Document ID: chunk:federal_register_of_legislation:C2007A00111:clause:1_84ae
Version: federal_register_of_legislation:C2007A00111
Segment Type: clause
Provision Reference: sch 1 cl 84AE
Character Range: 8650–10719

84AE  Co‑marketed brands

When 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) the Minister determines under subsection (3) that the brands are co‑marketed brands of the pharmaceutical item; or
 (b) the regulations prescribe that the brands are 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 co‑marketed brands satisfy the following:
 (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) no determination is in force under subsection 85(6) in relation to a brand of a pharmaceutical item that has the same drug as the co‑marketed item (other than the co‑marketed brands of the co‑marketed item).

Note: For the purposes of paragraph (c), the brand mentioned in that paragraph may be same as one of the co‑marketed brands, or the pharmaceutical item mentioned in that paragraph may be the same as the co‑marketed 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.