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Therapeutic Goods Amendment (2009 Measures No 2) Act 2009

On Tuesday 29 September 2009, the Governor-General Ms Quentin Bryce AC, gave Royal Assent to the Therapeutic Goods Amendment (2009 Measures No 2) Act 2009: Act No. 96 of 2009. The Act is available on the ComLaw website.

From Wednesday 30 September 2009:

  • the Secretary of the Department of Health and Ageing (under which the Therapeutic Goods Administration, TGA, operates) will be able to declare purposes for which a kind of medical device cannot be included in the Australian Register of Therapeutic Goods and thus made available
  • the circumstances in which consultation can occur with the Gene Technology Regulator will be extended to therapeutic goods that are or contain genetically modified organisms (in addition to genetically modified products currently provided for under the Act)
  • the advertising provisions will provide that it is an offence for any person to advertise a therapeutic good inappropriately for a purpose that has not been accepted in relation to the product
  • the delegation provisions will enable the regulations to specify a relevant person for the purposes of exercising delegation under section 19A of the Act.

From a date to be proclaimed:

  • the Minister will be able to specify, by legislative instrument, advisory statements required to be included on the labels of specified medicines.

From 1 July 2010:

  • New arrangements for the separate scheduling of medicines and chemicals will come into effect.