Commonwealth Numbered Regulations - Explanatory Statements

[Index] [Search] [Download] [Related Items] [Help]

THERAPEUTIC GOODS (CHARGES) REGULATIONS (AMENDMENT) 1994 NO. 223

Statutory Rules 1994 No. 223

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 (the Register), and an annual charge for licences to manufacture therapeutic goods.

Subsection 5(1) of the Act provides that the Governor-General may 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 prompted by the need to meet the Government's decision in August 1989 that the Therapeutic Goods Administration, which administers the Act, operate on a fifty per 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 was agreed between industry and Government that the higher charges will be phased in over a four year period. The Therapeutic Goods (Charges) Regulations (Amendment) Introduce the second Incremental Increases to a range of annual charges for maintaining registrations and listings of therapeutic goods In the Register, and to a range of manufacturing licences issued for the manufacture of therapeutic goods.

Details of the Regulations are as follows.

Regulation 1 provides for the Regulations to commence on 1 July 1994.

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

Subregulation 3.1 will increase the annual charge for registrations of prescription drugs in the Register from $400 to $440.

Subregulation 3.2 will increase the annual charge for registrations of all other therapeutic goods from $210 to $250.

Subregulation 3.3 will increase 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 the annual charges for maintaining registrations and listings of grouped therapeutic goods included in the Register. For registered grouped prescription drugs the annual charge will increase from $400 to $440. For any other registered grouped goods, the annual charge for maintaining each grouping increases from $210 to $250. The annual charge for maintaining listings of grouped goods, except for grouped goods that consist entirely of goods produced for export, will increase from $90 to $110.

Subregulation 3.7 will increase annual licensing charges payable for the various categories of manufacturing licences act out under Subregulation 3(2) of the Therapeutic Goods (Charges) Regulations. The increases will raise the present charges from $3,400 to $3,800; from $1,700 to $1,900; and from $1,200 to $1,600.

The Regulations commenced on 1 July 1994.