Commonwealth Numbered Regulations - Explanatory Statements

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THERAPEUTIC GOODS (CHARGES) REGULATIONS (AMENDMENT) 1993 NO. 140

STATUTORY RULES 1993 No. 140

Issued by Authority of the Minister for Family Services

Therapeutic Goods (Charges) Act 1989

Therapeutic Goods (Charges) Regulations (Amendment)

The Therapeutic Goods (Charges) Act 1989 (the Act) imposes an annual charge for the registration and listing of therapeutic goods in the Australian Register of Therapeutic Goods, and an annual charge for licences to manufacture therapeutic goods.

Subsection 5(1) of the Act empowers the Governor-General to make regulations, not inconsistent with the Act, prescribing the amounts of those charges.

The increases in charges contained in the Regulations have been made in conjunction with the increases in fees made under the accompanying Therapeutic Goods Regulations (Amendment). The increases have been necessitated by the need to meet the Government's decision of August 1989 that the Therapeutic Goods Administration, which administers the Act, operate on a fifty pet cent cost recovery basis, with revenue to be drawn from fees and charges collected from industry. To minimise the impact of the increase in charges to industry, it has been agreed between industry and Government that the proposed higher charges will be phased in over a four year period. The Therapeutic Goods (Charges) Regulations (Amendment) therefore introduce the first incremental increases to a range of annual charges for maintaining registrations and listings of therapeutic goods in the Australian Register of Therapeutic Goods (the Register), and to a range of manufacturing licences issued for either different kinds of therapeutic goods or for different kinds of manufacturing processes.

Details of the Regulations are as follows.

Regulation 1 provides for the Regulations to commence on 1 July 1993.

Regulation 2 provides for the Therapeutic Goods (Charges) Regulations to be amended as provided in these Regulations.

Subregulation 3.1 increases the annual charge for registrations of prescription drugs in the Register from $350 to $400.

Subregulation 3.2 increases the annual charge for registrations of all other therapeutic goods from $175 to $210.

Subregulation 3.3 increases the annual charge for listings of therapeutic goods. Therapeutic goods listed in the Register that are produced for export only do not attract an annual charge for their listing.

Subregulations 3.4, 3.5 and 3.6 increase annual licensing charges payable for three broad categories of manufacturing licences - those for the manufacture of therapeutic goods or their containers, those for the manufacture of ingredients or components of therapeutic goods, or a single step of manufacture or the manufacture of a single product, and those for the manufacture of herbal or homoeopathic preparations not included in a Schedule to the Poisons Standard.

Regulation 4 amends subregulation 4(1) of the Charges Regulations by resetting the formula for determining the cut-off point at which annual registration/listing charges would not be payable by a sponsor whose wholesale turnover of therapeutic goods is of "low volume and low value". Currently, the formula is set at 2 per cent of the value of the wholesale turnover. This is to be replaced by 5 per cent.

The Regulations commence on 1 July 1993.