Commonwealth Numbered Regulations

1990 No. 395 THERAPEUTIC GOODS (CHARGES) REGULATIONS - REG 3

3. (1) For the purposes of subsection 4 (1) of the Act, the annual charges for
the registration or listing of therapeutic goods are:

   (a)  for therapeutic goods whose registration is in force at any time
        during a financial year:

   (i)  if the goods are drugs that are included in Schedule 4 or 8 to the
        Poisons Standard - $350; or

   (ii) in any other case - $175;

   (b)  for therapeutic goods (other than therapeutic goods produced for
        export) whose listing is in force at any time during a financial year
        - $60.

(2) For the purpose of subsection 4 (2) of the Act, the annual charge for a
licence that is in force at any time during a financial year is:

   (a)  if the licence is for:

   (i)  the manufacture of therapeutic goods; or

   (ii) the manufacture of containers in which therapeutic goods are to be
        packed;
$3,000; or

   (b)  if the licence is for:

   (i)  the manufacture of ingredients or components for use in the
        manufacture of therapeutic goods; or

   (ii) a single step in the manufacture of therapeutic goods; or

   (iii) the manufacture of a single drug or device that is, or is represented
        to be, sterile;
$1,500; or

   (c)  if the licence is for the manufacture of herbal or homoeopathic
        preparations that are not included in a Schedule to the
        Poisons Standard - $1,000.

(3) If, but for this subregulation, more than one charge referred to in
subregulation (1) or (2) would otherwise apply in respect of a financial year
in relation to:

   (a)  the registration or listing of particular goods; or

   (b)  a particular licence; the charge that is the greatest applicable
        charge is the only charge that applies in respect of the registration
        or listing of those goods or in relation to that licence in that year.