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Safety information for industry

The Australian community expects therapeutic goods in the marketplace to be safe, of high quality and of a standard at least equal to that of comparable countries.

The pages linked below contain information for sponsors and manufacturers.

Recalls & alerts

  • Recalls
    A recall action is an action taken to resolve a problem with a therapeutic good already supplied in the market for which there are issues or deficiencies in relation to safety, quality, efficacy (performance) or presentation
  • Alerts
    Safety alerts and advisory statements about medicines and medical devices in Australia
  • Uniform recall procedure for therapeutic goods (URPTG)
    The uniform recall procedure for therapeutic goods provides a consistent approach for undertaking recall and non-recall actions of therapeutic goods supplied, imported into or exported from Australia
  • Product contamination & extortion - a protocol for the therapeutic goods industry
    Developed by the Industry Government Crisis Management Committee as a joint industry-government initiative, with the aim of assisting managers in responding to a product contamination and/or extortion event directed at the therapeutic goods industry

Reporting problems

Product Information/Consumer Medicine Information

  • Improved Consumer Medicine Information template
    9 September 2019 The TGA, in consultation with consumer, health professional and pharmaceutical industry representatives, has developed an improved template for CMI
  • Product Information (PI)
    A new Product Information (PI) form was approved on 8 November 2017, with a commencement date of 1 January 2018. The new format is being introduced with a 3 year transition period, ending 31 December 2020.

Safety monitoring

Transmissible spongiform encephalopathies (TSEs)