Therapeutic Goods (Charges) Regulations (Amendment) 1997 No. 161
EXPLANATORY STATEMENT
STATUTORY RULES 1997 No. 161
Issued by authority of the Parliamentary Secretary to the Minister for Health and Family Services for 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 an 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 increases to the fees made under the accompanying Therapeutic Goods Regulations (Amendment). The Therapeutic Goods Administration (the TGA), which administers the Act operates on a cost recovery basis, with revenue to be drawn from fees and charges collected from industry. The amending regulations, together with the amendments made to the Therapeutic Goods Regulations, will enable the TGA to recover 75 per cent of its operating costs from 1 July 1997.
The introduction of the Act in 1991 was accompanied by a Government requirement that TGA recover 50 per cent of its operating costs through fees and charges levied on industry. The level of cost recovery by the TGA was increased in 1996 with an initial increase to 58 per cent in 1996/97 and proposed increases to 67 per cent and 75 per cent in successive financial years. The rate of increase in cost recovery was accelerated as part of the 1997/98 Budget to recover 75 per cent of operating costs in 1997/98. The amendments contained in the proposed Amending Regulations will enable the TGA to recover 75 per cent of its operating costs through both annual charges and the collection of application and evaluation fees and inspection fees. Agreement was reached with industry for the latest increase to apply from 1 July 1997.
Details of the Regulations are as follows:
Regulation 1 provides for the Regulations to commence on 1 July 1997.
Regulation 2 provides that the Regulations be amended as set out in these Regulations.
Regulation 3 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.
The Regulations commenced on 1 July 1997.