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Therapeutic Goods Amendment (2009 Measures No 1) Act 2009

On Thursday 27 August 2009, the Governor-General Ms Quentin Bryce AC, gave Royal Assent to the Therapeutic Goods Amendment (2009 Measures No 1) Act 2009: Act No. 76., 2009. The Act is available from the ComLaw website.

From Friday 28 August:

  • medicines and therapeutic devices will be able to be suspended rather than fully cancelled in certain circumstances;
  • monitoring of facilities will now be able to include the taking of video and other recordings and taking of samples of things related to therapeutic goods on premises;
  • other minor amendments including clarifying the definition of accessory to a medical device and requiring that medicine labels not make claims that are inconsistent with the claims approved for the product; and
  • minor technical amendments to the expression of legislative instruments in the Act.

From 1 July 2011:

  • a new framework for the regulation of homoeopathic and anthroposophic medicines will come into effect. Details of the framework will be set out in regulations and other subordinate legislation made under the Act. Further consultation with industry will occur on the development of this detail.

From dates to be proclaimed, as indicated below, the following will be enabled:

  • manufacturing licenses to cover single sites, except in certain circumstances, and enabling variation and transfer of licenses to another manufacturer - to commence on 25 February 2010;
  • the Minister will be able to determine lists of ingredients that are permitted and prohibited to be included in listed medicines. Applications will be able to be made to ask that an ingredient be included in the permitted ingredients list - to commence on 8 February 2010; and
  • other amendments including clarification of the way conditions are set on registered and listed goods and clarifying the Advertising Code as a legislative instrument - to commence on 25 January 2010.