Commonwealth Consolidated Regulations Commonwealth Consolidated Regulations(1) For the purposes of subsections 4(1) and (1A) of the Act, this section sets out the annual charge for the registration of therapeutic goods if:
(a) the registration of the goods is in force at any time during the charge year; and
(b) the goods are of a kind mentioned in Part 1 of Schedule 10 to the Therapeutic Goods Regulations 1990 ; and
(c) either:
(i) if the goods are not grouped therapeutic goods--the goods are not a biologic; or
(ii) if the goods are grouped therapeutic goods--the goods are not biologics.
When higher and lower amounts are payable
(2) The annual charge for the goods for the charge year is:
(a) if one or more of the conditions in subsections (4) to (10) apply to the goods--$5,203; or
(b) otherwise--$4,238.
New chemical entities, extensions of indications and changes to intended patient groups
(4) The following conditions are met:
(a) the registration of the goods commenced on or after 1 July 2015;
(b) the goods are relevant goods;
(c) for goods whose registration commenced before the beginning of the charge year--at the beginning of the charge year, the goods have been registered for fewer than 8 years.
(5) Relevant goods are goods that, at the time the registration of the goods commenced, were:
(a) a new chemical entity, within the meaning of subclause 1(1) of Schedule 9 to the Therapeutic Goods Regulations 1990 ; or
(b) separate and distinct from other goods that are registered:
(i) because of an extension of indications, within the meaning of item 4 of the table in Part 2 of Schedule 9 to the Therapeutic Goods Regulations 1990 , other than an extension of indications mentioned in paragraph (bc) of that item; or
(ii) because of a change to the intended patient group (within the meaning of paragraph (e) of the definition of major variation in subclause 1(1) of Schedule 9 to those Regulations).
Goods whose parent goods have been registered for fewer than 8 years
(6) The following conditions are met:
(a) the registration of the goods commenced on or after 1 July 2015;
(b) the goods are not relevant goods;
(c) subsection (4) applies for the charge year to the parent goods of those goods.
(7) Goods (the initial goods ) are parent goods of other goods if:
(a) the initial goods were registered before the other goods; and
(b) the initial goods are relevant goods; and
(c) the initial goods and the other goods have:
(i) the same active ingredient; or
(ii) the same active ingredients in the same quantitative amounts; and
(d) at the time the registration of the other goods commenced, the other goods were registered in relation to:
(i) the person in relation to whom the initial goods were registered at that time; or
(ii) a person authorised by the person in relation to whom the initial goods were registered at that time.
Grouped therapeutic goods as a result of extension of indications or changes to intended patient group
(8) The following conditions are met:
(a) the goods are grouped therapeutic goods;
(b) relevant goods that are included in those grouped goods were grouped on or after 1 July 2015 (whether or not other goods that are included in those grouped goods were registered before that time);
(c) the grouping occurred in a financial year before the charge year;
(d) at the beginning of the charge year, the relevant goods have been included in the grouped goods for fewer than 8 years.
Entries before 1 July 2015--goods other than grouped therapeutic goods
(9) The following conditions are met:
(a) the goods are not grouped therapeutic goods;
(b) the goods (the chargeable goods ) were registered before 1 July 2015;
(c) immediately before 1 July 2015:
(i) if there is only one active ingredient contained in the chargeable goods--any other goods containing that active ingredient (and no other active ingredients) are registered in relation to the person in relation to whom the chargeable goods are registered; or
(ii) otherwise--any other goods containing the same active ingredients in the same quantitative amounts as the chargeable goods (and no other active ingredients) are registered in relation to the person in relation to whom the chargeable goods are registered;
(d) at the beginning of the charge year, the goods have been registered for fewer than 8 years.
Entries before 1 July 2015--grouped therapeutic goods
(10) The following conditions are met:
(a) the goods were grouped therapeutic goods immediately before 1 July 2015;
(b) immediately before 1 July 2015:
(i) if there is only one active ingredient contained in the grouped goods--any other goods containing that active ingredient (and no other active ingredients) are registered in relation to the same person in relation to whom the grouped goods are registered; or
(ii) otherwise--any other goods containing the same active ingredients in the same quantitative amounts as the grouped goods (and no other active ingredients) are registered in relation to the same person in relation to whom the grouped goods are registered;
(c) at the beginning of the charge year, the first of the goods to be registered have been registered for fewer than 8 years.
Note: For provisional registration of a medicine, see section 9.