Commonwealth Numbered Regulations - Explanatory Statements

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THERAPEUTIC GOODS (CHARGES) REGULATIONS (AMENDMENT) 1995 NO. 193

STATUTORY RULES 1995 No. 193

Issued by authority of the Minister for Family Services

Therapeutic Goods (Charges) Act 1989

Therapeutic Goods (Charges) Regulations (Amendment)

The Therapeutic Goods (Charges) Act (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 maintaining licenses 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 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 (the TGA), 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 increases 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 third incremental increase to a range of annual charges for maintaining registrations and listings of therapeutic goods in the Register, and to a range of manufacturing licenses 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 1995.

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 $440 to $500.

Subregulation 3.2 will increase the annual charge for registrations of all other therapeutic goods from $250 to $300.

Subregulation 3.3 will increase the annual charge for listings of therapeutic goods from $110 to $150. 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, 3.6, 3.7, 3A, 3.9, 3.10 and 3.11 increase annual licensing charges payable for various categories of manufacturing licenses set out under subregulation 3(2) of the Therapeutic Goods (Charges) Regulations. The increases will raise the present charges from $3,800 to $4,200; from $1,900 to $2,100; and from $1,600 to $2,000.

The Regulations commenced from 1 July 1995.