Commonwealth Numbered Regulations - Explanatory Statements

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THERAPEUTIC GOODS (CHARGES) REGULATIONS (AMENDMENT) 1996 NO. 132

STATUTORY RULES 1996 No. 132

Issued by Authority of the Minister for Health and 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 maintaining 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 purpose of the Therapeutic Goods (Charges) Regulations (Amendment) is to Introduce the fourth 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 licences issued for the manufacture of therapeutic goods. 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 Therapeutic Goods Administration (the TGA), which administers the Art, Is required to 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 with industry that the higher charges will be phased In over a four year period.

Details of the Regulations are as follows:

Regulation 1 provides for the Regulations to commence on 1 July 1996.

Regulation 2 sets out the table of increases to the charges currently applying under various regulations of the Therapeutic Goods (Charges) Regulations, These changes have been agreed to by Industry and represent the fourth and final incremental increase to the charges covering a four-year period.

The Regulations commence on 1 July 1996.