Commonwealth Consolidated Regulations

THERAPEUTIC GOODS REGULATIONS 1990 - REG 11

  (1)   For paragraph   16(1A)(d) of the Act, different characteristics are:

  (a)   a different name; or

  (b)   different indications; or

  (c)   a different excipient; or

  (d)   for medicines that contain any restricted ingredients:

  (i)   a different quantity of a restricted ingredient that is an excipient; or

  (ii)   if the restriction on a restricted ingredient relates to its concentration in a relevant medicine--a different concentration of the restricted ingredient; or

  (iii)   if the restriction on a restricted ingredient relates to its quantity in the recommended single or daily dose in a relevant medicine--different directions for use setting out a different recommended single or daily dose.

  (2)   A substance is a restricted ingredient if:

  (a)   it is an ingredient in a relevant medicine; and

  (b)   for that medicine to be, or to remain, eligible for listing, the permissible quantity or concentration of the substance in the medicine is restricted by operation of any of the following:

  (i)   Schedule   4;

  (ii)   the Poisons Standard;

  (iii)   a condition imposed under section   28 of the Act;

  (iv)   a standard under section   10 of the Act;

  (vi)   any other provision in these Regulations or in the Act that deals with eligibility of medicines for listing.

  (3)   In this regulation:

"relevant medicine" means a medicine that is listable goods or listed goods and that is not an export only medicine.