Memorandum of understanding (Therapeutic Goods Administration)

Date published

This Memorandum of Understanding (MOU) establishes a framework for coordination between the Therapeutic Goods Administration (TGA) and the Australian Competition and Consumer Commission (ACCC).

The MOU covers how the agencies will work together from 11 April 2023 to facilitate:

  • efficient administration of regulatory and legislative responsibilities
  • effective operational liaison and efficient information exchange between the agencies and
  • coordination (where relevant) of public announcements, ministerial briefings and legislative and administrative changes.

Under the MOU, the TGA is the lead agency for recalls and other safety issues for products that are ‘therapeutic goods’ as defined in section 3 of the Therapeutic Goods Act 1989. The ACCC is the lead agency where the therapeutic good is also a ‘consumer good’ as defined in section 2 of the Australian Consumer Law (ACL) and the safety issue has arisen from non-compliance with a safety standard or ban or a safety information standard (under Part 3-3 and Part 3-4 of the ACL respectively).

The lead agency’s functions include:

  • risk identification and assessment to control or reduce safety risks
  • risk management including encouraging suppliers to take appropriate action, issuing public health warnings, enforcement strategies, responding to media requests etc
  • voluntary and compulsory recalls
  • receiving, assessing and referring incident reports.

From January 2023, voluntary recalls of therapeutic goods will now only be published on the TGA alerts website. Any goods that are the subject of an ACL Safety Standard or Ban, will however be mirrored and published on the ACCC’s Product Safety Australia website.

You can browse all recalls and sign up to receive email updates.

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