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NATIONAL HEALTH ACT 1953 - SECT 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)   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.


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