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Therapeutic Goods Amendment (Medical Devices and Other Measures) Act 2009

On Wednesday 17 June 2009 the Governor-General Ms Quentin Bryce AC, gave Royal Assent to the Therapeutic Goods Amendment (Medical Devices and Other Measures) Act 2009: Act number 38 of 2009. The Act is available on the ComLaw website.

The Act:

  • from 18 June 2009:
    • medical devices are exempted in certain circumstances, as are medicines, from provisions in the Therapeutic Goods Act 1989. This will allow medical devices to be stockpiled to deal with possible emergencies or be made available quickly in the case of actual emergencies;
    • a wider range of therapeutic goods information can now be provided to the public and the TGA can now release information to Commonwealth agencies or international authorities under a wider range of circumstances to support safety and quality in therapeutic goods;
    • advertisements that contain restricted representations, both pre-approved and others, are now subject to the same requirements.
  • On 1 July 2009 the amendments allowing medicines and other therapeutic goods, that are not medical devices, to meet the requirements of the European Pharmacopoeia or the United States Pharmacopoeia as alternatives to the British Pharmacopoeia will commence. For further information see: Questions and answers relating to the additional default standards legislation
  • On a day to be proclaimed the amendments to better target the 'fit and proper person' test will come into effect.

The Act principally implements enhancements identified during the development of the Australia New Zealand Therapeutic Products Authority (ANZPTA) and is the first of a package of reforms. Further legislative amendments are to follow.