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Australia: TGA updates uniform recall procedure

2022/07/06  TGA

Introduction
The Uniform Recall Procedure for Therapeutic Goods (URPTG) provides a consistent approach for undertaking recall and non-recall actions for therapeutic goods supplied, imported into or exported from Australia.

The purpose is to assist the sponsor1 to conduct recall and non-recall actions using a standardised and systematic procedure.

It enables sponsors to respond efficiently and effectively to issues with a therapeutic good that has posed, or may pose, a risk to public health and safety.

This procedure is also applicable when the TGA orders an appropriate responsible entity to conduct a mandatory recall. Civil and criminal penalties apply if you do not comply with a mandatory recall.

Undertaking recalls and non-recall actions - overview
Recalls
A product recall is taken to protect the health and safety of consumers from therapeutic goods that are, or may be, affected by an issue with a therapeutic good in relation to its:

  • safety
  • efficacy (medicines and biologicals)
  • performance (medical devices)
  • presentation
  • quality (for recall purposes, does not include the grade of materials or workmanship).

These issues may be due to non-compliance with specified standards or legislative or manufacturing requirements applicable to the therapeutic good.

Non-recall actions
Not all issues require recall actions. You can undertake a non-recall action if:

  • the therapeutic goods meet all specifications and standards
    AND
  • there are no deficiencies in safety, quality, efficacy, performance or presentation. More information is available about types of non-recall actions.

Undertaking the action
To protect public health and safety, it is important that any recall or non-recall action:

  • is undertaken by the sponsor responsible for the therapeutic goods
  • follows the recall procedure
  • involves all those who have a role in the recall.

Identifying issues Anyone
within the supply chain could identify an issue that requires either a recall or non-recall action including:

  • The manufacturer (through the implementation of their Quality Management System)
  • The Australian sponsor (through adverse event reports or complaints)
  • TGA (through our post-market monitoring and compliance activities)
  • Other regulators, who notify TGA through international collaborative activities
  • Third party audits (e.g. by clients), inspections by other regulators and other avenues.

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