:
(a) any of the co - marketed brands is not a listed brand of the co - marketed item; or
(b) another brand is a listed brand of the co - marketed item; or
(c) if there is another pharmaceutical item that has the same drug as the co - marketed item:
(i) any of the co - marketed brands is not a listed brand of that pharmaceutical item; or
(ii) another brand is a listed brand of that pharmaceutical item.
(3B) The Minister may, by legislative instrument, determine that all brands (the co - marketed brands ) that are prescribed by the regulations as being co - marketed brands of a pharmaceutical item (the co - marketed item ) cease to be co - marketed brands of the co - marketed item if:
(a) any of the co - marketed brands is not a listed brand of the co - marketed item; or
(b) another brand is a listed brand of the co - marketed item; or
(c) if there is another pharmaceutical item that has the same drug as the co - marketed item:
(i) any of the co - marketed brands is not a listed brand of that pharmaceutical item; or
(ii) another brand is a listed brand of that pharmaceutical item.
Regulations
(4) For the purposes of paragraph (2)(b), on the day on which this section commences, the regulations may prescribe that 2 or more brands that are listed brands of a pharmaceutical item on that day are co - marketed brands of the pharmaceutical item.