Commonwealth Numbered Regulations - Explanatory Statements

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THERAPEUTIC GOODS (CHARGES) REGULATIONS (AMENDMENT) 1998 NO. 246

STATUTORY RULES 1998 NO. 246

Issued by authority of the Minister for Health and Family Services

Therapeutic Goods (Charges) Act 1989

Therapeutic Goods (Charges) Regulations (Amendment)

The object of the Therapeutic Goods Act 1989 (the Act) is to establish and maintain a national system of controls for the quality, safety, efficacy and timely availability of therapeutic goods that are used in Australia or are exported from Australia. The Therapeutic Goods Administration (the TGA) is responsible for administering the Act.

The Therapeutic Goods (Charges) Act 1989 (the Charges 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 maintaining licenses to manufacture therapeutic goods. Subsection 5(1) provides that the Governor-General may make regulations, not inconsistent with the Charges Act, prescribing the amounts of those charges.

The purpose of the regulations is to implement the final stage of the decision that TGA is to recover from industry the total cost of the regulation of therapeutic goods. To achieve 100% cost recovery it is necessary to increase a range of fees and charges. To minimise the impact on industry of the increases in charges, industry and Government agreed to phase in these increases. In framing the 1997/98 Budget, Government decided to increase the level of cost recovery from 75% in 1997/98 to 100% in 1998/99. TGA has consulted with industry about the increases.

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 Therapeutic Goods (Charges) Regulations (Amendment) increases in a range of annual charges for maintaining:

*       registrations and listings of therapeutic goods in the Australian Register of Therapeutic Goods

*       therapeutic goods manufacturing licences.

Details of the regulations are:

Regulation 1 provides for the Regulations to commence on 1 August 1998.

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

Subregulations 3.1 and 3.2

One annual charge previously covered the registration of both drugs and therapeutic goods. After consultation with industry it has been agreed that there will be separate charges for registered prescription drugs, registered non-prescription drugs and registered therapeutic devices. The effect of the subregulation is to increase the annual charges from $390 to:

*       $750 for prescription drugs

*       5455 for non-prescription drugs

*       5490 for therapeutic devices.

Subregulation 3.3 changes the item for the annual charge of $220 for listings of therapeutic goods to one that covers:

*       listed drugs, and increases the charge to $270

*       listed therapeutic devices, and increases the charge to $300.

Subregulations 3.4 and 3.5 increase the annual charge for registrations or listings of grouped therapeutic goods:

*       for drugs in Poisons Standard Schedules 4 or 8, from $620 to 5750

*       for other therapeutic goods, from $390 to $455

If grouped therapeutic goods are produced for export only the annual charges increase:

*       for grouped drugs, from $200 to $270

*       for grouped therapeutic devices, from $200 to 53 00.

Subregulation 3.6 changes the item for the annual charge of $200 for registrations or listings of grouped therapeutic goods that are not exported to one that covers: listed grouped drugs, and increases the charge to $270 listed grouped therapeutic devices, and increases the charge to $300.

Subregulations 3.7 and 3.8 increase annual licensing charges payable for various categories of manufacturing licences set out under subregulation 3(2) of the Therapeutic Goods (Charges) Regulations. The increases raise the charges of $2,690 to $3,500; and $5,620 to $6,800.

Subregulation 4.1 increases the benchmark for the annual charge for registrations or listings of low volume or low value therapeutic goods from 5% to 6% of the actual or estimated turnover of the goods.

The Regulations commence on 1 August 1998.