Commonwealth Consolidated Acts

NATIONAL HEALTH ACT 1953 - SECT 84AE

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)  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.