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Cost recovery impact statement - Good manufacturing practice, 1 July 2013 - 30 June 2014

28 June 2013

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2. Policy and legal authority to cost recover

2.1 Policy authority

The TGA has been progressively increasing the level of cost recovery from industry since 1992-93. In the 1997-98 Budget, the Government agreed that the TGA would accelerate the rate of increase in the level of cost recovery from industry to 100 percent cost recovery of all its activities by 1998-991. Government has not changed this decision in subsequent years. This policy authority encompasses recovering expenses incurred by the TGA in the regulation of therapeutic medicines manufacture.

As part of the 2012-13 Mid-Year Economic and Fiscal Outlook2, the Government agreed that the cost of the TGA reform program, detailed in the report TGA reforms: a blueprint for TGA's future3, should be recovered from the regulated industry through the existing arrangements. This measure has resulted in a small increase to the fees and charges over the period 2012-13 to 2015-16.

2.2 Legal authority

The Therapeutic Goods Act 1989 (the Act) provides a legal authority for the TGA to charge for its regulatory activities within the scope of the Act on a cost recovery basis. Applicable fees and charges are prescribed in the TG Regulations made under the Act and the Therapeutic Goods (Charges) Act 1989 (the Charges Act). These regulations are Therapeutic Goods (Charges) Regulations 1990 and the Therapeutic Goods Regulations 1990.


Footnotes

  1. 1997-98 Budget Paper 2, Revenue Measures, Other Measures p 203.
  2. http://www.budget.gov.au/2012-13/content/myefo/html/09_appendix_a_expense-10.htm
  3. http://www.tga.gov.au/about/tga-reforms-blueprint.htm

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