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Uniform recall procedure for therapeutic goods (URPTG)

16 April 2012

The Uniform Recall Procedure for Therapeutic Goods (URPTG) defines the action to be taken by health authorities and sponsors when therapeutic goods for use in humans, for reasons relating to their quality, safety or efficacy, are to be removed from supply or use, or subject to corrective action.

The URPTG also contains contact details for the Australian and State/Territory recall coordinators for reference by sponsors in case of product recall. These contact details are verified quarterly and updated on this website.

While most recalls are initiated by sponsors, recall action is underpinned by the Therapeutic Goods Act 1989 and, in accordance with the provisions of the Act, the Secretary to the Department of Health and Ageing may require the recovery of therapeutic goods.

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URPTG

The URPTG includes the Recall coordinators' contact details that are also available separately below.

Recall coordinators

Contents of the URPTG

  1. Preamble and definitions
  2. Stages of recall procedure
  3. Notification / initiation of recall
  4. Crisis management (including tampering of therapeutic goods)
  5. Information required for assessment of recall
  6. Assessment of recall (strategy, classification and level)
  7. Recall letters, paid advertisements and media releases
  8. Responsibilities of sponsors
  9. Responsibilities of Australian Recall Co-ordinator
  10. Responsibilities of State and Territory Recall Co-ordinators
  11. Follow-up action
  12. Commonwealth Therapeutic Goods Act 1989 requirements
  13. Commonwealth Trade Practices Act 1974 requirements
  • Appendices
    1. Medicine problem report form
    2. Medical device incident report forms
    3. Human blood and tissues recall report form
    4. Co-ordinators
    5. Parties advised of recall by the Australian Recall Co-ordinator
    6. Authorised persons form
    7. Recall envelopes diagram
    8. Example of a recall letter & facsimile reply form
    9. Example of a consumer level print media advertisement

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Content last updated: Monday, 16 April 2012

Content last reviewed: Monday, 16 April 2012

Web page last updated: Monday, 16 April 2012

URL: http://www.tga.gov.au/industry/recalls-urptg.htm