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Therapeutic Goods Amendment (2009 Measures No 3) Act 2010

On Monday 31 May 2010, the Governor-General Ms Quentin Bryce AC, gave Royal Assent to the Therapeutic Goods Amendment (2009 Measures No 3) Act 2010, and the associated Therapeutic Goods (Charges) Amendment Act 2010.

The Act makes a number of amendments, principally to:

  • Implement a new framework for the regulation of biologicals (human cellular and tissue based therapy products) – to commence on a day to be proclaimed within 12 months of Royal Assent
  • Provide more flexible arrangements to recall batches of goods – commenced on 1 June 2010, the day after the Act received Royal Assent
  • Enable information to be sought from past sponsors of medicines and therapeutic devices but only for the 5 year period before the request is made – commenced on 1 June 2010, the day after the Act received Royal Assent, and
  • Improve the operation of the Act through a range of minor technical amendments – commenced on 1 June 2010, the day after the Act received Royal Assent.

The Therapeutic Goods (Charges) Amendment Act 2010 principally supports the new Biologicals regulatory framework by providing that annual charges will be payable in respect of the inclusion of biologicals in the Australian Register of Therapeutic Goods. This Act is to commence on the same day as the Biologicals framework.